Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT07160218
Status:
COMPLETED
Last Update Posted:
2025-09-08
First Post:
2025-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of tDCS and Cognitive Rehabilitation on Cognition and Neural Plasticity in MS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}, {'id': 'D000091942', 'term': 'Cognitive Training'}], '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'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2025-08-26', 'studyFirstSubmitQcDate': '2025-09-04', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in verbal memory performance measured by California Verbal Learning Test-II (CVLT-II)', 'timeFrame': 'Baseline and immediately after 10 intervention sessions', 'description': 'The CVLT-II assesses verbal learning and memory through a word recall task. Scores include total recall, short-delay recall, and long-delay recall. Assessments will be conducted at baseline and after 4 weeks of intervention.'}, {'measure': 'Change in attention performance measured by Integrated Visual and Auditory Continuous Performance Test (IVA-2)', 'timeFrame': 'Baseline and immediately after 10 intervention sessions', 'description': 'The IVA-2 evaluates visual and auditory attention and response control. Scores include full-scale attention quotient, visual attention, auditory attention, and response control. Assessments will be conducted at baseline and post-intervention to assess changes in attention performance'}, {'measure': 'Change in visuospatial memory performance measured by Rey-Osterrieth Complex Figure Test', 'timeFrame': 'Baseline and immediately after 10 intervention sessions', 'description': 'The Rey-Osterrieth Complex Figure Test evaluates visuospatial constructional ability and memory. Participants copy a complex figure (copy trial) and then reproduce it from memory immediately and after a delay. Assessments will be conducted at baseline and after completion of the tDCS intervention to assess changes in visuospatial memory performance.'}, {'measure': 'Change in serum BDNF levels (ng/mL)', 'timeFrame': 'Baseline and immediately after 10 intervention sessions', 'description': 'Serum brain-derived neurotrophic factor (BDNF) concentration will be measured using an enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at baseline and after completion of the tDCS intervention. Changes in BDNF levels will be analyzed to assess neuroplasticity.'}, {'measure': 'Change in white matter integrity measured by Diffusion Tensor Imaging (DTI)', 'timeFrame': 'Baseline and immediately after 10 intervention sessions', 'description': 'White matter integrity will be assessed using DTI MRI scans. Primary metrics include Fractional Anisotropy (FA) and Mean Diffusivity (MD) in predefined brain regions. Scans will be performed at baseline and after completion of the tDCS intervention to evaluate neuroplasticity-related changes'}, {'measure': 'Change in acetylcholinesterase (AChE) activity in blood (U/mL)', 'timeFrame': 'Baseline and immediately after 10 intervention sessions', 'description': 'Acetylcholinesterase activity will be measured in blood samples using a spectrophotometric enzymatic assay. Samples will be collected at baseline and after completion of the tDCS intervention. Changes in AChE activity will be analyzed to assess cholinergic system function and neuroplasticity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate whether transcranial direct current stimulation (tDCS) and cognitive rehabilitation can improve cognitive functions and neuronal plasticity in patients with multiple sclerosis (MS). The participant population consists of MS patients (both sexes, adults), who commonly experience cognitive impairment in addition to physical and psychological symptoms.\n\nThe main questions it aims to answer are:\n\nDoes tDCS applied over the left dorsolateral prefrontal cortex improve cognitive abilities in MS patients?\n\nDoes the combination of tDCS and cognitive rehabilitation enhance neuroplasticity, as measured by DTI, BDNF levels, and acetylcholinesterase activity?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge between 20 and 50 years.\n\nDiagnosed with relapsing-remitting multiple sclerosis (RRMS).\n\nMild disability, defined as EDSS \\< 5.\n\nPatients who attended the neurology clinic and are willing to participate.\n\nExclusion Criteria:\n\nPresence of psychiatric disorders requiring treatment with neuroleptics.\n\nHistory of seizures.\n\nLeft-handed individuals.\n\nRecent MS relapse requiring steroid treatment.\n\nPregnant women.\n\nHistory of brain surgery or presence of intracranial clips.'}, 'identificationModule': {'nctId': 'NCT07160218', 'briefTitle': 'Effects of tDCS and Cognitive Rehabilitation on Cognition and Neural Plasticity in MS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'The Effect of Trans-cranial Direct Current Stimulation and Cognitive Rehabilitation on Cognitive Functions and Neuronal Plasticity inPatients With Multiple Sclerosis: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IR.SBMU.PHNS.REC.1402.121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tDCS', 'description': 'A 30-minute tDCS session with the cathode placed over the left dorsolateral prefrontal cortex (DLPFC)', 'interventionNames': ['Device: tDCS']}, {'type': 'EXPERIMENTAL', 'label': 'tDCS+Cognitive training', 'description': 'A 30-minute tDCS session with the cathode over the left DLPFC combined with computer-based cognitive rehabilitation training', 'interventionNames': ['Device: tDCS', 'Device: Cognitive Rehabilitation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS', 'description': 'Sham stimulation applied over the left DLPFC, mimicking the sensation of tDCS without delivering active current', 'interventionNames': ['Device: Sham tDCS']}], 'interventions': [{'name': 'tDCS', 'type': 'DEVICE', 'description': 'A 30-minute tDCS session with the cathode placed over the left dorsolateral prefrontal cortex (DLPFC), delivered in 10 sessions over 2 weeks. This protocol targets cognitive improvement in MS patients', 'armGroupLabels': ['tDCS', 'tDCS+Cognitive training']}, {'name': 'Cognitive Rehabilitation', 'type': 'DEVICE', 'description': 'computer-based cognitive rehabilitation exercises. Conducted in 10 sessions over 2 weeks to enhance attention, memory, and neuroplasticity in MS patients.', 'armGroupLabels': ['tDCS+Cognitive training']}, {'name': 'Sham tDCS', 'type': 'DEVICE', 'description': 'Sham stimulation applied over the left DLPFC for 30 minutes, mimicking the sensation of tDCS without delivering active current, over 10 sessions, used as control to blind participants to the intervention', 'armGroupLabels': ['Sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Shahid Beheshti University of Medical Science', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data will be made available to qualified researchers. Data sharing will occur after the publication of the primary study results. Requests for data access will be considered on a case-by-case basis and can be initiated by contacting the corresponding author. Data will be shared under a data use agreement to ensure appropriate use and confidentiality'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Neurology', 'investigatorFullName': 'Mehrdad Roozbeh', 'investigatorAffiliation': 'Shahid Beheshti University of Medical Sciences'}}}}