Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT01504958
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2011-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effects of a Combined Transcranial Magnetic Stimulation (TMS) and Cognitive Training in Alzheimer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}, {'id': 'D000091942', 'term': 'Cognitive Training'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'apleone@bidmc.harvard.edu', 'phone': '617-667-0203', 'title': 'Alvaro Pascual-Leone, M.D., Ph.D.', 'organization': 'Beth Israel Deaconess Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from baseline to 1 month post-treatment', 'description': 'All adverse events were self-reported according to a Side Effects Questionnaire administered at each visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Active rTMS With Real Cognitive Training', 'description': "High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).\n\nRepetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).\n\nSham participants will receive the same study procedures as patients receiving active rTMS.\n\nNICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).\n\nA particular cognitive exercise will start 200msec after the termination of each TMS train.\n\nSham participants receive real cognitive training that follows the same procedures as the active group.", 'otherNumAtRisk': 10, 'otherNumAffected': 5, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham rTMS With Real Cognitive Training', 'description': "High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).\n\nRepetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).\n\nSham participants will receive the same study procedures as patients receiving active rTMS.\n\nNICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).\n\nA particular cognitive exercise will start 200msec after the termination of each TMS train.\n\nSham participants receive real cognitive training that follows the same procedures as the active group.", 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Sham rTMS With Sham Cognitive Training', 'description': "High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).\n\nRepetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).\n\nSham participants will receive the same study procedures as patients receiving active rTMS.\n\nSham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group", 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Muscle Twitching', 'notes': 'Subject experienced twitching in bicep and wrist flexor of the right arm at the beginning of a TMS session that lasted for 5 seconds and resolved. Subject also reported nausea and session was discontinued.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Headache', 'notes': 'Reported headaches ranged from mild to moderate post-intervention as compared to pre-intervention. Most were assessed as possibly/probably related to the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Neck Pain', 'notes': 'Reported mild neck pain/stiffness post-intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Scalp Pain', 'notes': 'Reported mild scalp pain post-intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Hearing Impairment', 'notes': 'Reported mild hearing impairment post-intervention as compared to pre-intervention. Earplugs were worn throughout every session. No long term hearing impairment reported.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Impaired Cognition', 'notes': 'Reported mild impaired cognition post-intervention compared to pre-intervention. Most reported as tiredness. No long term impairment reported.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Trouble Concentrating', 'notes': 'Reported mild trouble concentrating post-intervention as compared to pre-intervention. Most reported as tiredness. No long term trouble reported.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Tiredness', 'notes': 'Reported mild tiredness post-intervention as compared to pre-intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Soreness', 'notes': 'Participant reported mild soreness at the inferior frontal gyrus (stimulation site) post-stimulation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Blurry Vision', 'notes': 'Blurry vision reported after looking at computer screen for extended period of time', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Anxiousness', 'notes': 'Reported increase in anxiety post-intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Dizziness', 'notes': 'Reported mild dizziness post-intervention as compared to pre-intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Depression', 'notes': 'Participant reported feeling mildly subdued/dazed/depressed following intervention. No long term effects.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Achiness', 'notes': 'Reported mild achiness post-intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Muscle Heaviness', 'notes': 'Reported mild eye heaviness post-intervention. No long term effects.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}], 'seriousEvents': [{'term': 'Rib Fracture', 'notes': 'A subject sustained a 5cm contusion and subtle rib fracture resulting from a fall at home. Subject was brought to the hospital for evaluation. Subject was in the follow up phase. This was assessed as unlikely related to to the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active rTMS With Real Cognitive Training', 'description': "High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).\n\nRepetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).\n\nSham participants will receive the same study procedures as patients receiving active rTMS.\n\nNICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).\n\nA particular cognitive exercise will start 200msec after the termination of each TMS train.\n\nSham participants receive real cognitive training that follows the same procedures as the active group."}, {'id': 'OG001', 'title': 'Sham rTMS With Real Cognitive Training', 'description': "High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).\n\nRepetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).\n\nSham participants will receive the same study procedures as patients receiving active rTMS.\n\nNICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).\n\nA particular cognitive exercise will start 200msec after the termination of each TMS train.\n\nSham participants receive real cognitive training that follows the same procedures as the active group."}, {'id': 'OG002', 'title': 'Sham rTMS With Sham Cognitive Training', 'description': "High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).\n\nRepetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).\n\nSham participants will receive the same study procedures as patients receiving active rTMS.\n\nSham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"}], 'classes': [{'categories': [{'measurements': [{'value': '1.79', 'spread': '3.60', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '5.45', 'groupId': 'OG001'}, {'value': '-0.66', 'spread': '2.91', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre treatment; 1 month post treatment', 'description': "Assessment to measure the severity of all of the most important symptoms of Alzheimer's disease: loss of memory, language, praxis, and attention. The total scoring range is 0-70, with 0 representing the least impairment and 70 the most severe impairment. The results posted below represent a change in score from baseline. A positive change represents an improvement on the ADAS-Cog (change = 1 month score - baseline score).", 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression of Change (CGIC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active rTMS With Real Cognitive Training', 'description': "High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).\n\nRepetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).\n\nSham participants will receive the same study procedures as patients receiving active rTMS.\n\nNICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).\n\nA particular cognitive exercise will start 200msec after the termination of each TMS train.\n\nSham participants receive real cognitive training that follows the same procedures as the active group."}, {'id': 'OG001', 'title': 'Sham rTMS With Real Cognitive Training', 'description': "High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).\n\nRepetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).\n\nSham participants will receive the same study procedures as patients receiving active rTMS.\n\nNICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).\n\nA particular cognitive exercise will start 200msec after the termination of each TMS train.\n\nSham participants receive real cognitive training that follows the same procedures as the active group."}, {'id': 'OG002', 'title': 'Sham rTMS With Sham Cognitive Training', 'description': "High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).\n\nRepetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).\n\nSham participants will receive the same study procedures as patients receiving active rTMS.\n\nSham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"}], 'classes': [{'categories': [{'measurements': [{'value': '3.25', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '4.40', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '4.08', 'spread': '1.02', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-treatment, 1 month post treatment', 'description': 'The CGI is a three-item scale used to assess treatment response in psychiatric patients. The CGI-C subset measures the global improvement or change from baseline. Scores range from 0 to 7, with 0 indicating marked improvement and 7 indicating marked worsening. The scores below represent the percent change of the scores from baseline.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active rTMS With Real Cognitive Training', 'description': "High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).\n\nRepetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).\n\nSham participants will receive the same study procedures as patients receiving active rTMS.\n\nNICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).\n\nA particular cognitive exercise will start 200msec after the termination of each TMS train.\n\nSham participants receive real cognitive training that follows the same procedures as the active group."}, {'id': 'OG001', 'title': 'Sham rTMS With Real Cognitive Training', 'description': "High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).\n\nRepetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).\n\nSham participants will receive the same study procedures as patients receiving active rTMS.\n\nNICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).\n\nA particular cognitive exercise will start 200msec after the termination of each TMS train.\n\nSham participants receive real cognitive training that follows the same procedures as the active group."}, {'id': 'OG002', 'title': 'Sham rTMS With Sham Cognitive Training', 'description': "High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).\n\nRepetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).\n\nSham participants will receive the same study procedures as patients receiving active rTMS.\n\nSham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"}], 'classes': [{'title': 'Pre-Treatment', 'categories': [{'measurements': [{'value': '72.67', 'spread': '5.07', 'groupId': 'OG000'}, {'value': '73.60', 'spread': '3.36', 'groupId': 'OG001'}, {'value': '65.75', 'spread': '6.80', 'groupId': 'OG002'}]}]}, {'title': 'Post-Treatment', 'categories': [{'measurements': [{'value': '69.78', 'spread': '7.80', 'groupId': 'OG000'}, {'value': '71.20', 'spread': '5.93', 'groupId': 'OG001'}, {'value': '61.75', 'spread': '9.50', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-treatment, 1 month Post-treatment', 'description': '23 item scale to assess activities of daily living. Scores range from 0 to 78 with a higher score indicating less functional impairment. The scores reported below are the means of the actual scores from the assessments representing the percent change from baseline.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active rTMS With Real Cognitive Training', 'description': "High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).\n\nRepetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).\n\nSham participants will receive the same study procedures as patients receiving active rTMS.\n\nNICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).\n\nA particular cognitive exercise will start 200msec after the termination of each TMS train.\n\nSham participants receive real cognitive training that follows the same procedures as the active group."}, {'id': 'FG001', 'title': 'Sham rTMS With Real Cognitive Training', 'description': "High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).\n\nRepetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).\n\nSham participants will receive the same study procedures as patients receiving active rTMS.\n\nNICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).\n\nA particular cognitive exercise will start 200msec after the termination of each TMS train.\n\nSham participants receive real cognitive training that follows the same procedures as the active group."}, {'id': 'FG002', 'title': 'Sham rTMS With Sham Cognitive Training', 'description': "High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).\n\nRepetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).\n\nSham participants will receive the same study procedures as patients receiving active rTMS.\n\nSham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Baseline clinical, cognitive, and behavioral assessments: TMS-EMG measures, MRI scan, randomization.', 'groupId': 'FG000', 'numSubjects': '10'}, {'comment': 'Baseline clinical, cognitive, and behavioral assessments: TMS-EMG measures, MRI scan, randomization.', 'groupId': 'FG001', 'numSubjects': '6'}, {'comment': 'Baseline clinical, cognitive, and behavioral assessments: TMS-EMG measures, MRI scan, randomization.', 'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '1 Month Post-Treatment Follow Up', 'groupId': 'FG000', 'numSubjects': '10'}, {'comment': '1 Month Post-Treatment Follow Up', 'groupId': 'FG001', 'numSubjects': '6'}, {'comment': '1 Month Post-Treatment Follow Up', 'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Active rTMS With Real Cognitive Training', 'description': "High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).\n\nRepetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).\n\nSham participants will receive the same study procedures as patients receiving active rTMS.\n\nNICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).\n\nA particular cognitive exercise will start 200msec after the termination of each TMS train.\n\nSham participants receive real cognitive training that follows the same procedures as the active group."}, {'id': 'BG001', 'title': 'Sham rTMS With Real Cognitive Training', 'description': "High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).\n\nRepetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).\n\nSham participants will receive the same study procedures as patients receiving active rTMS.\n\nNICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).\n\nA particular cognitive exercise will start 200msec after the termination of each TMS train.\n\nSham participants receive real cognitive training that follows the same procedures as the active group."}, {'id': 'BG002', 'title': 'Sham rTMS With Sham Cognitive Training', 'description': "High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).\n\nRepetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).\n\nSham participants will receive the same study procedures as patients receiving active rTMS.\n\nSham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.1', 'groupId': 'BG000', 'lowerLimit': '52', 'upperLimit': '76'}, {'value': '68.6', 'groupId': 'BG001', 'lowerLimit': '54', 'upperLimit': '86'}, {'value': '70', 'groupId': 'BG002', 'lowerLimit': '54', 'upperLimit': '86'}, {'value': '69.24', 'groupId': 'BG003', 'lowerLimit': '52', 'upperLimit': '86'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Total number analyzed: 21 (1 enrolled was excluded from analysis) Real/Real: 10 Real/Sham: 5 Sham/Sham: 6'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-05', 'studyFirstSubmitDate': '2011-09-29', 'resultsFirstSubmitDate': '2017-01-13', 'studyFirstSubmitQcDate': '2012-01-04', 'lastUpdatePostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-28', 'studyFirstPostDateStruct': {'date': '2012-01-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)", 'timeFrame': 'Pre treatment; 1 month post treatment', 'description': "Assessment to measure the severity of all of the most important symptoms of Alzheimer's disease: loss of memory, language, praxis, and attention. The total scoring range is 0-70, with 0 representing the least impairment and 70 the most severe impairment. The results posted below represent a change in score from baseline. A positive change represents an improvement on the ADAS-Cog (change = 1 month score - baseline score)."}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impression of Change (CGIC)', 'timeFrame': 'Pre-treatment, 1 month post treatment', 'description': 'The CGI is a three-item scale used to assess treatment response in psychiatric patients. The CGI-C subset measures the global improvement or change from baseline. Scores range from 0 to 7, with 0 indicating marked improvement and 7 indicating marked worsening. The scores below represent the percent change of the scores from baseline.'}, {'measure': "Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)", 'timeFrame': 'Pre-treatment, 1 month Post-treatment', 'description': '23 item scale to assess activities of daily living. Scores range from 0 to 78 with a higher score indicating less functional impairment. The scores reported below are the means of the actual scores from the assessments representing the percent change from baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Alzheimer's disease", 'Cognitive Training', 'Transcranial Magnetic Stimulation'], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '21246222', 'type': 'BACKGROUND', 'citation': "Bentwich J, Dobronevsky E, Aichenbaum S, Shorer R, Peretz R, Khaigrekht M, Marton RG, Rabey JM. Beneficial effect of repetitive transcranial magnetic stimulation combined with cognitive training for the treatment of Alzheimer's disease: a proof of concept study. J Neural Transm (Vienna). 2011 Mar;118(3):463-71. doi: 10.1007/s00702-010-0578-1. Epub 2011 Jan 19."}, {'pmid': '32733232', 'type': 'DERIVED', 'citation': "Brem AK, Di Iorio R, Fried PJ, Oliveira-Maia AJ, Marra C, Profice P, Quaranta D, Schilberg L, Atkinson NJ, Seligson EE, Rossini PM, Pascual-Leone A. Corticomotor Plasticity Predicts Clinical Efficacy of Combined Neuromodulation and Cognitive Training in Alzheimer's Disease. Front Aging Neurosci. 2020 Jul 8;12:200. doi: 10.3389/fnagi.2020.00200. eCollection 2020."}], 'seeAlsoLinks': [{'url': 'http://www.neuronixmedical.com/neuroAD/', 'label': "Related Information to the Alzheimer's Trial; sponsors website."}, {'url': 'http://tmslab.org/', 'label': 'Related Information regarding the TMS lab at Beth Israel Deaconess Medical Center'}]}, 'descriptionModule': {'briefSummary': "This study looks at the potential benefits of combining cognitive training (mental exercises) together with transcranial magnetic stimulation (also known as TMS) to see if this can make a difference in the condition of people with Alzheimer's disease by improving their disease and the cognitive decline that goes along with it.", 'detailedDescription': 'This study takes place in Boston, Massachusetts and Beth Israel Deaconess Medical Center. The treatment portion of the study requires patients to visit the BIDMC daily, Monday through Friday, for 6 weeks. All participants will receive real cognitive training, but half of our participants will receive active TMS treatment and half will receive a placebo TMS treatment. However, those receiving the placebo treatment will be offered the real treatment upon the completion of the study. This study goes up to approximately 4.5 months.\n\nTMS is a noninvasive way of stimulating the brain, which is not painful and does not involve any needles or any form of surgery. It acts by delivering a magnetic stimulation to a particular region of your brain and that, coupled with the cognitive training, is what is being looked at in this study. The investigators are examining if this combination of TMS and cognitive training will improve your memory function and other mental functions such as language, orientation, and thinking or judgment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female age 55-90\n* Diagnosed with mild to moderate AD according to DSM-IV criteria\n* Diagnosis of dementia of the Alzheimer's type according to the criteria established by the NINCDS-ADRDA\n* Normal or corrected normal ability to see and hear\n* Primary language is English\n\nExclusion Criteria:\n\n* IQ below 85\n* Any major structural abnormalities on MRI (eg. Infarction, intracerebral malformation)\n* Any symptoms of disease or abnormalities sufficient to cause memory impairment other than AD (eg. Normal pressure hydrocephalus, progressive supranuclear palsy)\n* Any functional psychiatric disorder (eg. Schizophrenia)\n* Chronic uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (eg. Cardiac malformation)\n* History of seizures, diagnosis of epilepsy\n* Metal implants excluding dental fillings or any of the following medical devices: pacemaker, implanted medication pump, vagal nerve stimulator, deep brain stimulator, TENS unit (unless removed completely for this study), cerebral spinal fluid shunt\n* Recent withdrawal from the following drugs: alcohol, barbiturates, benzodiazepines, meprobamate, chloral hydrate"}, 'identificationModule': {'nctId': 'NCT01504958', 'briefTitle': 'Effects of a Combined Transcranial Magnetic Stimulation (TMS) and Cognitive Training in Alzheimer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Effects of a Combined TMS and Cognitive Training in Alzheimer Patients: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study', 'orgStudyIdInfo': {'id': '2010P000325'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active rTMS with real cognitive training', 'description': "High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area) paired with concurrent active cognitive training.", 'interventionNames': ['Device: Repetitive Transcranial Magnetic Stimulation (rTMS)', 'Behavioral: NICE Cognitive Training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham rTMS with real cognitive training', 'description': "High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area) paired with concurrent active cognitive training.", 'interventionNames': ['Device: Repetitive Transcranial Magnetic Stimulation (rTMS)', 'Behavioral: NICE Cognitive Training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham rTMS with sham cognitive training', 'description': "High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area) paired with concurrent sham cognitive training.", 'interventionNames': ['Device: Repetitive Transcranial Magnetic Stimulation (rTMS)', 'Behavioral: NICE Cognitive Training']}], 'interventions': [{'name': 'Repetitive Transcranial Magnetic Stimulation (rTMS)', 'type': 'DEVICE', 'otherNames': ['Transcranial Magnetic Stimulation', 'Noninvasive Brain Stimulation'], 'description': 'Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).\n\nSham participants will receive the same study procedures as patients receiving active rTMS.', 'armGroupLabels': ['Active rTMS with real cognitive training', 'Sham rTMS with real cognitive training', 'Sham rTMS with sham cognitive training']}, {'name': 'NICE Cognitive Training', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive Training', 'Mental exercises'], 'description': '12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).\n\nA particular cognitive exercise will start 200msec after the termination of each TMS train.\n\nSham participants receive sham cognitive training that follows the same procedures as the active group.', 'armGroupLabels': ['Active rTMS with real cognitive training', 'Sham rTMS with real cognitive training', 'Sham rTMS with sham cognitive training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Alvaro Pascual-Leone, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Neuronix Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurology', 'investigatorFullName': 'Alvaro Pascual-Leone', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}