Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-28 @ 4:34 PM
Study NCT ID:
NCT05816603
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2023-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Direct Current Stimulation for Post-stroke Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2023-04-03', 'studyFirstSubmitQcDate': '2023-04-03', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change from baseline Fatigue Severity Scale - 7 (FSS-7)', 'timeFrame': 'Screening (-1 to -14 days), Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52))', 'description': "Fatigue Severity. This seven item scale measures fatigue severity and it's effect on a person's lifestyle and activities. Items are scored on a seven point scale. Minimum score = 7, maximum score = 49 with higher score indicating greater fatigue severity."}], 'secondaryOutcomes': [{'measure': 'Mean change from baseline Stroke Specific Quality Of Life scale (SS-QOL)', 'timeFrame': 'Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)', 'description': 'Quality of Life. Assesses health related quality of life, specific to individuals with stroke. Composed of 49 items, score on a 5 point guttman type scale. Scores range from 49 to 245, with higher score indicating better functioning.'}, {'measure': 'Mean change from baseline Patient Health Questionnaire - 9 (PHQ-9)', 'timeFrame': 'Screening (-1 to -14 days), Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)', 'description': 'Depression. A multipurpose instrument for screening, measuring, and monitoring severity of depression. Scores range from 0-27, with higher score indicating greater severity of depression.'}, {'measure': 'Mean change from baseline Generalized Anxiety Disorder - 7 (GAD-7)', 'timeFrame': 'Screening (-1 to -14 days), Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)', 'description': 'Anxiety. A multipurpose instrument for screening, measuring, and monitoring severity of anxiety. Scores range from 0-21, with higher score indicating greater severity of anxiety.'}, {'measure': 'Mean change from baseline PROMIS-sleep disturbance', 'timeFrame': 'Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)', 'description': 'Sleep. A domain focused self report of global, physical, mental, and social health for those living with a chronic condition. Computer adapted test with higher scores indicating more sleep disturbance. Results reported as a T-score with range from 10-90 based on the United States general population average score of 50 and standard deviation of 10. Higher t-score indicates greater sleep disturbance.'}, {'measure': 'Mean change from baseline Symbol Digit Modalities Test (SDMT)', 'timeFrame': 'Baseline (Day 1), Post-Treatment (Day 14-21)', 'description': 'Cognition. A measure of cognitive processing speed and attention. Scores range from 0-120, with higher scores better performance.'}, {'measure': 'Mean change from baseline Test of Variables of Attention (T.O.V.A)', 'timeFrame': 'Baseline (Day 1), Post-Treatment (Day 14-21)', 'description': 'Cognition. A computerized test that measures short-term memory, with scores from 85-115 indicating a normal result. Response time, response time variability, commissions, and omissions are also recorded. A higher total number correct score indicates better performance.'}, {'measure': 'Mean change from baseline Montreal cognitive assessment (MoCA)', 'timeFrame': 'Baseline (Day 1), Post-Treatment (Day 14-21)', 'description': 'Cognition. A brief screening tool to assess global cognitive functioning and detect mild cognitive dysfunction. Scored from 0-30 with higher score indicating better performance.'}, {'measure': 'Mean Client Satisfaction Questionnaire - 8 (CSQ-8)', 'timeFrame': 'During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)', 'description': 'Feasibility. This tool is a self-report measure participant satisfaction with the intervention. Scored 8-32 with higher scores indicating greater satisfaction.'}, {'measure': 'Mean change from baseline Frenchay activities index', 'timeFrame': 'Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)', 'description': 'Activities of Daily Living (ADLs). A measure of instrumental ADLs (domestic chores, leisure/work, outdoor activities) for individuals recovering from stroke. Scored from 15-60 with higher score indicating improved functioning.'}, {'measure': 'Change in resting state brain functional connectivity.', 'timeFrame': 'Baseline (Day 1), Post-treatment (Day 14-21)', 'description': 'Change in functional connectivity in the active vs. the sham arms assessed by a resting state functional magnetic resonance imaging scan (rs-fMRI).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Fatigue', 'Stroke Rehabilitaion']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that delivery of anodal tDCS to the left frontal head region will reduce fatigue severity following stroke.', 'detailedDescription': 'The purpose of this study is to investigate transcranial direct current stimulation (tDCS) as a home-based non-pharmacologic intervention for post-stroke fatigue (PSF). Investigators will perform a double-blind, sham-controlled, randomized clinical trial with 24 subjects; 12 will receive sham stimulation and 12 will receive real stimulation. After a baseline assessment, the tDCS device will be applied for 20 minutes, once daily over the left dorsolateral prefrontal cortex (DLPFC), for a total of two weeks. Follow-up assessments with outcome metrics will be completed after the seventh and fourteenth sessions, and one-month following the start date (2 weeks post-treatment). Neuroimaging will be completed at baseline and post-treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients aged \\>18 years\n* Greater than 3 months from first hemorrhagic or ischemic stroke (subacute to chronic), confirmed through neuroimaging (CT or MRI).\n* Fatigue severity score average \\>4 (severe fatigue)\n* Willingness to remain stable on pharmacologic therapy through the duration of the study.\n* Availability of a caregiver, family member, or friend to be present during the administration of the tDCS intervention.\n\nExclusion Criteria:\n\n* Metal in the head (except mouth) or implanted cranial or thoracic devices (i.e. pacemaker, DBS stimulator)\n* History of seizure\n* History of moderate to severe traumatic brain injury\n* A score of 10 or more on the PHQ-9 or GAD-7 scale, suggestive of moderate to severe depression/anxiety.\n* A score of less than 21 on the MoCA suggesting major neurocognitive disorder.\n* Signs of skin rash, infection, or laceration in the supraorbital region where the tDCS will be applied.\n* Inability to provide informed consent\n* Other major neurological, medical, or psychiatric illnesses that could confound results in the opinion of the site investigator.'}, 'identificationModule': {'nctId': 'NCT05816603', 'briefTitle': 'Transcranial Direct Current Stimulation for Post-stroke Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Home-based Post-stroke Fatigue Treatment Using Transcranial Direct Current Stimulation (tDCS)', 'orgStudyIdInfo': {'id': '22-11025409'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Real tDCS stimulation', 'description': 'Subjects randomized to receive real/active electrical stimulation.', 'interventionNames': ['Device: Real Soterix Mini-CT tDCS stimulator']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS stimulation', 'description': 'Subjects randomized to receive sham/non-activating electrical stimulation.', 'interventionNames': ['Device: Sham Soterix Mini-CT tDCS stimulator']}], 'interventions': [{'name': 'Real Soterix Mini-CT tDCS stimulator', 'type': 'DEVICE', 'description': 'Real transcranial electrical stimulation at 2mA intensity will be delivered to the left dorsolateral prefrontal cortex, 20 minutes/day, 14-day duration.', 'armGroupLabels': ['Real tDCS stimulation']}, {'name': 'Sham Soterix Mini-CT tDCS stimulator', 'type': 'DEVICE', 'description': 'Sham stimulation to the left dorsolateral prefrontal cortex, 20 minutes/day, 14-day duration. The device will ramp up and ramp down current delivery from 0 mA -2 mA - 0 mA over 30 seconds at the start of the 20-minute protocol with no active stimulation until the end of the 20 minutes, at which time the 30-second ramp up/ramp down will be repeated.', 'armGroupLabels': ['Sham tDCS stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Raquel Queiruga, M.A.', 'role': 'CONTACT', 'email': 'rqu4002@med.cornell.edu', 'phone': '212-746-1509'}, {'name': 'Joan Stilling, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Raquel Queiruga, M.A.', 'role': 'CONTACT', 'email': 'rqu4002@med.cornell.edu', 'phone': '(212) 746-1509'}], 'overallOfficials': [{'name': 'Joan M Stilling, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 3 months and ending 5 years following article publication.', 'ipdSharing': 'YES', 'description': 'All of the participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices)', 'accessCriteria': 'To achieve aims in the approved proposal. Proposals may be submitted to the study P.I. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years following publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}