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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
VA Office of Research and Development
Study ID
NCT07158567
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Chronic Low Back Pain
  • Musculoskeletal Pain

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • intermittent theta burst stimulation — DEVICE
    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.
  • LoveYourBrain Yoga Program — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Jun 1, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
213 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: active-iTBS+yoga
    real or active intermittent theta burst stimulation provided prior to participation in small group LoveYourBrain Yoga program class
  • Placebo Comparator: sham-iTBS+yoga
    fake, 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 Comparator: active-iTBS alone
    real or active intermittent theta burst stimulation alone (no yoga participation)

Primary Outcome Measure

Brief Pain Inventory - Pain Severity [ Time Frame: 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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Jesse Brown VA Medical Center, Chicago, ILChicagoIllinois60612
Howard S Gordon, MD
[email protected]
312-569-7331
Edward Hines Jr. VA Hospital, Hines, ILHinesIllinois60141-3030
Gabriella G Amador
[email protected]
William Wolf, PhD
[email protected]
(708) 202-5689
Amy A Herrold, PhD BA (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
Jesse Brown VA Medical Center, Chicago, IL· Chicago, ILEdward Hines Jr. VA Hospital, Hines, IL· Hines, IL

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