Brain Stimulation for Post-Concussion Syndrome

Not yet recruiting at 1 trial location

Overseen By Kevin Bickart, MD/PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, Los Angeles

Disqualifiers: Neurologic deficits, Severe mental problems, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals experiencing ongoing issues from a concussion or mild traumatic brain injury, such as headaches, dizziness, or memory problems, which hinder daily activities. The study tests transcranial magnetic stimulation (TMS), a noninvasive method to stimulate brain regions. This personalized brain stimulation involves participants receiving either active TMS or a sham (inactive) version. Researchers aim to determine if this treatment improves brain function and reduces symptoms. Individuals who have experienced a mild traumatic brain injury in the past year with persistent symptoms may be suitable for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to the development of a potentially effective therapy.

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 brain stimulation technique is safe for treating post-concussion syndrome?

Research shows that transcranial magnetic stimulation (TMS) could be a promising treatment for symptoms following a concussion. Studies have found that TMS is generally safe and well-tolerated. For example, research on a similar type of TMS, called intermittent theta-burst stimulation (iTBS), showed it can help with symptoms like depression and PTSD (post-traumatic stress disorder) without causing major side effects. In these studies, many participants felt better, and some even experienced complete symptom relief.

Although researchers are still studying TMS for post-concussion syndrome, its use in other conditions suggests it is safe. Most side effects reported in TMS studies are mild, such as headaches or scalp discomfort, and they usually resolve quickly. Since this trial is in an early stage, researchers are still gathering detailed safety information specific to this condition. However, existing research provides a positive view of the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for post-concussion syndrome?

Researchers are excited about personalized brain stimulation for post-concussion syndrome because it offers a targeted approach that differs from current treatments like medication and cognitive rest. Unlike these standard treatments, which often focus on managing symptoms, personalized brain stimulation uses continuous theta-burst stimulation (cTBS) to directly target specific brain regions mapped for each individual. This method aims to address the underlying brain circuit disruptions, potentially leading to faster and more effective relief. By tailoring the stimulation to each person's unique brain circuitry, this approach could provide a more precise and powerful treatment option for those struggling with persistent post-concussion symptoms.

What evidence suggests that this brain stimulation treatment might be effective for post-concussion syndrome?

Research is exploring a treatment called transcranial magnetic stimulation (TMS) for post-concussion symptoms. Some early studies have shown mixed results, with some indicating that a specific type of TMS, called theta-burst stimulation, might not aid brain recovery after a mild head injury. However, this trial will provide participants with personalized brain stimulation, which may improve brain connections and reduce symptoms like dizziness and headaches by targeting specific brain areas. This noninvasive treatment does not involve surgery or medication and is tailored to each person's brain. More research is needed to confirm its effectiveness, but it shows promise as a new therapy for those dealing with post-concussion syndrome. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for people aged 18-65 who've had a mild traumatic brain injury in the last year and are struggling with symptoms like dizziness, headaches, or memory issues. They should have significant post-concussive symptoms but no severe medical conditions, drug abuse history, previous TMS therapy, or MRI contraindications like pacemakers.

Inclusion Criteria

I score 20 or more on the Rivermead Post-Concussion Symptoms test.

I have had a mild brain injury in the last year.

I was between 18 and 65 years old when I had my mild traumatic brain injury.

Exclusion Criteria

I do not have severe health issues that could interfere with the study.

I have measurable issues with my nervous system.

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

1 visit (in-person)

Baseline Assessment

Baseline symptom assessments and magnetic resonance imaging (MRI)

1 day

1 visit (in-person)

Treatment

Participants receive 10 days of transcranial magnetic stimulation (TMS) administration

2 weeks

10 visits (in-person)

Post-Treatment Assessment

Post-treatment symptom assessments and MRIs

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Brain Stimulation

Trial Overview The study tests personalized transcranial magnetic stimulation (TMS) to treat chronic concussion symptoms. Participants will visit UCLA for baseline assessments and MRIs, receive TMS over ten sessions, and then have follow-up assessments. Two-thirds will get active TMS believed to change brain function; one-third will get sham TMS.

How Is the Trial Designed?

Group I: Active continuous theta-burst stimulation (cTBS) plus exposure Experimental Treatment 2 Interventions

10 days of active, continuous theta-burst stimulation (cTBS) will be delivered to a personalized region of the ventromedial prefrontal cortex (vmPFC) based on baseline brain circuit mapping for each individual participant.

Group II: Active Comparator continuous theta-burst stimulation (cTBS) plus exposure Active Control 2 Interventions

10 days of active, continuous theta-burst stimulation (cTBS) will be delivered to a personalized region of the ventromedial prefrontal cortex (vmPFC) based on baseline brain circuit mapping for each individual participant.

Group III: Inactive/Sham continuous theta-burst stimulation (cTBS) plus exposure Placebo Group 2 Interventions

10 days of inactive, or sham, continuous theta-burst stimulation (cTBS) will be delivered to a personalized region of the ventromedial prefrontal cortex (vmPFC) based on baseline brain circuit mapping for each individual participant.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

Repetitive transcranial magnetic stimulation (rTMS) shows promising preliminary results in treating post-concussive symptoms, particularly for depression and headaches, based on a systematic review of 11 studies involving small pilot samples.

While rTMS demonstrated positive outcomes in some studies, the overall methodological diversity and small sample sizes highlight the need for further research to confirm its efficacy in larger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation for the Treatment of Concussion: A Systematic Review. Mollica, A., Safavifar, F., Fralick, M., et al.[2022]

Transcranial direct current stimulation (tDCS) showed promising early efficacy in improving working memory performance in youth with cognitive persistent post-concussion symptoms, particularly on a dual task working memory test.

The study found that participants tolerated tDCS well, with the active tDCS group reporting fewer strong symptoms compared to the sham group, suggesting it could be a feasible adjunct to behavioral therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of transcranial direct current stimulation on cognitive performance in youth with persistent cognitive symptoms following concussion: a controlled pilot study. Quinn de Launay, K., Cheung, ST., Riggs, L., et al.[2022]

A study involving 25 patients aged 12-20 with post-concussion syndrome showed that a multimodal physical therapy approach significantly reduced symptoms, as indicated by a decrease in the Post-Concussion Symptom Scale scores from an average of 18.2 to 9.1 after treatment.

The therapy also improved physical performance, with a 23% increase in maximum symptom-free heart rate during exercise and a 52% reduction in balance errors, demonstrating both safety and efficacy in managing post-concussion symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal impairment-based physical therapy for the treatment of patients with post-concussion syndrome: A retrospective analysis on safety and feasibility. Grabowski, P., Wilson, J., Walker, A., et al.[2022]

A personalized rTMS (PrTMS) protocol was tested on 185 patients with persistent concussion symptoms over approximately 6 weeks, showing improvements in concussion-related indices and normalization of EEG measures, suggesting potential changes in neurotransmitter and cognitive function.

While the results are promising, indicating that PrTMS may be a viable treatment option for concussion, the study lacked a control group and did not account for several variables, highlighting the need for further research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Observations of Personalized Repetitive Magnetic Stimulation (PrTMS) Guided by EEG Spectra for Concussion. Makale, MT., Nybo, C., Keifer, J., et al.[2023]

Brain stimulation techniques, particularly transcranial direct current stimulation, show promise in promoting recovery from traumatic brain injury (TBI), especially in chronic phases, but evidence for acute phase efficacy and safety is still limited.

Most current brain stimulation interventions are non-targeted and lack sufficient clinical trials, highlighting the need for larger, well-designed studies to better understand their potential benefits in enhancing neuroplasticity and functional outcomes after TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical utility of brain stimulation modalities following traumatic brain injury: current evidence. Li, S., Zaninotto, AL., Neville, IS., et al.[2022]

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/PMC12230962/

Personalized brain functional sectors guided theta burst ... Additionally, 50% of patients may develop treatment-resistant depression (TRD) after trying various interventions but were ineffective.

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

Theta-Burst Stimulation for Post-Concussion Syndrome The results indicate that iTBS may not be an effective intervention for enhancing brain recovery after mTBI, suggesting that further research is needed to ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT07211919

Study Details | NCT07211919 | Accelerated Transcranial ... This study looks at the effects of accelerated intermittent theta burst stimulation (aiTBS) on patients with chronic and acute post-concussion ...

6. cognitivefxusa.com cognitivefxusa.com/blog/theta-burst-stimulation-tms-treatment

Theta Burst Stimulation TMS Treatment: A Patient's Guide Results showed that 50% of participants treated with iTBS experienced improvements in their depressive symptoms, and 33% achieved remission.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0165178123004833

Effects of intermittent theta-burst transcranial magnetic ... ITBS, with a shorter treatment duration, can effectively improve the symptoms of PTSD, with no significant difference in effect from that of rTMS.