N/A
N=19
Neuromodulation and Yoga for Mild Traumatic Brain Injury and Chronic Pain
Mild Traumatic Brain Injury · Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT04517604 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Session Completion Rate — 60 number of sessions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Magventure MagProx100 with MagOption (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Session Completion Rate |
60 | — |
| SECONDARY Mayo-Portland Adaptability Index - Total |
35.2 | .343 |
| SECONDARY Brief Pain Inventory - Pain Severity |
3.7 | .0026 sig |
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.
Eligibility 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)
- 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
Data sourced from ClinicalTrials.gov (NCT04517604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.