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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age22-65
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • intermittent theta burst stimulation
  • placebo intermittent theta burst stimulation

Treatment groups

55 Participants
are divided into 2 treatment groups