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Neuromodulation and Yoga for Mild Traumatic Brain Injury and Chronic Pain

Feasibility of a Combined Neuromodulation and Yoga Intervention for Veterans With Mild Traumatic Brain Injury and Chronic Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04517604
Enrollment
19
Registered
2020-08-18
Start date
2021-06-01
Completion date
2023-08-31
Last updated
2025-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Mild Traumatic Brain Injury

Keywords

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

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.

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.

Interventions

DEVICEMagventure MagProx100 with MagOption

The Magventure C-B60 butterfly coil will be used for single-pulse TMS to determine motor threshold. iTBS will be delivered utilizing the MagVentrure MagPro X100 with MagOption stimulator that includes active and placebo coils (C-B65 Butterfly coils) or active-only Cool-B65 Butterfly (figure 8) coil. Only the active setting will be used.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No

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) * Fully vaccinated against COVID-19 prior to study participation

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) * Pain believed to be associated with cardiac or ischemic conditions * Active seizure disorder, or if they are taking psychostimulants (e.g. amphetamines), anticholinergics or other medications that may increase their risk of having seizures * 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

Design outcomes

Primary

MeasureTime frameDescription
Session Completion RateEndpoint - after last iTBS+yoga session, approximately 6 weeksFor feasibility, we will track the number of iTBS+yoga sessions completed and compute completion percentage rates for each participant as a metric of feasibility.

Secondary

MeasureTime frameDescription
Mayo-Portland Adaptability Index - TotalEndpoint (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.
Brief Pain Inventory - Pain SeverityEndpoint (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 4 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 40.

Countries

United States

Participant flow

Recruitment details

We recruited treatment-seeking Veterans from Edward Hines Jr., VA Hospital Recruitment Period: 6/2021 to 6/2023 Types of Location: Suburban VA Hospital and associated relevant clinics such as the Polytrauma/TBI clinic.

Pre-assignment details

Participants were screened over the phone with a delimited set of measures but more in-depth screening for full eligibility criteria occurred after consent/enrollment. Thus, only enrolled participants meeting full eligibility criteria were allowed to move forward and assigned to receive the treatment intervention.

Participants by arm

ArmCount
Open Label iTBS+Yoga
All patients received individual approximately 3-minute iTBS session followed by a 90-minute group LoveYourBrain yoga session. iTBS+yoga sessions occurred once a week for 6 weeks.
19
Total19

Baseline characteristics

CharacteristicOpen Label iTBS+Yoga
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
19 Participants
Age, Continuous43.1 years
Brief Pain Inventory - Pain Interference4.24 units on a scale
STANDARD_DEVIATION 2.8
Brief Pain Inventory - Pain Severity5.59 units on a scale
STANDARD_DEVIATION 1.36
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Mayo-Portland Adaptability Inventory (MPAI-4) - Ability39.7 T-Score
STANDARD_DEVIATION 9.87
Mayo-Portland Adaptability Inventory (MPAI-4) - Adjustment46.7 T-Score
STANDARD_DEVIATION 7.49
Mayo-Portland Adaptability Inventory (MPAI-4) - Participation31.5 T-Score
STANDARD_DEVIATION 10.6
Mayo-Portland Adaptability Inventory (MPAI-4) - Total39.3 T-Score
STANDARD_DEVIATION 9.03
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
7 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
9 Participants
Region of Enrollment
United States
19 Participants
Sex/Gender, Customized
Gender
cisgender men
13 Participants
Sex/Gender, Customized
Gender
cisgender women
5 Participants
Sex/Gender, Customized
Gender
transgender men
1 Participants
Sex/Gender, Customized
Gender
transgender women
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 19
other
Total, other adverse events
3 / 19
serious
Total, serious adverse events
0 / 19

Outcome results

Primary

Session Completion Rate

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.

Time frame: Endpoint - after last iTBS+yoga session, approximately 6 weeks

Population: 14 participants initiated iTBS+yoga treatment sessions and could possibly complete 6 total number of intervention sessions. Thus total number of possible sessions is 14 x 6 = 84

ArmMeasureValue (COUNT_OF_UNITS)
iTBS+YogaSession Completion Rate60 number of sessions
Secondary

Brief Pain Inventory - Pain Severity

The Brief Pain Inventory is a self-report measure of pain symptoms throughout the body. It has 4 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 40.

Time frame: Endpoint (after last iTBS+yoga treatment, approximately 6 weeks)

Population: Analysis completed on the 10 iTBS+yoga treatment completers

ArmMeasureValue (MEAN)Dispersion
iTBS+YogaBrief Pain Inventory - Pain Severity3.7 score on a scaleStandard Deviation 1.5
Comparison: This was an open-label, single group study using a within subject design. We compared pre-treatment values to post-treatment values.p-value: 0.002695% CI: [-2.63, -0.77]Mixed Models Analysis
Secondary

Mayo-Portland Adaptability Index - Total

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.

Time frame: Endpoint (after last iTBS+yoga treatment, approximately 6 weeks)

Population: Analysis completed on the 10 iTBS+yoga treatment completers

ArmMeasureValue (MEAN)Dispersion
iTBS+YogaMayo-Portland Adaptability Index - Total35.2 score on a scaleStandard Deviation 17.4
p-value: 0.34395% CI: [-16.52, 6.47]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026