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
BackgroundSuicide 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 fun...
Saved in:
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
JMIR Publications
2024-12-01
|
| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2024/1/e58206 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850060306559008768 |
|---|---|
| author | Alyssa Bernanke Rebecca Hasley Niki Sabetfakhri Harriet de Wit Bridget M Smith Lei Wang Lisa A Brenner Colleen Hanlon Noah S Philip Olusola Ajilore Amy Herrold Alexandra Aaronson |
| author_facet | Alyssa Bernanke Rebecca Hasley Niki Sabetfakhri Harriet de Wit Bridget M Smith Lei Wang Lisa A Brenner Colleen Hanlon Noah S Philip Olusola Ajilore Amy Herrold Alexandra Aaronson |
| author_sort | Alyssa Bernanke |
| collection | DOAJ |
| description |
BackgroundSuicide 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.
ObjectiveThe 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.
MethodsThis 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.
ResultsThis 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.
ConclusionsWe 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 RegistrationClinicalTrials.gov NCT05647044; https://clinicaltrials.gov/study/NCT05647044
International Registered Report Identifier (IRRID)PRR1-10.2196/58206 |
| format | Article |
| id | doaj-art-872486583e42425282d6437489c71f33 |
| institution | DOAJ |
| issn | 1929-0748 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj-art-872486583e42425282d6437489c71f332025-08-20T02:50:37ZengJMIR PublicationsJMIR Research Protocols1929-07482024-12-0113e5820610.2196/58206Frontal 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 TrialAlyssa Bernankehttps://orcid.org/0009-0000-9036-717XRebecca Hasleyhttps://orcid.org/0009-0000-4373-4221Niki Sabetfakhrihttps://orcid.org/0000-0002-5062-5661Harriet de Withttps://orcid.org/0000-0002-7211-8994Bridget M Smithhttps://orcid.org/0000-0002-3301-8843Lei Wanghttps://orcid.org/0000-0003-3870-3388Lisa A Brennerhttps://orcid.org/0000-0002-2629-214XColleen Hanlonhttps://orcid.org/0000-0002-3151-0279Noah S Philiphttps://orcid.org/0000-0002-4889-8775Olusola Ajilorehttps://orcid.org/0000-0003-0737-0437Amy Herroldhttps://orcid.org/0000-0001-5675-4053Alexandra Aaronsonhttps://orcid.org/0000-0001-9015-2240 BackgroundSuicide 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. ObjectiveThe 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. MethodsThis 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. ResultsThis 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. ConclusionsWe 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 RegistrationClinicalTrials.gov NCT05647044; https://clinicaltrials.gov/study/NCT05647044 International Registered Report Identifier (IRRID)PRR1-10.2196/58206https://www.researchprotocols.org/2024/1/e58206 |
| spellingShingle | Alyssa Bernanke Rebecca Hasley Niki Sabetfakhri Harriet de Wit Bridget M Smith Lei Wang Lisa A Brenner Colleen Hanlon Noah S Philip Olusola Ajilore Amy Herrold Alexandra Aaronson 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 Research Protocols |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://www.researchprotocols.org/2024/1/e58206 |
| work_keys_str_mv | AT alyssabernanke frontalpoleneuromodulationforimpulsivityandsuicidalityinveteranswithmildtraumaticbraininjuryandcommoncooccurringmentalhealthconditionsprotocolforapilotrandomizedcontrolledtrial AT rebeccahasley frontalpoleneuromodulationforimpulsivityandsuicidalityinveteranswithmildtraumaticbraininjuryandcommoncooccurringmentalhealthconditionsprotocolforapilotrandomizedcontrolledtrial AT nikisabetfakhri frontalpoleneuromodulationforimpulsivityandsuicidalityinveteranswithmildtraumaticbraininjuryandcommoncooccurringmentalhealthconditionsprotocolforapilotrandomizedcontrolledtrial AT harrietdewit frontalpoleneuromodulationforimpulsivityandsuicidalityinveteranswithmildtraumaticbraininjuryandcommoncooccurringmentalhealthconditionsprotocolforapilotrandomizedcontrolledtrial AT bridgetmsmith frontalpoleneuromodulationforimpulsivityandsuicidalityinveteranswithmildtraumaticbraininjuryandcommoncooccurringmentalhealthconditionsprotocolforapilotrandomizedcontrolledtrial AT leiwang frontalpoleneuromodulationforimpulsivityandsuicidalityinveteranswithmildtraumaticbraininjuryandcommoncooccurringmentalhealthconditionsprotocolforapilotrandomizedcontrolledtrial AT lisaabrenner frontalpoleneuromodulationforimpulsivityandsuicidalityinveteranswithmildtraumaticbraininjuryandcommoncooccurringmentalhealthconditionsprotocolforapilotrandomizedcontrolledtrial AT colleenhanlon frontalpoleneuromodulationforimpulsivityandsuicidalityinveteranswithmildtraumaticbraininjuryandcommoncooccurringmentalhealthconditionsprotocolforapilotrandomizedcontrolledtrial AT noahsphilip frontalpoleneuromodulationforimpulsivityandsuicidalityinveteranswithmildtraumaticbraininjuryandcommoncooccurringmentalhealthconditionsprotocolforapilotrandomizedcontrolledtrial AT olusolaajilore frontalpoleneuromodulationforimpulsivityandsuicidalityinveteranswithmildtraumaticbraininjuryandcommoncooccurringmentalhealthconditionsprotocolforapilotrandomizedcontrolledtrial AT amyherrold frontalpoleneuromodulationforimpulsivityandsuicidalityinveteranswithmildtraumaticbraininjuryandcommoncooccurringmentalhealthconditionsprotocolforapilotrandomizedcontrolledtrial AT alexandraaaronson frontalpoleneuromodulationforimpulsivityandsuicidalityinveteranswithmildtraumaticbraininjuryandcommoncooccurringmentalhealthconditionsprotocolforapilotrandomizedcontrolledtrial |