Transcranial Magnetic Stimulation for Concussion

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HealthPartners Institute

Disqualifiers: Seizure disorder, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 2 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Bhavani Kashyap, MBBS, PhD

Principal Investigator

HealthPartners Institute

Eligibility Criteria

This trial is for individuals who have experienced a mild traumatic brain injury (mTBI) or concussion and are dealing with persistent symptoms more than a month after the injury. These symptoms could include physical, cognitive, or behavioral changes.

Inclusion Criteria

I am between 18 and 65 years old.

I was diagnosed with a mild traumatic brain injury between 1 month and 12 months ago.

High burden of post concussive symptoms at time of screening, as measured by symptoms questionnaire (PCSS) ≥35

Exclusion Criteria

Seizure disorder, active alcohol or substance use disorder

Inability to tolerate imaging; contraindication of imaging due to implants or metal

Inability to speak and read English

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive theta burst stimulation with 25 sessions across 5 treatment visits over a two-week period

2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Follow-up assessments at 1, 4, and 12 weeks post-treatment

Treatment Details

Interventions

• Intermittent theta burst stimulation

Trial Overview The trial is testing intermittent theta burst stimulation (TMS), which is a non-invasive treatment that uses magnetic fields to stimulate brain cells. The study aims to personalize this therapy using MRI-guided techniques to target specific brain networks affected by post-concussive symptoms.

Participant Groups

Group I: Theta burst stimulation Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials

196

Recruited

3,721,000+