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Behavioural Intervention

iTBS for Concussion-Related Impulsivity and Suicidal Thoughts

Phase 1

Waitlist Available

Led By Alexandra L Aaronson, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up rated at baseline, study midpoint (at the end of week 1) and study completion, approximately 2 weeks after study begins.

Awards & highlights

Study Summary

This trial studies a new treatment for impulsivity, suicidal thoughts, and functional impairments after a mild traumatic brain injury. Researchers use a high-powered magnetic pulse, called iTBS, to activate certain cells in the brain to try and improve symptoms.

Who is the study for?

This trial is for veterans aged 22-65 with mild traumatic brain injury (mTBI) who experience impulsivity and suicidal thoughts. Participants must have a history of impulsivity or score high on an urgency scale, and have had recent suicidal ideation. They cannot join if they have epilepsy, MRI contraindications like claustrophobia or metal implants, severe TBI history, unstable medical conditions, recent major surgery, pregnancy, active substance abuse issues, non-traumatic neuroinjury history or current psychosis.Check my eligibility

What is being tested?

The study tests intermittent theta burst stimulation (iTBS), which uses magnetic pulses to activate brain cells in hopes of improving symptoms from mTBI such as impulsivity and suicidal thoughts. While iTBS is FDA approved for other uses, it's not yet approved for these specific symptoms when applied to the front of the head.See study design

What are the potential side effects?

Potential side effects are not detailed in the provided information but may include discomfort at the stimulation site or headaches due to magnetic pulse exposure. Since iTBS involves brain cell activation there could be risks related to changes in mood or cognition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ rated at baseline, study midpoint (at the end of week 1) and study completion, approximately 2 weeks after study begins

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~rated at baseline, study midpoint (at the end of week 1) and study completion, approximately 2 weeks after study begins

This trial's timeline: 3 weeks for screening, Varies for treatment, and rated at baseline, study midpoint (at the end of week 1) and study completion, approximately 2 weeks after study begins for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Social and Occupational Functioning Assessment Scale (SOFAS)

Session Completion Rate

Secondary outcome measures

Change in Columbia Suicide severity rating scale (C-SSRS)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: active iTBSActive Control1 Intervention

Subjects receiving active iTBS treatment

Group II: placebo iTBSPlacebo Group1 Intervention

Subjects receiving placebo (sham) iTBS treatment

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,548 Total Patients Enrolled

Alexandra L Aaronson, MDPrincipal InvestigatorEdward Hines Jr. VA Hospital, Hines, IL

Media Library

Intermittent Theta Burst Stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05647044 — Phase 1

Concussion Research Study Groups: active iTBS, placebo iTBS

Concussion Clinical Trial 2023: Intermittent Theta Burst Stimulation Highlights & Side Effects. Trial Name: NCT05647044 — Phase 1

Intermittent Theta Burst Stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05647044 — Phase 1

Frequently Asked Questions

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

Is the eligibility criteria for this clinical trial inclusive of those over four decades old?

"This clinical trial has strict age limits specifying that only patients aged between 22 to 65 may participate. In contrast, there are 204 studies available for minors and 785 options for seniors."

Answered by AI

How would you rate the security of active iTBS for individuals?

"Due to the limited data available, active iTBS is judged to be very safe by our team at Power and has been rated a 1 on their safety scale."

Answered by AI

Are participants being recruited for this clinical endeavor at present?

"This study, posted on April 1st 2023 and recently edited on December 2nd 2022 is not presently enrolling participants. Nevertheless, there are currently 1047 other trials recruiting patients at this time."

Answered by AI

What is the eligibility criteria for participating in this medical experiment?

"This research aims to enrol 55 individuals, aged 22-65, who are currently experiencing suicidal thoughts. Those involved need to be fluent in English and properly register for mTBI using the SACA scale as well as have a C-SSRS score of over 1 within last month. Moreover, they must display evidence of impulsivity either through their medical records or by scoring higher than 20 on UPPS-P negative urgency subscale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Frontal iTBS for Impulsivity and Suicidal Ideation in Veterans With Mild Traumatic Brain Injury

2024. "Frontal iTBS for Impulsivity and Suicidal Ideation in Veterans With Mild Traumatic Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05647044.

All > Mental Illness > Traumatic Brain Injury