Neuromodulation and Yoga for mTBI and Chronic Pain

• ClinicalTrials.gov Identifier: NCT04517604
• Recruitment Status: Recruiting
• First Posted: August 18, 2020
• Last Update Posted: August 2, 2021
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

Brief Summary:

The objectives of this VA SPiRE application are to develop a combined neuromodulation and yoga (iTBS+yoga) intervention for Veterans with mild traumatic brain injury (mTBI) and chronic pain, assess the intervention's feasibility and acceptability, and to gather preliminary clinical outcome data on quality of life, function and pain that will guide future studies. This SPiRE project will directly benefit Veterans and VA Services by developing a new, non-pharmacological neurorehabilitation treatment for Veterans with mTBI and chronic pain in need of non-opioid treatment options. Neuromodulation is now offered at 30 VA hospitals and yoga is among the complementary and integrative health programs being rolled out as a part of VAs Whole Health implementation efforts. Thus, should iTBS+yoga ultimately prove to be efficacious, VA facilities will be well-poised to offer this treatment. A novel, activity-based, non-pharmacological treatment for Veterans with mTBI and chronic pain is of great need given the high prevalence of chronic pain.

Condition or disease	Intervention/treatment	Phase
Mild Traumatic Brain Injury; Chronic Pain	Device: Magventure MagProx100 with MagOption	Not Applicable

Detailed Description:

Over 340,000 people have incurred a mild traumatic brain injury (mTBI) as a result of the military conflicts in Iraq and Afghanistan. mTBI leads to a host of poor rehabilitation outcomes including impairments in cognition, physical health, and psychological health. These impairments among people with TBI lead to poor quality of life (QOL). Worsening this clinical picture, the prevalence of chronic pain is estimated to be 51.5% among civilians with TBI and 43.1-70% among Veterans with TBI. Opioids are used for treating chronic pain including among people with TBI. Thus, given the ongoing opioid epidemic in the United States, it is very timely to develop alter-native, non-pharmacologic treatments for chronic pain among Veterans with mTBI. Yoga is a promising activity-based intervention for TBI and chronic pain. Yoga is an activity generally comprised of breathing exercises, gentle stretching, and meditation. Neuromodulation through transcranial magnetic stimulation (TMS) is a prom-ising non-invasive, non-pharmacological treatment for TBI and chronic pain. Intermittent theta burst stimulation (iTBS) is a type of patterned, excitatory TMS. iTBS can induce a window of neuroplasticity, making it ideally suited to boost the effects of treatments provided after it. Thus, iTBS shows promise to prime the brain for combined interventions and may magnify the impacts that these interventions would have when used alone, in order to boost outcomes. The purpose of this SPiRE project is to develop a novel, combined neuromodulation and yoga neurorehabilitation intervention for Veterans with mTBI and chronic pain, and to examine the intervention's feasibility and acceptability. Using an existing, evidence-based, yoga program created specifically for people with TBI (LoveYourBrain Yoga), the investigators will first develop a neurorehabilitation intervention that combines iTBS with yoga (iTBS+yoga), and then collect pilot data about its feasibility and acceptability. Aim 1 will develop a novel, combined iTBS+yoga neurorehabilitation intervention for Veterans with mTBI and chronic pain. Aim 2 will examine the feasibility and acceptability of the iTBS+yoga intervention for Veterans with mTBI and chronic pain. Aim 3 will gather preliminary data to provide the foundation for sample size and power considerations for a future clinical trial to examine the effectiveness of iTBS+yoga on Veterans' quality of life, function and pain out-comes. The combined intervention will be provided in small group settings once a week for 6 weeks. iTBS will be administered immediately prior to the LoveYourBrain Yoga session. Emphasizing National Institute of Neuro-logical Disorders and Stroke (NINDS) Traumatic Brain Injury Common Data Elements (TBI CDEs), the investigators will collect preliminary outcome data related to quality of life, function and pain to inform a future Merit application, should the intervention prove feasible. This SPiRE project will directly benefit Veterans and VA Services by developing a new, non-pharmacological neurorehabilitation treatment for Veterans with mTBI and chronic pain in need of non-opioid treatment options. TMS is now offered at 30 VA hospitals nationwide for treatment-resistant depression, and yoga is among the complementary and integrative health programs being rolled out as a part of VAs nation-wide Whole Health implementation efforts, with classes offered through VA service lines such as recreational therapy. Therefore, should iTBS+yoga ultimately prove to be efficacious and effective, VA facilities will be well-poised to offer this treatment. A novel, activity-based, non-pharmacological treatment for Veterans with mTBI and chronic pain is of great need given the high prevalence of chronic pain, increased risk of opioid therapy, and increased risk of developing opioid use disorders.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Intermittent Theta Burst Stimulation (iTBS) in combination with Love Your Brain Yoga Program. 6 weekly sessions of iTBS given prior to small group yoga.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility of a Combined Neuromodulation and Yoga Intervention for Veterans With Mild Traumatic Brain Injury and Chronic Pain
• Actual Study Start Date: June 1, 2021
• Estimated Primary Completion Date: November 30, 2022
• Estimated Study Completion Date: November 30, 2022

Arms and Interventions

Arm

Intervention/treatment

Experimental: iTBS+yoga; Participants will receive 6 sessions of intermittent theta burst stimulation (iTBS) and the LoveYourBrain Yoga program. The LoveYourBrain Yoga program was specifically designed for people with TBI.

Device: Magventure MagProx100 with MagOption; iTBS will be delivered utilizing the MagVentrure MagPro X100 with MagOption stimulator that includes active and placebo coils (C-B60 Butterfly coils). Only the active setting will be used.A MagVenture C-B60 coil will be used to deliver single pulse TMS to the non-dominant MC to identify the ab-ductor pollicis brevis (APB) muscle coordinates. The integrated Localite neuronavigation system will be used.

Outcome Measures

Primary Outcome Measures :

1. Session Completion Rate [ Time Frame: Endpoint - after last iTBS+yoga session, approximately 6 weeks ]
   For feasibility, we will track the number of iTBS+yoga sessions completed and compute completion percentage rates for each participant as a metric of feasibility.
2. Semi-structured qualitative interviews of acceptability [ Time Frame: Endpoint - after last iTBS+yoga session, approximately 6 weeks ]
   Regarding acceptability, the semi-structured interviews will be audio-recorded, transcribed verbatim and analyzed by 2 qualitative experts using thematic coding and constant comparison techniques. Qualitative analysis software will be used to support analyses.

Secondary Outcome Measures :

1. Mayo-Portland Adaptability Index [ Time Frame: Baseline (Pre-iTBS+yoga treatment) and Endpoint (after last iTBS+yoga treatment, approximately 6 weeks) ]
   The Mayo-Portland Adaptability Index is a TBI Common Data Element assessment of function and participation. It includes 35 items each scored on a scale of 0 to 4, with 0 meaning no problems (better), and 4 meaning severe problems (worse). Minimum (best) score would be 0 and maximum (worst) score would be 140.
2. Brief Pain Inventory [ Time Frame: Baseline (Pre-iTBS+yoga treatment) and Endpoint (after last iTBS+yoga treatment, approximately 6 weeks) ]
   The Brief Pain Inventory is a self-report measure of pain symptoms throughout the body. It has 6 main items and each item is scored on a scale of 0 to 10 with 0 meaning no pain (better), and 10 meaning pain as bad as you can imagine (worse). Minimum (best) score would be 0 and maximum (worst) score would be 50.

Eligibility Criteria

• Ages Eligible for Study: 22 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 22+ years of age
• Can read and speak English
• Perceive themselves as able to participate in gentle physical movements and cleared by study physician to do so.
• mTBI Criteria: Symptom Attribution and Classification (SACA) criteria for mTBI (without requirement of clinical neuropsychological impairment)
• Chronic pain: pain that persists for >6 months and is of moderate to severe intensity with a score of >5 on specific items on the Brief Pain Inventory (BPI)

Exclusion Criteria:

• Contraindications to iTBS/TMS (e.g. epilepsy, history of anoxic brain injury or heart disease)
• Contraindications to MRI (e.g., claustrophobia, ferromagnetic metal implants)
• History of moderate to severe TBI
• History of or current psychosis not due to an external cause (e.g., due to illicit drug use)
• Are pregnant or nursing
• Within 12 weeks of a major surgery/operation
• Have questionably valid test profiles

Contacts and Locations

Locations

United States, Illinois

Edward Hines Jr. VA Hospital, Hines, IL; Recruiting

Hines, Illinois, United States, 60141-5000

Contact: William Wolf, PhD 708-202-5689 William.Wolf@va.gov

Contact: Amanda Smithy (708) 202-8387 ext 25691 Amanda.Smithy@va.gov

Principal Investigator: Amy A Herrold, PhD BA

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Amy A Herrold, PhD BA; Edward Hines Jr. VA Hospital, Hines, IL

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT04517604
• Other Study ID Numbers: N3611-P; I21RX003611 ( U.S. NIH Grant/Contract )
• First Posted: August 18, 2020
• Last Update Posted: August 2, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Plan Description

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 insure 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.

• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR); Analytic Code
• Time Frame: After primary publication of study data.
• Access Criteria: These data will be available upon request by researchers and scientists in accordance with federal guidelines and Hines local policy.
• URL: https://fitbir.nih.gov/

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:

traumatic brain injury; concussion; chronic pain; pain; neuromodulation; transcranial magnetic stimulation; intermittent theta burst stimulation; yoga

Additional relevant MeSH terms:

Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Chronic Pain; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Pain; Neurologic Manifestations; Head Injuries, Closed; Wounds, Nonpenetrating