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

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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?

Research Team

Harm J van der Horn, MD PhD

Principal Investigator

Mind Research Network

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+