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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

213

Participants

Timeline

Start Date

June 1, 2026

Primary Completion Date

June 1, 2031

Study Completion Date

December 31, 2031

Conditions
Chronic Low Back PainMusculoskeletal Pain
Interventions
DEVICE

intermittent theta burst stimulation

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.

BEHAVIORAL

LoveYourBrain Yoga Program

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.

Trial Locations (2)

60612

Jesse Brown VA Medical Center, Chicago, IL, Chicago

60141-3030

Edward Hines Jr. VA Hospital, Hines, IL, Hines

All Listed Sponsors
lead

VA Office of Research and Development

FED