Chronic Pain, Mild Traumatic Brain Injury
Conditions
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
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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Session Completion Rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mayo-Portland Adaptability Index - Total | 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. |
| Brief Pain Inventory - Pain Severity | 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 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
| Arm | Count |
|---|---|
| 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 |
| Total | 19 |
Baseline characteristics
| Characteristic | Open 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, Continuous | 43.1 years |
| Brief Pain Inventory - Pain Interference | 4.24 units on a scale STANDARD_DEVIATION 2.8 |
| Brief Pain Inventory - Pain Severity | 5.59 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) - Ability | 39.7 T-Score STANDARD_DEVIATION 9.87 |
| Mayo-Portland Adaptability Inventory (MPAI-4) - Adjustment | 46.7 T-Score STANDARD_DEVIATION 7.49 |
| Mayo-Portland Adaptability Inventory (MPAI-4) - Participation | 31.5 T-Score STANDARD_DEVIATION 10.6 |
| Mayo-Portland Adaptability Inventory (MPAI-4) - Total | 39.3 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 type | EG000 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
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
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| iTBS+Yoga | Session Completion Rate | 60 number of sessions |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iTBS+Yoga | Brief Pain Inventory - Pain Severity | 3.7 score on a scale | Standard Deviation 1.5 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iTBS+Yoga | Mayo-Portland Adaptability Index - Total | 35.2 score on a scale | Standard Deviation 17.4 |