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Brain Stimulation

Waitlist-control-treatment-group for Traumatic Brain Injury

N/A

Recruiting

Led By Harm J van der Horn, MD PhD

Research Sponsored by The Mind Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

Study Summary

This trial aims to test a new magnetic brain stimulation treatment for patients with ongoing symptoms after a concussion. Participants will have MRI scans before and after 30 short treatment sessions. The study wants to find out

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, headache, lightheadedness, or seizures; however, these are generally rare with transcranial magnetic stimulation procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Neurometabolite diffusion related to neuronal function and inflammation

Post-concussive symptoms

Secondary outcome measures

Brain network functioning

Cognitive functioning

Functional outcome

Trial Design

1Treatment groups

Experimental Treatment

Group I: Waitlist-control-treatment-groupExperimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of New MexicoOTHER

372 Previous Clinical Trials

3,528,774 Total Patients Enrolled

The Mind Research NetworkLead Sponsor

26 Previous Clinical Trials

2,485 Total Patients Enrolled

Harm J van der Horn, MD PhDPrincipal InvestigatorMind Research Network

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals who are 18 years of age or older eligible to participate in this research study?

"Individuals aged 18 and older but below 64 are eligible for recruitment in this research."

Answered by AI

Which individuals meet the eligibility criteria to participate in this study?

"To be eligible for enrollment in this research study, individuals must exhibit symptoms consistent with post-concussion syndrome and fall within the age range of 18 to 64 years. The study has capacity for a total of 15 participants."

Answered by AI

What is the upper limit of participant enrollment for this medical study?

"Indeed, the details available on clinicaltrials.gov highlight that this research project is actively seeking volunteers. The trial was first listed on October 30th, 2023, and underwent its most recent update on March 12th, 2024. As of now, they are aiming to recruit a total of 15 participants from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Brain Stimulation for Concussion

2023. "Brain Stimulation for Concussion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05889117.

All > Concussion > Albuquerque