Status:
COMPLETED
Neuromodulation and Yoga for Mild Traumatic Brain Injury and Chronic Pain
Lead Sponsor:
VA Office of Research and Development
Conditions:
Mild Traumatic Brain Injury
Chronic Pain
Eligibility:
All Genders
22+ years
Phase:
NA
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 th...
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 imp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04517604
Start Date
June 1 2021
End Date
August 31 2023
Last Update
July 16 2025
Active Locations (1)
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1
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-3030