Search citation statements
Paper Sections
Citation Types
Year Published
Publication Types
Relationship
Authors
Journals
Background Suicide remains a leading cause of death among veterans in the United States, and mild traumatic brain injury (mTBI) increases the risk of suicidal ideation (SI) and suicide attempts (SAs). mTBI worsens impulsivity and contributes to poor social and occupational functioning, which further increases the risk of SI and SAs. Repetitive transcranial magnetic stimulation is a neuromodulatory treatment approach that induces neuroplasticity, potentially repairing neurodamage. Intermittent theta burst stimulation (iTBS) is a second-generation form of transcranial magnetic stimulation that is safe, shorter in duration, displays a minimal side effect profile and is a promising treatment approach for impulsivity in mTBI. Our novel proposed treatment protocol uses frontal pole iTBS to target the ventromedial prefrontal cortex, which may reduce impulsivity by strengthening functional connectivity between the limbic system and frontal cortex, allowing for improved top-down control of impulsive reactions, including SI and SAs. Objective The objectives of this study are to (1) develop an iTBS intervention for veterans with mTBI, impulsivity, and SI; (2) assess the feasibility and tolerability of the intervention; and (3) gather preliminary clinical outcome data on SI, impulsivity, and functions that will guide future studies. Methods This is a pilot, double-blinded, randomized controlled trial. In developing this protocol, we referenced the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. We will enroll 56 participants (28 active iTBS and 28 sham iTBS). The iTBS intervention will be performed daily, 5 days a week, for 2 weeks. We will collect 10 validated, psychometric, quantitative outcome measures before, during, and after the intervention. Measures included will assess functioning, impulsivity, suicidality, posttraumatic stress disorder, and depressive symptoms. We will collect qualitative data through semistructured interviews to elicit feedback on the participants’ experiences and symptoms. We will perform quantitative and qualitative analyses to (1) assess the feasibility, tolerability, and acceptability of the treatment; (2) gather advanced neuroimaging data to assess neural changes elicited by treatment; and (3) assess improvements in outcome measures of impulsivity and suicidality in veterans with mTBI. Results This study protocol was approved by the Edward Hines, Jr. VA Hospital Institutional Review Board (Hines IRB number 14-003). This novel treatment is a 5-year research project (April 1, 2023, to March 31, 2028) funded by the Veterans Administration Rehabilitation Research and Development service (CDA2 award IK2 RX002938). Study results will be disseminated at or before the project’s end date in March 2028. Conclusions We will provide preliminary evidence of the safety, feasibility, and acceptability of a novel frontal pole iTBS treatment for mTBI, impulsivity, SI and SAs, and functional deficits. Trial Registration ClinicalTrials.gov NCT05647044; https://clinicaltrials.gov/study/NCT05647044 International Registered Report Identifier (IRRID) PRR1-10.2196/58206
Background Suicide remains a leading cause of death among veterans in the United States, and mild traumatic brain injury (mTBI) increases the risk of suicidal ideation (SI) and suicide attempts (SAs). mTBI worsens impulsivity and contributes to poor social and occupational functioning, which further increases the risk of SI and SAs. Repetitive transcranial magnetic stimulation is a neuromodulatory treatment approach that induces neuroplasticity, potentially repairing neurodamage. Intermittent theta burst stimulation (iTBS) is a second-generation form of transcranial magnetic stimulation that is safe, shorter in duration, displays a minimal side effect profile and is a promising treatment approach for impulsivity in mTBI. Our novel proposed treatment protocol uses frontal pole iTBS to target the ventromedial prefrontal cortex, which may reduce impulsivity by strengthening functional connectivity between the limbic system and frontal cortex, allowing for improved top-down control of impulsive reactions, including SI and SAs. Objective The objectives of this study are to (1) develop an iTBS intervention for veterans with mTBI, impulsivity, and SI; (2) assess the feasibility and tolerability of the intervention; and (3) gather preliminary clinical outcome data on SI, impulsivity, and functions that will guide future studies. Methods This is a pilot, double-blinded, randomized controlled trial. In developing this protocol, we referenced the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. We will enroll 56 participants (28 active iTBS and 28 sham iTBS). The iTBS intervention will be performed daily, 5 days a week, for 2 weeks. We will collect 10 validated, psychometric, quantitative outcome measures before, during, and after the intervention. Measures included will assess functioning, impulsivity, suicidality, posttraumatic stress disorder, and depressive symptoms. We will collect qualitative data through semistructured interviews to elicit feedback on the participants’ experiences and symptoms. We will perform quantitative and qualitative analyses to (1) assess the feasibility, tolerability, and acceptability of the treatment; (2) gather advanced neuroimaging data to assess neural changes elicited by treatment; and (3) assess improvements in outcome measures of impulsivity and suicidality in veterans with mTBI. Results This study protocol was approved by the Edward Hines, Jr. VA Hospital Institutional Review Board (Hines IRB number 14-003). This novel treatment is a 5-year research project (April 1, 2023, to March 31, 2028) funded by the Veterans Administration Rehabilitation Research and Development service (CDA2 award IK2 RX002938). Study results will be disseminated at or before the project’s end date in March 2028. Conclusions We will provide preliminary evidence of the safety, feasibility, and acceptability of a novel frontal pole iTBS treatment for mTBI, impulsivity, SI and SAs, and functional deficits. Trial Registration ClinicalTrials.gov NCT05647044; https://clinicaltrials.gov/study/NCT05647044 International Registered Report Identifier (IRRID) PRR1-10.2196/58206
BACKGROUND Suicide remains a leading cause of death among Veterans, and mild traumatic brain injury (mTBI) increases the risk of suicidal ideation and suicide attempts (SI/SA). mTBI worsens impulsivity and contributes to poor social and occupational functioning, which further increasing the risk of SI/SA. Repetitive transcranial magnetic stimulation (TMS) is a neuromodulation treatment approach designed to mimic endogenous brain rhythms. Intermittent theta burst stimulation (iTBS) is a "second-generation" form of TMS that is safe, shorter in duration, displays a minimal side effect profile, and is a promising treatment approach for impulsivity in mTBI. Our novel treatment uses frontal pole stimulation to target the ventromedial prefrontal cortex (VMPFC) and may reduce impulsivity by strengthening functional connectivity between the limbic system and frontal cortex, potentially saving lives. OBJECTIVE The objectives of this study are to (1) develop an iTBS intervention for individuals with mTBI and SI, (2) assess the feasibility and tolerability of the intervention, and (3) gather preliminary clinical outcome data on SI, impulsivity, and functioning that will guide future studies. METHODS This is a pilot, double-blinded, randomized controlled trial. In developing this protocol, we referenced SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials). We will enroll 50 subjects (25 active iTBS and 25 sham iTBS). The iTBS intervention will be performed daily, five days a week, for two weeks. We will collect quantitative outcome measures before and after the intervention. Measures included will assess functioning (Social and Occupational Functioning Assessment Scale (SOFAS), Veteran RAND-36), impulsivity (Urgency, Premeditation (lack of), Preservation (lack of), Sensation Seeking, Positive Urgency Impulsive Behavior Scale – Negative Urgency subscale (UPPS-P)), SI (Beck Suicide Scale (BSS), Columbia Suicide Severity Rating Scale (C-SSRS)), PTSD symptoms (PTSD Checklist for DSM-5 (CAPS-5) (PCL-5)), and depressive symptoms (Patient Health Questionnaire-9 (PHQ-9), Inventory for Depressive Symptoms – Self-Report (IDSSR)). We will collect qualitative data through semi-structured interviews to elicit feedback on the subject’s experience and symptoms. RESULTS This study protocol was approved by the Edward Hines Jr Veterans Administration Hospital Institutional Review Board (Hines IRB#14-003) and registered on ClinicalTrials.gov (NCT05647044). This novel treatment is a 5-year research project (04/01/2023 – 03/31/2028) funded by the VA Rehabilitation Research & Development (RR&D) service (CDA2 grant IK2 RX002938). Study results will be disseminated at or before the project’s end date in March 2028. CONCLUSIONS We will provide preliminary evidence of the safety, feasibility, and acceptability of a novel frontal pole iTBS treatment for mTBI, impulsivity, SI/SA, and functional deficits. CLINICALTRIAL ClinicalTrials.gov (NCT05647044); https://clinicaltrials.gov/study/NCT05647044
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.