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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat persistent symptoms following a concussion, such as headaches or difficulty concentrating, using transcranial magnetic stimulation (TMS). TMS uses magnetic fields to gently stimulate specific brain regions. The trial employs a personalized approach, targeting brain areas based on each participant's symptoms and brain imaging. It suits individuals who experienced a concussion in the past year and continue to face significant symptoms. Participants will undergo multiple sessions of this promising treatment, known as intermittent theta burst stimulation, over two weeks. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for concussion symptoms.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that transcranial magnetic stimulation is safe for treating persistent post-concussive symptoms?

Research has shown that intermittent theta burst stimulation (iTBS) is generally safe and well-tolerated. Studies have found that both children and adults can undergo this treatment without major problems, indicating that most people can receive iTBS safely.

While researchers continue to collect long-term safety data, current findings are encouraging. Some studies have examined iTBS for conditions like mild cognitive impairment and stroke, reporting no serious side effects from the treatment.

Overall, for those considering joining a trial for iTBS, current evidence suggests it is safe for most people. However, as with any treatment, individual experiences may differ. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using transcranial magnetic stimulation (TMS), specifically intermittent theta burst stimulation, for concussions because it offers a novel approach to brain recovery. Unlike traditional treatments for concussions, which often involve rest and gradual return to activities, this method uses magnetic fields to stimulate specific brain regions directly. The treatment is tailored to the individual's brain imaging and symptoms, potentially providing a more personalized and effective recovery process. This innovative approach has the potential to speed up recovery times and improve outcomes for those suffering from concussions.

What evidence suggests that transcranial magnetic stimulation is effective for persistent post-concussive symptoms?

Research shows that intermittent theta burst stimulation (iTBS), which participants in this trial will receive, might improve symptoms in people with post-concussion syndrome. Studies have found that iTBS can enhance thinking and movement in individuals with brain injuries. Additionally, research suggests that repetitive transcranial magnetic stimulation (rTMS), which includes iTBS, can boost overall brain function in people with mild memory and thinking problems. This indicates that iTBS could help treat various symptoms of long-lasting post-concussion issues. Although more research is needed, early results offer hope for those dealing with long-term effects after a concussion. ^{2 3 4 6 7}

Who Is on the Research Team?

Bhavani Kashyap, MBBS, PhD

Principal Investigator

HealthPartners Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06398665

Accelerated, Theta-burst Stimulation for the Treatment of ... The current study aims to better understand the efficacy of intermittent theta-burst stimulation (iTBS) treatment in patients diagnosed with post-concussion ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12202228/

Adaptive trial for the treatment of depressive symptoms ... We outline the design of a multisite, double-blind, randomized, sham-controlled trial of aiTBS for the treatment of depressive symptoms in SMs and veterans ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S3050529125000996

Intermittent theta burst stimulation as a potential ... Several studies show that rTMS can enhance overall cognitive functioning of patients with mild cognitive impairment and post-stroke (Chen et al.

4. medrxiv.org medrxiv.org/content/10.1101/2025.10.08.25336734v1.full.pdf

Functional MRI Guided Accelerated Intermittent Theta Burst ... This exploratory study aims to evaluate the feasibility and preliminary ePicacy of an accelerated intermittent theta burst stimulation (iTBS).

5. withpower.com withpower.com/trial/phase-post-concussion-syndrome-3-2024-9c88e

Theta-Burst Stimulation for Post-Concussion Syndrome Research suggests that Intermittent Theta-Burst Stimulation (iTBS) can help improve cognitive and motor functions in conditions like traumatic brain injury and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8617062/

A Systematic Review of the Safety and Tolerability of Theta ... TBS interventions in children may have similar safety, tolerability, and feasibility as compared to adults. However, long-term, follow-up studies of TBS are ...

7. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.123.044892

Intermittent Theta-Burst Stimulation for Stroke: Primary ... This study aimed to compare the efficacy and safety of intermittent theta-burst stimulation (iTBS) to the cerebellum or M1 on balance and motor recovery in ...