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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
intermittent theta burst stimulation
Deviceintermittent theta burst stimulation (iTBS) will be delivered with the Magventure MagProX100 with MagOption stimulation and Magpro Cool Coil B65 A/P. The Magpro Cool Coil B65 A/P can be switched to active or placebo. The Magventure C-B60 coil will be used to deliver single TMS pulses for motor threshold determination.
placebo intermittent theta burst stimulation
Deviceintermittent theta burst stimulation (iTBS) will be delivered with the Magventure MagProX100 with MagOption stimulation and Magpro Cool Coil B65 A/P. The Magpro Cool Coil B65 A/P can be switched to active or placebo. The Magventure C-B60 coil will be used to deliver single TMS pulses for motor threshold determination.
Treatment groups
55 Participants
are divided into 2 treatment groupsGroup A: active iTBSActive comparator 1 intervention
Group B: placebo iTBSPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Session Completion Rate
For establish intervention feasibility and tolerability, the study will tract the number of completed iTBS sessions and compute completion percentage rates for each participant.
Time frame
Endpoint - after last iTBS session, approximately 2 weeks2
Change in Social and Occupational Functioning Assessment Scale (SOFAS)
The Social and Occupational Functioning Assessment scale is a rating, given by a trained medical provider, of an individual's ability to perform basic functioning (such as hygiene, maintaining a job, having social relationships). The scale is from 10, meaning unable to function without harming self or others, to 100, meaning superior functioning in all areas. The investigators will be assessing this at subject's baseline, after 1 week of treatment (5 treatment sessions, at the end of week 1) and at study completion (approximately 2 weeks after study starts) to see if there is a change over time in this measure.
Time frame
Rated at baseline, study midpoint (at the end of week 1) and study completion, approximately 2 weeks after study beginsSecondary outcomes
1
Change in Columbia Suicide severity rating scale (C-SSRS)
The C-SSRS is a short questionnaire addressing any recent suicidal thoughts or behaviors that have occurred. A score of 0 means there have been no suicidal thoughts or behaviors, anything above a 0 means some element of suicidality has been experienced by the test-taker. The investigators will be assessing this at subject's baseline, after 1 week of treatment (5 treatment sessions, at the end of week 1), and at study completion (approximately 2 weeks after study starts) to see if there is a change over time in this measure.
Time frame
Rated at baseline, study midpoint (at the end of week 1) and study completion, approximately 2 weeks after study begins.Sponsors and contacts
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Source ClinicalTrials.gov