VIBRANT Study: Neuromodulation and Yoga for Chronic Low Back Pain

This study, called VIBRANT, is for Veterans with chronic low back pain (pain lasting over 6 months). It's testing a combination of two treatments: intermittent theta burst stimulation (iTBS), a non-invasive brain stimulation device, and the LoveYourBrain Yoga Program. The goal is to see if this combination can improve pain, daily function, and overall well-being. Researchers will measure pain severity and how much pain interferes with daily life at several points over about 6 months. This study aims to offer a new, non-medication option for Veterans who haven't found relief from other treatments. About 213 people are expected to join.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 213 participants.
What's involved
Participants will receive iTBS and yoga treatments for approximately 6 weeks. They will also have pain assessments at baseline, after treatment, and at 1 week, 2 weeks, 6 weeks, and 6 months post-treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after their treatment ends.

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NCT07158567

Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT

Not Yet Recruiting
PHASE3Ages 22+InterventionalTreatment
VA Office of Research and Development
~213 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:intermittent theta burst stimulationLoveYourBrain Yoga Program

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Brief Pain Inventory - Pain Severity
Measured over Baseline (Pre-intervention, Endpoint (after last iTBS+yoga treatment, approximately 6 weeks), Follow-Up at 1 week, 2 weeks, 6 weeks and 6 months post-treatment
+1 more outcome measured
Chronic Low Back Pain
Musculoskeletal Pain
2 sites across 1 states
Illinois2
  • Amy A Herrold, PhD BA · PRINCIPAL_INVESTIGATOR · Edward Hines Jr. VA Hospital, Hines, IL

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Eligibility criteria

Inclusion

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

Contraindications to iTBS/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.
  • Brief Pain Inventory - Pain SeverityBaseline (Pre-intervention, Endpoint (after last iTBS+yoga treatment, approximately 6 weeks), Follow-Up at 1 week, 2 weeks, 6 weeks and 6 months post-treatment

    The Brief Pain Inventory is a self-report measure of pain symptoms throughout the body. It has 4 main items related to pain severity 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.

  • Brief Pain Inventory - Pain InterferenceBaseline (Pre-intervention, Endpoint (after last iTBS+yoga treatment, approximately 6 weeks), Follow-Up at 1 week, 2 weeks, 6 weeks and 6 months post-treatment

    The Brief Pain Inventory is a self-report measure of pain symptoms throughout the body. t has 7 main items related to pain interference and each item is scored on a scale of 0 to 10 with 0 meaning "Does not interfere", and 10 meaning "Completely Interferences". Minimum (best) score would be 0 and maximum (worst) score would be 70.