Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04517604 |
| Other study ID # |
N3611-P |
| Secondary ID |
I21RX003611 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
August 31, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
