Mild Traumatic Brain InjuryPhase 1NCT05647044
Frontal iTBS for Impulsivity and Suicidal Ideation in Veterans With Mild Traumatic Brain Injury
A Phase 1 study testing intermittent theta burst stimulation in people with Mild Traumatic Brain Injury and Suicidal Ideation, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Mild Traumatic Brain Injury, Suicidal Ideation, Impulsivity
- What is being tested?
- intermittent theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2024to 31 Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Is pregnant
- Has an active, unstable medical condition
- Is within 12 weeks of a major surgery or operation
- Is within 1 year of TBI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
William Wolf, PhD, 708-202-5689, William.Wolf@va.gov
Gabriella G Amador, Gabriella.Amador@va.gov
About this study
Official title: Neuromodulation for Impulsivity and Suicidality in Veterans With Mild Traumatic Brain Injury and Common Co-occurring Mental Health Conditions
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.
Read the detailed description
Individuals with mild traumatic brain injury (mTBI) are at increased risk of dying by suicide compared to those without - both among Veteran and civilian populations. 22% of Veterans with mTBI report struggling with suicidal ideation (SI). Despite this, there are no effective evidence-based treatments for co-occurring mTBI and SI. Deficits in social and occupational functioning, which often follow mTBI, are strongly related to suicidal ideation (SI) and improvements in these areas are known to lessen SI. Thus, improving function for those with mTBI and SI is of great potential significance. The impulsivity that Veterans with mTBI exhibit is referred to as "negative urgency impulsivity". It often involves aggressive and self-harming behaviors, which impede societal re-integration and rehabilitation. Prior studies indicate negative urgency impulsivity is: (1) a common TBI sequela and (2) a risk factor for SI. Previous studies have also indicated individuals with TBI, SI and negative urgency impulsivity had reduced right-sided ventromedial prefrontal cortex (VMPFC) volume compared to Veterans without these conditions. The VMPFC plays a key role in controlling impulsive limbic responses. These findings are consistent with published reports suggesting individuals with reduced VMPFC volume are more likely to (a) have SI and (b) behave impulsively.
Transcranial magnetic stimulation (TMS) holds significant therapeutic promise for post-mTBI SI, impulsivity and functional deficits. TMS induces neuroplasticity, leading to changes that have the potential to improve neurorehabilitation outcomes. TMS is effective for treating post-TBI depression when administered to the dorsolateral prefrontal cortex. Intermittent theta burst stimulation (iTBS) is a "second generation" form of TMS that is delivered more rapidly. It has been proposed that frontal pole TMS could directly strengthen connections throughout the prefrontal cortex, including the VMPFC, thereby dampening limbic system activity. Such a TMS treatment strategy could be used to treat post-mTBI impulsivity and SI, ultimately allowing Veterans to regain functioning. It is not know which Veterans would benefit most from this treatment; examining neural connectivity changes before and after iTBS could determine who would respond to frontal pole iTBS and why.
The investigators will conduct a randomized, double-blinded frontal iTBS pilot clinical trial for Veterans with mTBI, impulsivity and SI. As this is a novel treatment approach for this population, this project will focus on testing the safety, feasibility and tolerability of frontal pole iTBS. To inform future research, this project will determine the preliminary effects of iTBS on functioning, negative urgency impulsivity and SI among the pilot sample. This project will also inform future research by examining the relationships between the functional neural connectivity of the VMPFC to the limbic system and how this is affected by iTBS using resting state functional connectivity (rsFC) neuroimaging data, pre- and post-iTBS.
- Conditions
- Mild Traumatic Brain Injury, Suicidal Ideation, Impulsivity
- Being tested
- intermittent theta burst stimulation, placebo intermittent theta burst stimulation
- Keywords
- brain concussion, brain injuries, traumatic, brain injuries, self-injurious behavior, suicide, attempted, suicide, impulsive behavior, risk-taking, brain diseases, craniocerebral trauma, social problems, mental disorders
- Medical subject headings
- Brain Concussion, Suicidal Ideation, Impulsive Behavior, Brain Injuries, Traumatic, Brain Injuries, Self-Injurious Behavior, Suicide, Attempted, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent theta burst stimulationDevice
Also called iTBS
intermittent 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 stimulationDevice
Also called placebo iTBS
intermittent 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.
| Study group | Role | What they receive |
|---|---|---|
| active iTBS | Active comparator | Subjects receiving active iTBS treatment Receives: Device: intermittent theta burst stimulation |
| placebo iTBS | Placebo comparator | Subjects receiving placebo (sham) iTBS treatment Receives: Device: placebo intermittent theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Endpoint - after last iTBS session, approximately 2 weeks
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.
Measured: Rated at baseline, study midpoint (at the end of week 1) and study completion, approximately 2 weeks after study begins
Secondary 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.
Measured: Rated at baseline, study midpoint (at the end of week 1) and study completion, approximately 2 weeks after study begins.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start20 May 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P and Magpro C-B60
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alexandra L Aaronson, MD, Principal investigator, Edward Hines Jr. VA Hospital, Hines, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647044
- Sponsor's protocol ID
- D4298-W
- Status last verified
- Apr 2026
- First submitted
- 15 Nov 2022
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: A de-identified data set will be created and shared. Final data sets will be made available as per Hines VA Hospital local policy for long term storage and access until enterprise-level resources become available. These data will be available upon request by researchers and scientists in accordance with federal guidelines and Hines local policy. The data provided will be sufficient for anyone to perform analogous or supplemental analyses that would permit validation of the analysis and results. The sharing of data will enable others to evaluate the data and to validate and interpret the data independently. In order to ensure that replication is possible and transparency, statistical code complementary to datasets will be made available through the Federal Interagency Traumatic Brain Injury Research Informatics System
Publications
Bernanke A, Hasley R, Sabetfakhri N, de Wit H, Smith BM, Wang L, Brenner LA, Hanlon C, Philip NS, Ajilore O, Herrold A, Aaronson A. Frontal Pole Neuromodulation for Impulsivity and Suicidality in Veterans With Mild Traumatic Brain Injury and Common Co-Occurring Mental Health Conditions: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Dec 13;13:e58206. doi: 10.2196/58206.
PubMed 39671573
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation for Impulsivity and Suicidality in Veterans With Mild Traumatic Brain Injury and Common Co-occurring Mental Health Conditions
- ClinicalTrials.gov ID
- NCT05647044
- Acronym / sponsor ID
- D4298-W
- Conditions
- Mild Traumatic Brain Injury, Suicidal Ideation, Impulsivity
- Keywords
- brain concussion, brain injuries, traumatic, brain injuries, self-injurious behavior, suicide, attempted, suicide, impulsive behavior, risk-taking
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 20 May 2024 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Individuals with mild traumatic brain injury (mTBI) are at increased risk of dying by suicide compared to those without - both among Veteran and civilian populations. 22% of Veterans with mTBI report struggling with suicidal ideation (SI). Despite this, there are no effective evidence-based treatments for co-occurring mTBI and SI. Deficits in social and occupational functioning, which often follow mTBI, are strongly related to suicidal ideation (SI) and improvements in these areas are known to lessen SI. Thus, improving function for those with mTBI and SI is of great potential significance. The impulsivity that Veterans with mTBI exhibit is referred to as "negative urgency impulsivity". It often involves aggressive and self-harming behaviors, which impede societal re-integration and rehabilitation. Prior studies indicate negative urgency impulsivity is: (1) a common TBI sequela and (2) a risk factor for SI. Previous studies have also indicated individuals with TBI, SI and negative urgency impulsivity had reduced right-sided ventromedial prefrontal cortex (VMPFC) volume compared to Veterans without these conditions. The VMPFC plays a key role in controlling impulsive limbic responses. These findings are consistent with published reports suggesting individuals with reduced VMPFC volume are more likely to (a) have SI and (b) behave impulsively.
Transcranial magnetic stimulation (TMS) holds significant therapeutic promise for post-mTBI SI, impulsivity and functional deficits. TMS induces neuroplasticity, leading to changes that have the potential to improve neurorehabilitation outcomes. TMS is effective for treating post-TBI depression when administered to the dorsolateral prefrontal cortex. Intermittent theta burst stimulation (iTBS) is a "second generation" form of TMS that is delivered more rapidly. It has been proposed that frontal pole TMS could directly strengthen connections throughout the prefrontal cortex, including the VMPFC, thereby dampening limbic system activity. Such a TMS treatment strategy could be used to treat post-mTBI impulsivity and SI, ultimately allowing Veterans to regain functioning. It is not know which Veterans would benefit most from this treatment; examining neural connectivity changes before and after iTBS could determine who would respond to frontal pole iTBS and why.
The investigators will conduct a randomized, double-blinded frontal iTBS pilot clinical trial for Veterans with mTBI, impulsivity and SI. As this is a novel treatment approach for this population, this project will focus on testing the safety, feasibility and tolerability of frontal pole iTBS. To inform future research, this project will determine the preliminary effects of iTBS on functioning, negative urgency impulsivity and SI among the pilot sample. This project will also inform future research by examining the relationships between the functional neural connectivity of the VMPFC to the limbic system and how this is affected by iTBS using resting state functional connectivity (rsFC) neuroimaging data, pre- and post-iTBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P and Magpro C-B60
| Arm | Type | Receives |
|---|---|---|
| active iTBS | Active comparator | Device: intermittent theta burst stimulationSubjects receiving active iTBS treatment |
| placebo iTBS | Placebo comparator | Device: placebo intermittent theta burst stimulationSubjects receiving placebo (sham) iTBS treatment |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intermittent theta burst stimulationAlso: iTBSintermittent 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. | Device | active iTBS |
| placebo intermittent theta burst stimulationAlso: placebo iTBSintermittent 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. | Device | placebo iTBS |
Primary outcome
Session Completion Rate
Time frame: Endpoint - after last iTBS session, approximately 2 weeks
For establish intervention feasibility and tolerability, the study will tract the number of completed iTBS sessions and compute completion percentage rates for each participant.
Change in Social and Occupational Functioning Assessment Scale (SOFAS)
Time frame: Rated at baseline, study midpoint (at the end of week 1) and study completion, approximately 2 weeks after study begins
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.
1 secondary outcome
Change in Columbia Suicide severity rating scale (C-SSRS)
Time frame: Rated at baseline, study midpoint (at the end of week 1) and study completion, approximately 2 weeks after study begins.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Derived from this study: PubMed 39671573Bernanke A, Hasley R, Sabetfakhri N, de Wit H, Smith BM, Wang L, Brenner LA, Hanlon C, Philip NS, Ajilore O, Herrold A, Aaronson A. Frontal Pole Neuromodulation for Impulsivity and Suicidality in Veterans With Mild Traumatic Brain Injury and Common Co-Occurring Mental Health Conditions: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Dec 13;13:e58206. doi: 10.2196/58206.
- Individual participant dataSharing planned: Yes. A de-identified data set will be created and shared. Final data sets will be made available as per Hines VA Hospital local policy for long term storage and access until enterprise-level resources become available. These data will be available upon request by researchers and scientists in accordance with federal guidelines and Hines local policy. The data provided will be sufficient for anyone to perform analogous or supplemental analyses that would permit validation of the analysis and results. The sharing of data will enable others to evaluate the data and to validate and interpret the data independently. In order to ensure that replication is possible and transparency, statistical code complementary to datasets will be made available through the Federal Interagency Traumatic Brain Injury Research Informatics System
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandra L Aaronson, MD principal investigator
Edward Hines Jr. VA Hospital, Hines, IL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing intermittent theta burst stimulation in people with Mild Traumatic Brain Injury and Suicidal Ideation, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra L Aaronson, MD ((708) 202-8387, Alexandra.Aaronson@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Session Completion Rate (time frame: Endpoint - after last iTBS session, approximately 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05647044, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.