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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 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.

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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.

Conditions Studied

Suicidal Ideation Mild Traumatic Brain Injury Impulsivity

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

FieldValue
Enrollment Target 55 participants
Start Date 2024-05-20
Est. Completion 2028-03-31
Phase Phase 1

Sponsor

VA Office of Research and Development

1,668 total trials

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What the Registry Record Tells You About NCT05647044

The ClinicalTrials.gov registry entry for NCT05647044 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 267-participant average among 84 other Suicidal Ideation trials with a reported enrollment target (79% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.