Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-02-28 @ 10:53 PM
Study NCT ID:
NCT03874351
Status:
COMPLETED
Last Update Posted:
2021-12-17
First Post:
2019-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Home-Delivered Neurostimulation for Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'HKnotkov@mjhs.org', 'phone': '646-784-2262', 'title': 'Helena Knotkova, PhD, PhilD', 'organization': 'MJHS Institute for Innovation in Palliative Care, New York, NY'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Three months (through the two-month neurostimulation period plus 30 days after the last stimulation).', 'eventGroups': [{'id': 'EG000', 'title': 'Active tDCS', 'description': 'The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham tDCS', 'description': 'Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Migraine Days Per Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS', 'description': 'The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.'}, {'id': 'OG001', 'title': 'Sham tDCS', 'description': 'Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.'}], 'classes': [{'title': 'Migraine days per month at day 60 of the intervention (primary outcome) (primary)', 'categories': [{'measurements': [{'value': '-8', 'groupId': 'OG000', 'lowerLimit': '-9', 'upperLimit': '0'}, {'value': '-4', 'groupId': 'OG001', 'lowerLimit': '-6', 'upperLimit': '0'}]}]}, {'title': 'Migraine days per month at day 30 of the intervention (secondary outcome)', 'categories': [{'measurements': [{'value': '-3', 'groupId': 'OG000', 'lowerLimit': '-6', 'upperLimit': '-1'}, {'value': '-3', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Day 30 of the intervention (secondary time point), Day 60 of the intervention (primary time point);', 'description': 'A migraine day is defined as any calendar day on which the patient had onset, continuation, or recurrence of a migraine as recorded in the diary. A migraine is defined as a migraine (with or without aura) lasting at least 30 minutes. Any calendar day on which acute migraine medication is used is counted as a migraine day.', 'unitOfMeasure': 'migraine days per month', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who met the Inclusion/Exclusion criteria for the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS', 'description': 'The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.'}, {'id': 'OG001', 'title': 'Sham tDCS', 'description': 'Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.18', 'groupId': 'OG000'}, {'value': '36.36', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 60 of the intervention', 'description': 'determined as a percentage of patients having at least 50% reduction of monthly migraine days between the one-month baseline and post-intervention, in each of the two study groups', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who met the Inclusion/Exclusion criteria of the study'}, {'type': 'SECONDARY', 'title': 'Migraine Attack Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS', 'description': 'The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.'}, {'id': 'OG001', 'title': 'Sham tDCS', 'description': 'Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.'}], 'classes': [{'title': 'Migraine attack frequency at day 60 of the interrvention', 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '0'}, {'value': '-2', 'groupId': 'OG001', 'lowerLimit': '-4', 'upperLimit': '-1'}]}]}, {'title': 'Migraine attack frequency at day 30 of the intervention', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Day 30 of the intervention, Day 60 of the intervention', 'description': "Median change in number of attacks per 30-day period, determined from the patients' diaries", 'unitOfMeasure': 'migraine attacks per month', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who met the Inclusion/Exclusion criteria of the study.'}, {'type': 'SECONDARY', 'title': 'Acute Medication Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS', 'description': 'The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.'}, {'id': 'OG001', 'title': 'Sham tDCS', 'description': 'Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.'}], 'classes': [{'title': 'Acute antimigraine drug use - day 30 of the intervention', 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '0'}, {'value': '-1', 'groupId': 'OG001', 'lowerLimit': '-4', 'upperLimit': '0'}]}]}, {'title': 'Acute antimigraine drug use - day 60 of the intervention', 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-4', 'upperLimit': '0'}, {'value': '-2', 'groupId': 'OG001', 'lowerLimit': '-9', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Day 30 of the intervention, Day 60 of the intervention', 'description': "Acute antimigraine drug use per month determined from the patient's diaries. Median change in number of days on which an acute medication was used.", 'unitOfMeasure': 'Days/month', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who met the Inclusion/Exclusion criteria of the study'}, {'type': 'SECONDARY', 'title': 'Change in Headache Attack Intensity Median Change in NRS From Headache Days in a 30 Day Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS', 'description': 'The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.'}, {'id': 'OG001', 'title': 'Sham tDCS', 'description': 'Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.'}], 'classes': [{'title': 'Change in headache attack intensity - day 30 of the intervention', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '-1', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '0'}]}]}, {'title': 'Change in headache attack intensity - day 60 of the intervention', 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '0'}, {'value': '-1', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Day 30 of the intervention, Day 60 of the intervention;', 'description': "Determined from the 11-point \\[0-10\\] Pain Numerical Rating Scale (Pain NRS) on migraine days in the patients' diaries. Higher ratings on the Pain NRS reflect higher intensity of pain.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who met the Inclusion/Exclusion criteria of the study.'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life: The Migraine Specific Quality of Life Questionnaire (MSQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS', 'description': 'The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.'}, {'id': 'OG001', 'title': 'Sham tDCS', 'description': 'Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.'}], 'classes': [{'title': 'Change in quality of life - day 30 of the intervention', 'categories': [{'measurements': [{'value': '-11', 'groupId': 'OG000', 'lowerLimit': '-18', 'upperLimit': '-5'}, {'value': '-7', 'groupId': 'OG001', 'lowerLimit': '-11', 'upperLimit': '-2'}]}]}, {'title': 'Change in quality of life - day 60 of the intervention', 'categories': [{'measurements': [{'value': '-12', 'groupId': 'OG000', 'lowerLimit': '-18', 'upperLimit': '-10'}, {'value': '-8', 'groupId': 'OG001', 'lowerLimit': '-25', 'upperLimit': '-1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Day 30 of the intervention, Day 60 of the intervention;', 'description': 'Determined from ratings on the migraine-specific MSQ questionnaire. The questionnaire consists of 14 items, each rated on a scale 1-6, with the total score ranging between 14 and 84. Higher scores reflect poorer quality of life.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who met the Inclusion/Exclusion criteria of the study.'}, {'type': 'SECONDARY', 'title': 'Change in Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS', 'description': 'The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.'}, {'id': 'OG001', 'title': 'Sham tDCS', 'description': 'Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.'}], 'classes': [{'title': 'Change in depressive symptoms - day 30 of the intervention', 'categories': [{'measurements': [{'value': '-4', 'groupId': 'OG000', 'lowerLimit': '-7', 'upperLimit': '-3'}, {'value': '-2', 'groupId': 'OG001', 'lowerLimit': '-4', 'upperLimit': '0'}]}]}, {'title': 'Change in depressive symptoms - day 60 of the intervention', 'categories': [{'measurements': [{'value': '-5', 'groupId': 'OG000', 'lowerLimit': '-7', 'upperLimit': '-4'}, {'value': '-3', 'groupId': 'OG001', 'lowerLimit': '-6', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Day 30 of the intervention, Day 60 of the intervention;', 'description': 'Determined from the Hamilton Depression Scale (HamD) that consists of 21 items with numerically rated responses ranging 0-2 or 0-4. Higher Ham-D score reflects more severe depression.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who met the Inclusion/Exclusion criteria of the study'}, {'type': 'SECONDARY', 'title': 'Tolerability of the Study Intervention: Number of Side Effects and Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS', 'description': 'The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.'}, {'id': 'OG001', 'title': 'Sham tDCS', 'description': 'Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from Day 1 of the study intervention to the end of the safety follow-up thirty days after the last tDCS application', 'description': 'Determined as number of side effects and adverse events related, probably related or possibly related to the study intevention', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who met the Inclusion/Exclusion criteria of the study.'}, {'type': 'SECONDARY', 'title': "Patient's Satisfaction: 8-item tDCS User Survey", 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS', 'description': 'The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.'}, {'id': 'OG001', 'title': 'Sham tDCS', 'description': 'Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 60 of the intervention', 'description': "Patient's satisfaction with the study intervention determined from the 8-item tDCS User Survey at the end of the intervention. Each item of the Survey is a brief statement and a respondent indicates if s/he Strongly Agree, Agree, Neither Agree or Disagree, Disagree or Strongly Disagree with the statement. Higher number of Agree/Strongly Agree ratings reflects higher satisfaction with the tDCS procedure.", 'unitOfMeasure': 'number of Agree/Strongly Agree ratings', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who met the Inclusion/Exclusion criteria of the study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active tDCS', 'description': 'The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.'}, {'id': 'FG001', 'title': 'Sham tDCS', 'description': 'Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were recruited at the New York Headache Center, New York City, NY, USA, between 3/12/2019 and 3/5/2020.', 'preAssignmentDetails': 'Thirty six patients have been identified. Six declined to participate, 14 did not meet the Inclusion/Exclusion criteria. Twenty two proceeded with the study, were randomized and received the study intervention. The first of the twenty-two patients entered the study on 4/22/19; the last patient out completed the study intervention on 4/10/2020, with the last study visit on 4/13/2020 and the last phone follow-up on 5/12/2020.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active tDCS', 'description': 'The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.'}, {'id': 'BG001', 'title': 'Sham tDCS', 'description': 'Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.\n\nnon-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White, Non-Hispanic', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Migraine days per month', 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '29'}, {'value': '17', 'groupId': 'BG001', 'lowerLimit': '9', 'upperLimit': '27'}, {'value': '23', 'groupId': 'BG002', 'lowerLimit': '11', 'upperLimit': '28'}]}]}], 'paramType': 'MEDIAN', 'description': 'Number of migraine days per month, as reported by participants.', 'unitOfMeasure': 'migraine days per month', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-26', 'size': 344456, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-15T11:57', 'hasProtocol': True}, {'date': '2020-01-29', 'size': 166064, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-11-04T11:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-09', 'studyFirstSubmitDate': '2019-03-12', 'resultsFirstSubmitDate': '2021-09-15', 'studyFirstSubmitQcDate': '2019-03-13', 'lastUpdatePostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-04', 'studyFirstPostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Migraine Days Per Month', 'timeFrame': 'Baseline, Day 30 of the intervention (secondary time point), Day 60 of the intervention (primary time point);', 'description': 'A migraine day is defined as any calendar day on which the patient had onset, continuation, or recurrence of a migraine as recorded in the diary. A migraine is defined as a migraine (with or without aura) lasting at least 30 minutes. Any calendar day on which acute migraine medication is used is counted as a migraine day.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Responders', 'timeFrame': 'Day 60 of the intervention', 'description': 'determined as a percentage of patients having at least 50% reduction of monthly migraine days between the one-month baseline and post-intervention, in each of the two study groups'}, {'measure': 'Migraine Attack Frequency', 'timeFrame': 'Baseline, Day 30 of the intervention, Day 60 of the intervention', 'description': "Median change in number of attacks per 30-day period, determined from the patients' diaries"}, {'measure': 'Acute Medication Use', 'timeFrame': 'Baseline, Day 30 of the intervention, Day 60 of the intervention', 'description': "Acute antimigraine drug use per month determined from the patient's diaries. Median change in number of days on which an acute medication was used."}, {'measure': 'Change in Headache Attack Intensity Median Change in NRS From Headache Days in a 30 Day Period', 'timeFrame': 'Baseline, Day 30 of the intervention, Day 60 of the intervention;', 'description': "Determined from the 11-point \\[0-10\\] Pain Numerical Rating Scale (Pain NRS) on migraine days in the patients' diaries. Higher ratings on the Pain NRS reflect higher intensity of pain."}, {'measure': 'Change in Quality of Life: The Migraine Specific Quality of Life Questionnaire (MSQ)', 'timeFrame': 'Baseline, Day 30 of the intervention, Day 60 of the intervention;', 'description': 'Determined from ratings on the migraine-specific MSQ questionnaire. The questionnaire consists of 14 items, each rated on a scale 1-6, with the total score ranging between 14 and 84. Higher scores reflect poorer quality of life.'}, {'measure': 'Change in Depressive Symptoms', 'timeFrame': 'Baseline, Day 30 of the intervention, Day 60 of the intervention;', 'description': 'Determined from the Hamilton Depression Scale (HamD) that consists of 21 items with numerically rated responses ranging 0-2 or 0-4. Higher Ham-D score reflects more severe depression.'}, {'measure': 'Tolerability of the Study Intervention: Number of Side Effects and Adverse Events', 'timeFrame': 'from Day 1 of the study intervention to the end of the safety follow-up thirty days after the last tDCS application', 'description': 'Determined as number of side effects and adverse events related, probably related or possibly related to the study intevention'}, {'measure': "Patient's Satisfaction: 8-item tDCS User Survey", 'timeFrame': 'Day 60 of the intervention', 'description': "Patient's satisfaction with the study intervention determined from the 8-item tDCS User Survey at the end of the intervention. Each item of the Survey is a brief statement and a respondent indicates if s/he Strongly Agree, Agree, Neither Agree or Disagree, Disagree or Strongly Disagree with the statement. Higher number of Agree/Strongly Agree ratings reflects higher satisfaction with the tDCS procedure."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Migraine;', 'transcranial direct current stimulation (tDCS)', 'tDCS-Telehealth intervention'], 'conditions': ['Migraine Disorders']}, 'descriptionModule': {'briefSummary': "There is a need for better preventive and abortive therapies for migraine. Previous research has indicated that non-invasive neurostimulation may have prophylactic effects on migraine and improve symptoms and functional outcomes in migraineurs. One such method is a non-invasive transcranial direct current stimulation (tDCS). This double-blind randomized sham-controlled two-parallel-arm study aims to evaluate efficacy and safety of tDCS self-delivered in daily 20-minute applications for 2 months (60 days) by adult migraine patients at home for migraine prevention and migraine symptom management, as compared to sham tDCS application; and to evaluate patients' satisfaction with the procedure.", 'detailedDescription': "This study will employ a double-blind randomized sham-controlled two-parallel-arm design and involve 60 adults with migraine. For each participant, the study will involve 3 study visits and last about 90 days (30 days of the baseline followed by 60 days of the tDCS/sham study intervention). A post-study safety monitoring will continue bi-weekly by phone for 30 days after the last tDCS/sham application.\n\nAt Visit 1, patients will provide written informed consent and undergo screening for the eligibility. This will be followed by 30 days of baseline at home during which patients will keep daily records (Daily Diaries) of migraine occurrence and provide answers to a set of symptom-related questionnaires. Patients with 4 or more migraine days per month who fully meet the study eligibility criteria at the end of the baseline period will be randomized in double-blind manner into two groups: Group 1 will be randomized to receive active tDCS in daily 20-minute applications for 60 days; Group 2 will be randomized to receive sham tDCS in daily 20-minute applications for 60 days, self-applied at home. Following randomization, patients will continue keeping the Daily Diaries and Visit #2 will be held either in the patient's home or in the research facility, based on the patient's preference. tDCS device will be deployed to the patient and instructions on tDCS use will be provided. The first tDCS/sham self-application by the patient will be done at Visit 2. Daily tDCS/sham self-application by the patient at home and records in the form of Daily Diaries will continue for the rest of the 60-day period. Study staff will be in regular remote contact with the patient via phone and/or HIPAA-compliant videoconferencing. Upon conclusion of the intervention, Visit 3 will be held either in the patient's home or in the research facility, based on the patient's preference. tDCS device will be collected from the patient. Safety monitoring will continue bi-weekly by phone for 30 days after the last tDCS/sham application.\n\nOutcome assessment will be carried out at the end of the baseline, and at Day 30 (the secondary time-point) and Day 60 (the primary time-point) of the tDCS/sham intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 - 65 years;\n* Has episodic or chronic migraine with or without aura, diagnosed according to the International Classification of Headache Disorders 3rd edition (ICHD-3) criteria, for at least the past 12 months;\n* Migraine occurring on 4 or more days per month, as documented through the 30-day baseline;\n* No change in prophylactic therapy in 3 months preceding the baseline;\n* If on antidepressant, blood pressure or epilepsy medication for reason other than migraine, the medication regimen is stable for at least 3 months preceding the baseline; Able to follow instructions in English;\n* Understand the informed consent process and provide consent to participate in the study.\n\nExclusion Criteria:\n\n* History of severe head trauma, brain surgery, implants in the head or neck; history of seizures;\n* Skin disorder or skin defects which compromise the integrity or sensitivity of the skin at or near locations where tDCS will be applied;\n* Not able to prepare and operate the tDCS device after being instructed in tDCS use;\n* Not able to respond to questionnaires and rating scales;\n* Concurrent use of another neurostimulation device (such as spinal cord stimulator cardiostimulator, deep brain stimulator, vagus nerve, transcranial magnetic, or supraorbital transcutaneous electric nerve stimulators);\n* Concurrent use of Botox or calcitonin gene-related peptide (CGRP) monoclonal antibodies treatments;\n* Unstable acute medical condition;\n* Any serious, malignant or non-malignant, acute or chronic medical condition or active psychiatric illness that, in the Investigator's opinion, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study;\n* Used any investigational drug, biologic, or device within 30 days prior to screening, or 5 half-lives, whichever is longer;\n* Taking opioid analgesics or barbiturates on more than 2 days a week;\n* Taking medications acting as antagonist on the N-methyl-D-aspartate (NMDA) receptor."}, 'identificationModule': {'nctId': 'NCT03874351', 'briefTitle': 'A Study of Home-Delivered Neurostimulation for Migraine', 'organization': {'class': 'OTHER', 'fullName': 'MJHS Institute for Innovation in Palliative Care'}, 'officialTitle': 'A Randomized Sham-Controlled Study of Home-Delivered Non-Invasive Neurostimulation for Migraine', 'orgStudyIdInfo': {'id': '19008-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active tDCS', 'description': 'Twenty minutes of direct current at intensity of 1.5 milliamperes (mA).', 'interventionNames': ['Device: non-invasive transcranial direct current stimulation (tDCS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS', 'description': 'Thirty seconds of direct current at 1.5 mA, followed by 0 mA for the remaining time of the 20-minute stimulation period.', 'interventionNames': ['Device: non-invasive transcranial direct current stimulation (tDCS)']}], 'interventions': [{'name': 'non-invasive transcranial direct current stimulation (tDCS)', 'type': 'DEVICE', 'description': 'Active tDCS: transcranial direct current stimulation at intensity 1.5mA for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.\n\nSham tDCS: transcranial direct current stimulation at intensity 1.5mA for 30seconds followed by 0 mA current for remaining time of the 20-minute intervention per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.', 'armGroupLabels': ['Active tDCS', 'Sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10006', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'MJHS Institute for Innovation in Palliative Care', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Headache Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Helena Knotkova, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MJHS Institute for Innovation in Palliative Care (MJHSPalliative)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MJHS Institute for Innovation in Palliative Care', 'class': 'OTHER'}, 'collaborators': [{'name': 'New York Headache Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}