Brain Stimulation for Concussion

Overseen By Jody Roberts, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The Mind Research Network

Disqualifiers: Epilepsy, Schizophrenia, Bipolar, others

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

Compensation: Varies

Number of Visits: 30

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new magnetic brain stimulation treatment, known as intermittent theta-burst treatment (iTBS), to help people with persistent symptoms after a concussion. The main goal is to determine if this treatment can reduce symptoms and improve daily life. Participants will undergo MRI scans before and after 30 short sessions to observe brain changes. This trial may suit those who have had a concussion and continue to experience symptoms more than three months later. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for concussion recovery.

Will I have to stop taking my current medications?

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

What prior data suggests that this magnetic brain stimulation is safe for patients with persistent post-concussive symptoms?

Research shows that intermittent theta-burst stimulation (iTBS) is generally safe and well-tolerated in both adults and children. Many studies have explored this treatment for various conditions, such as mild cognitive impairment, without finding major safety issues. Most participants manage the sessions well, with only minor side effects like mild headaches or scalp discomfort reported in some cases.

While researchers continue to study the long-term effects, current evidence indicates that iTBS is safe for short-term use. This aligns with its use in other medical settings, suggesting it could be a promising option for treating ongoing symptoms after a concussion. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for concussion, which often include rest, medication, and physical therapy, intermittent theta-burst stimulation (iTBS) offers a novel approach by using non-invasive brain stimulation to promote recovery. Researchers are excited about iTBS because it targets the brain's neural networks directly, potentially speeding up the healing process. This method is unique because it can be administered quickly and may provide faster symptom relief compared to traditional methods.

What evidence suggests that this new type of magnetic brain stimulation is effective for persistent post-concussive symptoms?

Research has shown that intermittent theta-burst stimulation (iTBS) can improve thinking and memory. In this trial, participants will receive iTBS after a 2-week control waitlist period. For individuals with post-concussion symptoms, iTBS may alleviate these symptoms and enhance daily functioning. Some studies suggest that iTBS can boost overall brain performance, potentially aiding issues like concentration difficulties. Early research also indicates that iTBS positively influences brain activity, making it a potential treatment for concussion-related problems. Although more studies are needed, these early results offer promise for those with ongoing post-concussion symptoms. ^{2 5 6 7 8}

Who Is on the Research Team?

Harm J van der Horn, MD PhD

Principal Investigator

Mind Research Network

Are You a Good Fit for This Trial?

This trial is for adults aged 18-64 who have had a mild traumatic brain injury (mTBI) with symptoms lasting more than 3 months. Participants should have experienced altered mental status or loss of consciousness for up to 30 minutes, and post-traumatic amnesia not exceeding 24 hours after the injury.

Inclusion Criteria

I have had symptoms from an injury for more than 3 months.

I had a mild brain injury with a brief loss of consciousness and memory issues for less than a day.

Exclusion Criteria

History of developmental, neurological (e.g., epilepsy) or serious mental health disorders (e.g., schizophrenia, bipolar disorder) prior to TBI onset

History of a previous substance use disorder except for alcohol, or a currently active substance use disorder (within last 6 months)

Contraindications for MRI (e.g., any implanted ferromagnetic materials, claustrophobia, pregnancy) or iTBS (e.g., history of seizures)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Waitlist

Participants undergo a 2-week control waitlist period before treatment begins

2 weeks

Treatment

Participants receive 30 sessions of intermittent theta-burst stimulation (iTBS) over approximately 4 weeks

4 weeks

30 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3 months

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Intermittent theta-burst treatment (iTBS)

Trial Overview The study tests intermittent theta-burst treatment (iTBS) using a MagPro Transcranial Magnetic Stimulator on patients with persistent concussion symptoms. It involves MRI scans before and after thirty short sessions to assess symptom reduction and improvements in brain function.

How Is the Trial Designed?

Group I: Waitlist-control-treatment-group Experimental Treatment 1 Intervention

After a 2-week control waitlist period, patient receive 30 treatments.

Who Is Running the Clinical Trial?

The Mind Research Network

Lead Sponsor

Trials

27

Recruited

2,300+

University of New Mexico

Collaborator

Trials

393

Recruited

3,526,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12403035/

A randomized controlled study on intermittent theta pulse ... This study evaluates the efficacy and underlying mechanisms of intermittent theta-burst stimulation (iTBS) in improving cognitive function ...

2. 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 ...

3. 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).

4. 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 ...

5. 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.

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. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-025-01625-5

A pilot randomized controlled double-blind trial of intermittent ... This innovative study aims to test the feasibility of iTBS as a cognitive enhancement strategy in MCI.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0166432823000268

Investigation of neurobiological responses to theta burst ... The purpose of this study was to investigate neurobiological effects of one session of intermittent theta burst stimulation (iTBS) to the dorsolateral ...