Neuromodulation and Yoga for Mild Traumatic Brain Injury and Chronic Pain
CompletedNot applicableNCT04517604
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Feasibility of a Combined Neuromodulation and Yoga Intervention for Veterans With Mild Traumatic Brain Injury and Chronic Pain
- Conditions
- Mild Traumatic Brain Injury
- Chronic Pain
- Interventions
- Device: Magventure MagProx100 with MagOption
- Sponsor
- VA Office of Research and Development
- Start date
- 2021-06-01
- Primary completion
- 2023-08-31
- Sex
- All
- Age range
- from 22 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04517604