Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
VIBRANT
2 other identifiers
interventional
213
1 country
2
Brief Summary
The objectives of this VA Merit application are to demonstrate efficacy of combined intermittent theta burst (iTBS) and yoga (iTBS+yoga) intervention on improving pain, function, analgesic use, self-efficacy, quality of life and well-being among Veterans with chronic low back pain (CLBP). This Merit project will directly benefit Veterans and VA Services by demonstrating efficacy of a new, non-medication treatment for Veterans with CLBP in need of non-opioid treatment options. Neuromodulation including iTBS is now offered at over 50 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-medication treatment for Veterans with CLBP is of great need given the high prevalence of CLBP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2026
Longer than P75 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2025
CompletedFirst Posted
Study publicly available on registry
September 8, 2025
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2031
Study Completion
Last participant's last visit for all outcomes
December 31, 2031
September 8, 2025
August 1, 2025
5 years
August 28, 2025
August 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Brief Pain Inventory - Pain Severity
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.
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
Brief Pain Inventory - Pain Interference
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.
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
Secondary Outcomes (7)
PROMIS Pain Interference - Short Form 6b
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
PROMIS Physical Function with Mobility Aid
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
Wellbeing Signs Tool
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
Pain Self-Efficacy Questionnaire
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
Veterans Rand 36 Item Health Survey (VR-36)
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
- +2 more secondary outcomes
Study Arms (3)
active-iTBS+yoga
EXPERIMENTALreal or active intermittent theta burst stimulation provided prior to participation in small group LoveYourBrain Yoga program class
sham-iTBS+yoga
PLACEBO COMPARATORfake, inactive or sham intermittent theta burst stimulation (designed to look, sound and feel like real or active stimulation) provided prior to participation in small group LoveYourBrain Yoga program class
active-iTBS alone
ACTIVE COMPARATORreal or active intermittent theta burst stimulation alone (no yoga participation)
Interventions
Transcranial magnetic stimulation (TMS) is a non-invasive neuromodulatory treatment. TMS has been FDA cleared since 2008 for treatment resistant depression. It is now FDA cleared for a few other indications including migraine. Magnetic pulses are delivered through a coil placed on the scalp and when the magnetic field reaches brain cells, it changes to an electric current that can increase or decrease excitability depending on the treatment parameters. Intermittent theta burst stimulation (iTBS) is a type of patterned, excitatory TMS. iTBS only takes 3 minutes to deliver and is theorized to induce a window of neuroplasticity that lasts at least 1 hour. The Magventure with Magoption x100 Stimulator and associated coil the investigators are using can be set to deliver active (real) or sham (fake or inactive) TMS. The sham device is designed to look, sound and feel like real TMS.
This yoga program is evidence-based, standardized and manualized. It is developed by the LoveYourBrain Foundation (www.loveyourbrain.com). Each yoga session includes 10 min of breathing exercises, 45 min of gentle yoga or stretching exercises, 15 min of guided meditation, and 20 min of facilitated discussion with psychoeducation, detailed in a manual to ensure standardization of program content across time and instructors.
Eligibility Criteria
You may qualify if:
- mo. stability in pain management strategies.
- + years of age.
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612, United States
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy A Herrold, PhD BA
Edward Hines Jr. VA Hospital, Hines, IL
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The PI, study statistician, intervention providers, and those collecting study data will be blind to treatment assignment. While participants may be able to discern whether or not they received iTBS alone because there is no yoga component (thus, the single blind), they may not be able to guess if they received active-iTBS+yoga vs. sham-iTBS. Participants will complete a blinding questionnaire after completion of the study intervention. After follow up, the study team will become unblinded to provide participants with the opportunity to complete their preferred intervention types. The study statistician will remained blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2025
First Posted
September 8, 2025
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
June 1, 2031
Study Completion (Estimated)
December 31, 2031
Last Updated
September 8, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share