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New treatment option for Mild Traumatic Brain Injury
Official title Frontal iTBS for Impulsivity and Suicidal Ideation in Veterans With Mild Traumatic Brain Injury
ClinicalTrials.gov ID: NCT05647044
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 65
You may be able to join if
- 22-65 years of age
- can read and speak English
- meets criteria for mTBI according to the symptom attribution and classification (SACA) scale
- Has a C-SSRS (suicidal ideation rating) of \>1 within the past month
- Has a history of impulsivity documented in the medical chart and/or a score of \>20 on the UPPS-P negative urgency impulsivity subscale
You likely can't join if
- Has contraindications to iTBS (i.e., epilepsy)
- Has contraindications to MRI (i.e., claustrophobia, ferromagnetic metal implants)
- Has an active substance use disorder per the DSM-V criteria
- Has a history of moderate to severe TBI
- Has a history of non-traumatic neuroinjury (i.e., stroke, neurosurgery, hemorrhage)
- Has a history of, or current psychosis not due to an external cause
See the full eligibility criteria
- 22-65 years of age
- can read and speak English
- meets criteria for mTBI according to the symptom attribution and classification (SACA) scale
- Has a C-SSRS (suicidal ideation rating) of \>1 within the past month
- Has a history of impulsivity documented in the medical chart and/or a score of \>20 on the UPPS-P negative urgency impulsivity subscale
- Has contraindications to iTBS (i.e., epilepsy)
- Has contraindications to MRI (i.e., claustrophobia, ferromagnetic metal implants)
- Has an active substance use disorder per the DSM-V criteria
- Has a history of moderate to severe TBI
- Has a history of non-traumatic neuroinjury (i.e., stroke, neurosurgery, hemorrhage)
- Has a history of, or current psychosis not due to an external cause
- Is pregnant
- Has an active, unstable medical condition
- Is within 12 weeks of a major surgery or operation
- Is within 1 year of TBI
The study team makes the final eligibility decision.
Where it's taking place
- Hines, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hines, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.