Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
- NCT ID
- NCT07158567
- Registry status
- Not yet recruiting
- Study type
- Not specified in the registry data
- Phase
- Phase 3
- Sponsor
- VA Office of Research and Development
Overview
ClinicalTrials.gov lists this study as Not yet recruiting.
Enrollment: 213 participants (Estimated).
What is being studied
No interventions are listed in the registry data.
Who may be eligible
- Ages
- Not specified in the registry data
- Sex
- Not specified in the registry data
- Healthy volunteers accepted
- No
ClinicalTrials.gov lists the following eligibility criteria.
Inclusion Criteria:
* 1 month stability in pain management strategies
* Can read and speak English
* Able to participate in strengthening, stretching, range of motion exercise via yoga as determined by study physician
* Chronic Low Back Pain (CLBP): pain in the low back that persists for \>6 months and is of moderate to severe intensity with a score of \>5 on specific items on the BPI demonstrating disability of at least 20% on the Oswestry Disability Index (ODI)
Exclusion Criteria:
* Contraindications to combined intermittent theta burst (iTBS)/transcranial magnetic stimulation (TMS), (e.g., epilepsy, psychotic spectrum disorders \[i.e. bipolar, schizophrenia\], history of anoxic brain injury)
* Moderate to severe heart disease
* Contraindications to MRI (e.g., claustrophobia, implanted ferromagnetic device such as pacemaker or cardiac defibrillator)
* Pain believed to be associated with cardiac or ischemic conditions
* Epilepsy, active seizure disorder, personal history of a seizure or individuals with a family history of epilepsy or seizure in a first degree relative
* Current prescription of psychostimulants (e.g., amphetamines), anticholinergics, tricyclic antidepressants, and antipsychotics or other medications that may increase their risk of having seizures
* Intracranial lesion
* History of ischemic or hemorrhagic stroke
* History of moderate to severe TBI
* History of or current psychosis not due to an external cause (e.g., due to illicit drug use)
* Other neurological conditions (e.g., neurodegenerative disorders)
* Active suicidal ideation with Columbia Suicide Severity Rating Scale(CSSRS) 3
* Are pregnant or nursing
* Within 12 weeks of a major surgery/operation
Study locations
2 study locations are listed.
Site recruitment status is not specified in the registry data for these locations.
Countries: United States
- Illinois, United States: 2
Sample of listed locations
- Jesse Brown VA Medical Center, Chicago, IL — Chicago, Illinois, 60612, United States — Site recruitment status not specified in the registry data
- Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, 60141-3030, United States — Site recruitment status not specified in the registry data
Study details
- Start date
- September 14, 2026
- Primary completion date
- June 1, 2031
- First posted
- September 8, 2025
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT07158567
- Registry last updated
- September 8, 2026
- QualifiedStudies registry data refreshed
- September 21, 2026
View NCT07158567 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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