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NCT05647044 · ClinicalTrials.gov registry record · Phase 1
Frontal iTBS for Impulsivity and Suicidal Ideation in Veterans With Mild Traumatic Brain Injury
A Phase 1 study of Suicidal Ideation and Mild Traumatic Brain Injury, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT05647044: Recruiting Phase 1 study of Suicidal Ideation and Mild Traumatic Brain Injury, sponsored by VA Office of Research and Development.
NCT05647044 is a Phase 1 study of Suicidal Ideation and Mild Traumatic Brain Injury that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 55 participants, below the 267-participant average among 84 other Suicidal Ideation trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05647044, a Phase 1 study of Suicidal Ideation and Mild Traumatic Brain Injury, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators hope to develop a treatment for suicidal ideation (SI), impulsivity and functional impairments (such as difficulties in social and work settings) that occur after a mild traumatic brain injury (mTBI). These conditions have been shown to be linked. The investigators are using a high-powered magnetic pulse, called intermittent theta burst stimulation (iTBS) applied to the head to see if it can improve these symptoms. The high-powered magnetic pulse causes certain cells in the brain to activate, which seems to strengthen connections between parts of the brain. The purpose of this research is to gather early information on the safety and effectiveness of iTBS provided to the front of the head for impulsivity, SI and functional deficits after mTBI. The investigators plan to use the data collected in this study to develop larger studies in the future. iTBS is FDA approved, but not for these specific symptoms, or in the specific location the investigators are placing it. The investigators are testing to see if its effective for the above conditions when applied to the front of the head.
Primary Outcome
For establish intervention feasibility and tolerability, the study will tract the number of completed iTBS sessions and compute completion percentage rates for each participant.
Conditions Studied
Interventions
- DEVICE intermittent theta burst stimulation
- DEVICE placebo intermittent theta burst stimulation
Study Locations (1)
Illinois
- Edward Hines Jr. VA Hospital, Hines, IL - Hines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2024-05-20 |
| Est. Completion | 2028-03-31 |
| Phase | Phase 1 |
What NCT05647044 shows while recruiting
NCT05647044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 267-participant average among 84 other Suicidal Ideation trials with a reported enrollment target (79% lower).
The record links to 3 conditions, with Suicidal Ideation appearing as the primary indexed condition, and to 2 interventions - of which intermittent theta burst stimulation is the first listed.
NCT05647044 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT05647044 about?
NCT05647044 is a clinical study titled "Frontal iTBS for Impulsivity and Suicidal Ideation in Veterans With Mild Traumatic Brain Injury". The investigators hope to develop a treatment for suicidal ideation (SI), impulsivity and functional impairments (such as difficulties in social and work settings) that occur after a mild traumatic brain injury (mTBI). These conditions have been shown to be linked. The investigators are using a high...
What is the current status of trial NCT05647044?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2024-05-20. Estimated completion is 2028-03-31.
What conditions does trial NCT05647044 study?
This clinical trial studies the following conditions: Suicidal Ideation, Mild Traumatic Brain Injury, Impulsivity.
What interventions are being tested in trial NCT05647044?
The interventions under investigation include: intermittent theta burst stimulation (DEVICE), placebo intermittent theta burst stimulation (DEVICE).
Who is sponsoring clinical trial NCT05647044?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05647044 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05647044's enrollment target sits among peer trials
55 64th of 84 higher than 21 of 84 other Suicidal Ideation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Suicidal Ideation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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