Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT04697316
Status:
COMPLETED
Last Update Posted:
2024-03-07
First Post:
2020-12-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcranial Direct Current Stimulation (tDCS) as a Cognitive Functioning Enhancement Treatment for ADHD Patients Compared to Healthy Controls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2020-12-31', 'studyFirstSubmitQcDate': '2021-01-05', 'lastUpdatePostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'N-back', 'timeFrame': 'through study completion', 'description': 'change in working memory: increase in hit rate'}, {'measure': 'Stroop', 'timeFrame': 'through study completion, up to 1 hour after treatment', 'description': 'change in interference control: smaller interference effect'}, {'measure': 'Stop-signal', 'timeFrame': 'through study completion, up to 1 hour after treatment', 'description': 'change in response inhibition: shorter SSRT'}, {'measure': 'Time Reproduction task', 'timeFrame': 'through study completion, up to 1 hour after treatment', 'description': 'change in time perception: increased accuracy'}, {'measure': 'Continuous Performance Task', 'timeFrame': 'through study completion, up to 1 hour after treatment', 'description': 'change in continuous concentration: increase in accuracy'}, {'measure': 'Navon task', 'timeFrame': 'through study completion, up to 1 hour after treatment', 'description': "change in accuracy, shorter RT's"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transcranial Direct Current Stimulation']}, 'descriptionModule': {'briefSummary': 'This study will examine the possible effects of tDCS (Transcranial Direct Current Stimulation) treatment to the left DLPFC on cognitive functions which were found to be deficient amongst ADHD patients. The study will include 100 subjects, 50 of whom diagnosed with ADHD. Subjects will complete the ASRS questionnaire to measure ADHD symptoms severity. Next, subjects will complete a series of cognitive tasks, after which they will receive either tDCS treatment or a sham treatment. Finally, subjects will repeat the cognitive tasks. Later that day, a telephonic follow up will take place. ADHD symptoms will be assessed again the next day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:Participation criteria for healthy participants\n\n1. Right hand dominance.\n2. No psychiatric nor neural diagnosis.\n3. Participants must be able to comprehend the study's procedure and sign an informed consent.\n\nParticipation criteria for ADHD diagnosed participants\n\n1. ADHD diagnosis (according to DSM V).\n2. Right hand dominance.\n3. Participants must be able to comprehend the study's procedure and sign an informed consent.\n4. Participants who regularly use Methylphenidate will be required to avoid the medication for 24 hours prior to study and 12 hours post study.\n\n \\-\n\nExclusion Criteria:\n\n* a. Other psychiatric diagnoses (additional to ADHD). b. Drug use (excluding Methylphenidate). c. Neurological disorders. d. Pacemaker, Insulin pump"}, 'identificationModule': {'nctId': 'NCT04697316', 'briefTitle': 'Transcranial Direct Current Stimulation (tDCS) as a Cognitive Functioning Enhancement Treatment for ADHD Patients Compared to Healthy Controls', 'organization': {'class': 'OTHER', 'fullName': 'Hebrew University of Jerusalem'}, 'officialTitle': 'Transcranial Direct Current Stimulation (tDCS) as a Cognitive Functioning Enhancement Treatment for ADHD Patients Compared to Healthy Controls', 'orgStudyIdInfo': {'id': 'tDCS-ADHD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADHD tDCS', 'interventionNames': ['Device: Transcranial Direct Current Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'ADHD Sham', 'interventionNames': ['Device: Sham']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy control tDCS', 'interventionNames': ['Device: Transcranial Direct Current Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Healthy control Sham', 'interventionNames': ['Device: Sham']}], 'interventions': [{'name': 'Transcranial Direct Current Stimulation', 'type': 'DEVICE', 'description': 'To stimulate the left DLPFC, the anode electrode will be placed over F3 and the cathode will be placed over F4. Each stimulation will be applied for 20 min at 2mA intensity.', 'armGroupLabels': ['ADHD tDCS', 'Healthy control tDCS']}, {'name': 'Sham', 'type': 'DEVICE', 'description': 'For the sham treatment, stimulation will be stopped after 30 seconds. Current will be renewed five times throughout the session for 2 seconds each time, to mimic the tDCS stimulation.', 'armGroupLabels': ['ADHD Sham', 'Healthy control Sham']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hebrew University of Jerusalem', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebrew University of Jerusalem', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Noa Beiman', 'investigatorAffiliation': 'Hebrew University of Jerusalem'}}}}