Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT07246993
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Targeting Neuroplasticity for Persistent Post-Concussive Cognitive Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'double-blind, randomized, sham-controlled clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-10-30', 'studyFirstSubmitQcDate': '2025-11-21', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of active tDCS combined with cognitive training compared to sham tDCS combined with cognitive training for improving executive function in individuals with PPCS', 'timeFrame': 'Week 4', 'description': 'Using score on Penn Cognitive Battery'}], 'secondaryOutcomes': [{'measure': 'Effects of active versus sham tDCS combined with cognitive training on self-reported affect, stress, cognition, and objectively measured sleep and activity levels', 'timeFrame': 'Week 4', 'description': 'Ecological Momentary Assessment Survey score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Persistent Post Concussion Syndrome', 'Mild Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'This project investigates an innovative combination of non-invasive neuromodulation (transcranial direct current stimulation - tDCS) and cognitive training as a novel treatment approach aimed at improving function in individuals suffering from persistent post-concussive syndrome (PPCS) following mild traumatic brain injury (mTBI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65\n* Has sustained a single mTBI 3-12 months prior to enrollment\n* Meets criteria for PPCS (assessed using the CP Screen)\n* Has reliable access to a smartphone\n\nExclusion Criteria:\n\n* Inability to provide informed consent or complete study procedures\n* History of moderate/severe TBI\n* Significant neurological or psychiatric disorders (other than PPCS-related symptoms like mild depression/anxiety)\n* Substance dependence within the last six months\n* Contraindications to tDCS (e.g., implanted metal, skin lesions on scalp)'}, 'identificationModule': {'nctId': 'NCT07246993', 'briefTitle': 'Targeting Neuroplasticity for Persistent Post-Concussive Cognitive Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Targeting Neuroplasticity for Persistent Post-Concussive Cognitive Symptoms: A Trial of tDCS and Cognitive Training 3-12 Months Post-mTBI', 'orgStudyIdInfo': {'id': 'PSYCH-2025-34246'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active tDCS + Cognitive Training', 'interventionNames': ['Device: Active tDCS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sham tDCS + Cognitive Training', 'interventionNames': ['Device: Sham tDCS']}], 'interventions': [{'name': 'Active tDCS', 'type': 'DEVICE', 'description': 'All participants will receive 10 sessions of cognitive training focused on executive functions, delivered over approximately 3 weeks. Cognitive training will be completed on a lab provided computer using PositScience BrainHQ or TaskFlow software. Concurrently, during each training session, participants will receive either active or sham tDCS. Stimulation will be delivered via saline-soaked sponge electrodes using the Soterix 1x1 miniCT TES device. The anode (active electrode) will be placed over the L-DLPFC (approximated by EEG coordinate F3) and the cathode (reference electrode) over the contralateral supraorbital area (Fp2). The active tDCS group will receive 2mA constant current for 20 minutes.', 'armGroupLabels': ['Active tDCS + Cognitive Training']}, {'name': 'Sham tDCS', 'type': 'DEVICE', 'description': 'All participants will receive 10 sessions of cognitive training focused on executive functions, delivered over approximately 3 weeks. Cognitive training will be completed on a lab provided computer using PositScience BrainHQ or TaskFlow software. Concurrently, during each training session, participants will receive either active or sham tDCS. Stimulation will be delivered via saline-soaked sponge electrodes using the Soterix 1x1 miniCT TES device. The anode (active electrode) will be placed over the L-DLPFC (approximated by EEG coordinate F3) and the cathode (reference electrode) over the contralateral supraorbital area (Fp2). The sham tDCS group will receive a brief ramp up and ramp down of current at the beginning and end of the 20 minutes to mimic the sensation of active stimulation.', 'armGroupLabels': ['Sham tDCS + Cognitive Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'contacts': [{'name': 'Melanie Stimac', 'role': 'CONTACT', 'email': 'stima011@umn.edu', 'phone': '612-301-2549'}], 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'centralContacts': [{'name': 'Melanie Stimac', 'role': 'CONTACT', 'email': 'stima011@umn.edu', 'phone': '612-301-2549'}], 'overallOfficials': [{'name': 'Kelvin Lim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}