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 range18 Years – 64 Years

SexALL

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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).

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