Active — Not RecruitingNot Applicable

Brain Stimulation for Concussion

United States15 participantsStarted 2023-10-30

Plain-language summary

The goal of this clinical trial is to test a new type of magnetic brain stimulation in patients with persistent post-concussive symptoms. Participants will undergo detailed MRI scans before and after 30 treatment sessions (of 3-10 minutes each). The main questions the study aims to answer are: * Will this new type of treatment result in fewer symptoms and better daily functioning? * What are the effects of this treatment on brain functioning?

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult age at inclusion 18-64 years. * mTBI as defined by an altered mental status at time of injury, and LOC of max 30 min, GCS 13-15 (after 30 min), and PTA max 24 hrs. * Persistent post-traumatic symptoms in chronic phase (\>3 months post-injury). 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is no longer actively recruiting — does that mean it's too late for me to participate, or is it worth contacting the research team to see if there's any possibility of joining?
2Since this study involves transcranial magnetic stimulation (TMS) alongside MRI and neuropsychological tests, can you help me understand what the TMS procedure actually involves and whether it carries any specific risks for someone with my concussion history?
3The trial is measuring neurometabolites related to neuronal function and inflammation — what does that mean for what researchers are trying to learn, and how far are we from knowing whether TMS actually helps with post-concussion syndrome?
4This trial is listed as Phase NA, which I understand can apply to device or procedure studies — how does that affect what's already known about the safety and effectiveness of TMS for post-concussion symptoms compared to more standard treatments?
5Given that I'm dealing with post-concussion syndrome, would you recommend looking into a study like this, or are there standard care options I should try first before considering an experimental approach?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Post-concussive symptoms

Timeframe: Post-treatment (after completion of all sessions, at ~4 weeks), and at 3 months after start of the study for the individual participant. Data will be reported at the conclusion of the study for all participants.

Neurometabolite diffusion related to neuronal function and inflammation

Timeframe: Post-treatment for the individual participant (~4 weeks). Data will be reported at the conclusion of the study for all participants.

Trial details

NCT IDNCT05889117

SponsorThe Mind Research Network

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-01

View on ClinicalTrials.gov More Transcranial Magnetic Stimulation trials