Pilot TMS in Mild TBI

Not Applicable

• Conditions: Persistent Post Concussive Headache; Mild Traumatic Brain Injury

• Registration Number: NCT06999304
• Lead Sponsor: HealthPartners Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-05-22
• Study First Posted: 2025-05-31
• Status Verified: 2025-06
• Study Start: 2025-06
• Last Update Submitted: 2025-06-02
• Last Update Posted: 2025-06-05
• Primary Completion: 2027-04
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Clinical diagnosis of mTBI at least 4 weeks prior but not exceeding 12 months prior to the time of screening
2. Age 18-65 years at the time of mTBI
3. High burden of post concussive symptoms at time of screening, as measured by symptoms questionnaire (PCSS) ≥35*

Exclusion Criteria

1. Inability to tolerate imaging; contraindication of imaging due to implants or metal
2. Seizure disorder, active alcohol or substance use disorder
3. Inability to speak and read English
4. 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.
5. Subject is pregnant or breast feeding
6. Subject has participated in a clinical interventional trial in the last 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of participants with anomalous parcellations - developing the method of personalization of TMS for PPCS	baseline	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.
Anomalous parcellations - developing the method of personalization of TMS targets for PPCS	baseline	Names and number of anomalous parcellations identified using connectivity analysis and targets available to treat with TMS based on symptom profiles
Distribution of complaints for PPCS	baseline	Distribution of chief symptom/complaints among participants measured by concussion clinical profile (CP) screen
Mapping of complaints to anomalous parcellations	baseline	Mapping of chief symptom/complaints to parcellations based on literature and connective abnormalities

Secondary Outcome Measures

Name	Time	Method
Feasibility - rate of completed treatment	4 weeks	Percent of participants who complete 4 out of the 5 treatment visits.
Fidelity	4 weeks	Percent of participants who complete all sessions of treatment.
Safety - adverse events	16 weeks	Frequency of each adverse events.
Acceptability	4 weeks	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.

Trial Locations

Locations (1)

HealthPartners Neuroscience Center; 🇺🇸 Saint Paul, Minnesota, United States