Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-28 @ 11:49 PM
Study NCT ID:
NCT06999304
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-15
First Post:
2025-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot TMS in Mild TBI
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2025-05-12', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Explore pre-post changes concurrent with personalized TMS on PPCS - global post-concussion scale', 'timeFrame': 'baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment', 'description': 'Pre-post change in global post-concussion scale - Rivermead Post-Concussion Symptoms Questionnaire (RPQ) from baseline to 4- and 12-weeks post-enrollment. The RPQ consists of 16 questions about symptoms experienced after a head injury, rated on a scale of 0-4. Range \\[0-64\\]. A higher score indicates more severe symptoms. A positive change from pre to post (post score-pre score=change) indicates that symptoms get worse.'}, {'measure': 'Explore pre-post changes concurrent with personalized TMS on PPCS - generalized anxiety', 'timeFrame': 'baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment', 'description': 'Pre-post change in symptom specific profile scale (general anxiety disorder-7 (GAD7)) from baseline to 4- and 12-weeks post-enrollment. The GAD7 is a 7-item anxiety scale that is self-administered, valid, and an efficient tool for screening for GAD and assessing its severity in clinical practice and research. Range: \\[0-21\\] A higher score indicates more anxiety. A positive change from pre to post (post score-pre score=change) indicates that anxiety symptoms get worse.'}, {'measure': 'Explore pre-post changes concurrent with personalized TMS on PPCS - speed of forgetting', 'timeFrame': 'baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment', 'description': 'Pre-post change in symptom specific profile scale (speed of forgetting (SoF)) from baseline to 4- and 12-weeks post-enrollment. The SOF quantifies the rate of episodic trace decay without the effects of learning. Content is presented as cue-pair associates and assessed through multiple-choice or verbal recall questions. This test is 8 minutes long.\n\nRange: \\[0-1\\]. A higher score indicates more memory impairment. A positive change from pre to post (post score-pre score=change) indicates that memory gets worse.'}, {'measure': 'Explore pre-post changes concurrent with personalized TMS on PPCS - CP screen', 'timeFrame': 'baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment', 'description': 'Pre-post change in Concussion Clinical Profiles Screening (CP) from baseline to 4- and 12-weeks post-enrollment. The CP is a 29 item self report tool to assess clinical profiles associated with concussion. Range: \\[0-87\\]. A higher score indicates more severe symptoms. A positive change from pre to post (post score-pre score=change) indicates that symptoms get worse.'}, {'measure': 'Explore pre-post changes concurrent with personalized TMS on PPCS - respond to treatment', 'timeFrame': 'baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment', 'description': 'Percent of participants that respond to treatment based on improvement in symptom specific scales at 1- 4- and 12-weeks post-enrollment, defined as either show minimally clinically important difference (MCID) ≥2 SD improvement from baseline at a given timepoint'}], 'primaryOutcomes': [{'measure': 'Percentage of participants with anomalous parcellations - developing the method of personalization of TMS for PPCS', 'timeFrame': 'baseline', 'description': 'Percentage of participants matched with anomalous parcellations based on one of the 2 top ranked burdensome symptoms/symptom profile. If an anomalous parcellation matching one of the top 2 ranked symptom profiles can be identified in at least 16 out of 20 (80%) of participants, the trial will be considered a success.'}, {'measure': 'Anomalous parcellations - developing the method of personalization of TMS targets for PPCS', 'timeFrame': 'baseline', 'description': 'Names and number of anomalous parcellations identified using connectivity analysis and targets available to treat with TMS based on symptom profiles'}, {'measure': 'Distribution of complaints for PPCS', 'timeFrame': 'baseline', 'description': 'Distribution of chief symptom/complaints among participants measured by concussion clinical profile (CP) screen'}, {'measure': 'Mapping of complaints to anomalous parcellations', 'timeFrame': 'baseline', 'description': 'Mapping of chief symptom/complaints to parcellations based on literature and connective abnormalities'}], 'secondaryOutcomes': [{'measure': 'Feasibility - rate of completed treatment', 'timeFrame': '4 weeks', 'description': 'Percent of participants who complete 4 out of the 5 treatment visits.'}, {'measure': 'Fidelity', 'timeFrame': '4 weeks', 'description': 'Percent of participants who complete all sessions of treatment.'}, {'measure': 'Safety - adverse events', 'timeFrame': '16 weeks', 'description': 'Frequency of each adverse events.'}, {'measure': 'Acceptability', 'timeFrame': '4 weeks', 'description': "This survey will be used to understand the subject's experience with TMS and whether they feel it is an acceptable form of treatment. Questions will be both open-ended and quantitative (Likert scale). In this study, participants will be asked about their level of satisfaction with various aspects of the treatment. This survey is not standardized. Scores presented as percent of subject responses. Range: \\[0-100\\]. Higher percentage indicates more acceptability to this form of treatment."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['transmagnetic stimulation', 'functional MRI guided theta burst stimulation', 'intermittent theta burst stimulation'], 'conditions': ['Persistent Post Concussive Headache', 'Mild Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'Persistent post-concussive symptoms (PPCS) involve an array of physical, cognitive, and behavioral symptoms lasting more than a month after mild traumatic brain injury (mTBI). 34-44% of people with mTBI or concussion present with a considerable burden of PPCS 3-6 months after injury. There is currently no standardized treatment for PPCS, nor FDA approved medication for any neuropsychiatric or neurocognitive symptoms associated with mTBI. Transcranial magnetic stimulation (TMS) shows promise as a treatment for PPCS; however, the current one-size-fits-all approach does not address the heterogeneity of symptoms. We propose utilization of resting state functional MRI (rs-fMRI) guided rTMS to target personalized brain networks burdened with PPCS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Clinical diagnosis of mTBI at least 4 weeks prior but not exceeding 12 months prior to the time of screening\n2. Age 18-65 years at the time of mTBI\n3. High burden of post concussive symptoms at time of screening, as measured by symptoms questionnaire (PCSS) ≥35\\*\n\nExclusion Criteria:\n\n1. Inability to tolerate imaging; contraindication of imaging due to implants or metal\n2. Seizure disorder, active alcohol or substance use disorder\n3. Inability to speak and read English\n4. Anything else that, in the opinion of the PI/study physician, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.\n5. Subject is pregnant or breast feeding\n6. Subject has participated in a clinical interventional trial in the last 3 months"}, 'identificationModule': {'nctId': 'NCT06999304', 'briefTitle': 'Pilot TMS in Mild TBI', 'organization': {'class': 'OTHER', 'fullName': 'HealthPartners Institute'}, 'officialTitle': 'Personalized Accelerated Theta Burst Transcardial Magnetic Stimulation in Mild Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'A24-141'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Theta burst stimulation', 'description': 'There will be a total of 25 theta burst sessions across 5 treatment visits (5 sessions per treatment visit), over a two-week period. Treatment will be applied to 2 brain regions of interest or parcellations: (1) Left 8AV; 2) A personalized region based on imaging and symptom profile.', 'interventionNames': ['Device: Intermittent theta burst stimulation']}], 'interventions': [{'name': 'Intermittent theta burst stimulation', 'type': 'DEVICE', 'otherNames': ['Transmagnetic stimulation', 'MagVenture'], 'description': 'MagVenture TMS Therapy active coil with theta burst stimulation. Resting motor threshold: 80%; Intermittent theta burst - Number of pulses per session: 1200 pulses; Inter-train interval: 8 seconds; Pulse frequency in burst: 50 Hertz; Continuous theta burst - Number of pulses per session: 1800 pulses; Pulse frequency in burst: 50 Hertz', 'armGroupLabels': ['Theta burst stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55130', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'HealthPartners Neuroscience Center', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Bhavani Kashyap, MBBS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HealthPartners Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No identifiable data will be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HealthPartners Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}