Yoga + Neuromodulation for Chronic Low Back Pain

(VIBRANT Trial)

Not yet recruiting at 1 trial location

Overseen By Ibuola Kale

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: VA Office of Research and Development

Must not be taking: Psychostimulants, Anticholinergics, Tricyclics, Antipsychotics

Disqualifiers: Epilepsy, Heart disease, Stroke, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of yoga and a brain stimulation technique called intermittent theta burst stimulation (iTBS) to help Veterans with chronic low back pain. The goal is to determine if this approach can reduce pain, improve daily function, lessen painkiller use, and boost quality of life. Participants will receive either real iTBS and yoga, fake iTBS and yoga, or just real iTBS without yoga. The trial seeks Veterans who have experienced moderate to severe low back pain for over six months and can safely participate in yoga exercises. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you are currently taking certain medications like psychostimulants, anticholinergics, tricyclic antidepressants, or antipsychotics, as they may increase the risk of seizures.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that intermittent theta burst stimulation (iTBS) effectively reduced chronic low back pain. The research reported no major safety concerns, indicating that the treatment is generally well-tolerated. Another review of brain stimulation methods, including iTBS, found these treatments usually safe, with no serious side effects reported.

Studies have shown the LoveYourBrain Yoga Program to be safe and acceptable. A virtual version of the program was also practical and well-received, with no safety issues reported.

Overall, both iTBS and the yoga program have been used safely in other studies, suggesting they are likely safe for participants in this clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for chronic low back pain because they combine innovative brain stimulation with holistic yoga practices. Intermittent Theta Burst Stimulation (iTBS) is a cutting-edge neuromodulation technique that uses magnetic pulses to potentially reset brain activity patterns linked to pain. Meanwhile, the LoveYourBrain Yoga Program offers a complementary approach by promoting mindfulness and body awareness, which may enhance pain management. This combination stands out because it not only addresses the neurological aspects of pain but also incorporates a mind-body approach, unlike typical pain medications or physical therapies.

What evidence suggests that this trial's treatments could be effective for chronic low back pain?

This trial will evaluate the effects of combining intermittent theta burst stimulation (iTBS) with the LoveYourBrain Yoga Program for managing chronic low back pain (CLBP). Studies have shown that iTBS can significantly reduce pain in people with CLBP. In one study, participants who received real iTBS experienced more pain relief than those who received a placebo treatment, demonstrating its potential effectiveness. Additionally, research suggests that the LoveYourBrain Yoga Program can improve health aspects like strength, balance, and flexibility. Specifically, participants in that yoga study reported using less pain medication after just 12 weeks. This trial will test the combination of iTBS with yoga as a promising non-drug option for managing CLBP, especially for those seeking alternatives to medication. ^{1 2 4 6 7}

Who Is on the Research Team?

Amy A Herrold, PhD BA

Principal Investigator

Edward Hines Jr. VA Hospital, Hines, IL

Are You a Good Fit for This Trial?

The VIBRANT trial is for Veterans experiencing chronic low back pain who are seeking non-opioid treatment options. Participants should be interested in a combination of neuromodulation therapy and yoga. Specific eligibility criteria were not provided, so additional details would be needed to fully determine who can participate.

Inclusion Criteria

Can read and speak English

My pain management plan has been stable for at least 1 month.

I am cleared by a doctor to do yoga for exercise.

Exclusion Criteria

Contraindications to MRI (e.g., claustrophobia, implanted ferromagnetic device such as pacemaker or cardiac defibrillator)

History of moderate to severe TBI

History of or current psychosis not due to an external cause (e.g., due to illicit drug use)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active or sham intermittent theta burst stimulation (iTBS) followed by yoga in small group settings once a week for 6 weeks

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up at 1 week, 2 weeks, 6 weeks, and 6 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Intermittent Theta Burst Stimulation
• LoveYourBrain Yoga Program

Trial Overview This study tests whether a mix of intermittent theta burst stimulation (a type of brain stimulation) and the LoveYourBrain Yoga Program can improve pain, function, medication use, self-confidence in managing health, quality of life, and overall well-being among Veterans with chronic lower back pain.

How Is the Trial Designed?

Group I: active-iTBS+yoga Experimental Treatment 2 Interventions

real or active intermittent theta burst stimulation provided prior to participation in small group LoveYourBrain Yoga program class

Group II: active-iTBS alone Active Control 1 Intervention

real or active intermittent theta burst stimulation alone (no yoga participation)

Group III: sham-iTBS+yoga Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12050991/

Impact of Intermittent Theta Burst Stimulation on Pain Relief ... This study showed a facilitatory effect of iTBS on alleviating CLBP, which might be modulated by brain functional connectivity.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06709963

The Effect of Intermittent Theta Burst Stimulation on Brain ... The goal of this clinical trial is to explore the effects of accelerated intermittent Theta Burst Stimulation (iTBS) on pain relief and cognitive function ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40321017/

Impact of Intermittent Theta Burst Stimulation on Pain Relief ... Results: The active iTBS group had a greater pain reduction than the sham group (p = 0.05, 95% CI: -0.009 to 1.109). In the active and sham groups, 80% (16/20) ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/24740527.2023.2300026

Changes in pain following bilateral intermittent theta-burst ... Of 104 patients, 52 reported moderate pain at baseline (50.0%). Median BDI-II scores decreased from 38.0 (interquartile range [IQR] = 29.0–44.0) to 24.0 (IQR = ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999324010451

Effectiveness of Intermittent Theta Burst Stimulation to ... Our findings suggest that mCIMT with and without the application of iTBS has increased the UE motor function in low-functioning PwS.

6. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2023.1135689/full

The immediate effects of iTBS on the muscle activation ... The effect of intermittent theta burst stimulation (iTBS) over the DLPFC to the capacity of postural control of CLBP patients is still unknown.

7. bmjopen.bmj.com bmjopen.bmj.com/content/15/9/e103925

Dosage and safety of transcranial magnetic stimulation and ... This review specifically focuses on brain stimulation interventions involving rTMS, TBS-TMS or theta-burst stimulation (TBS), and tDCS. Accordingly, the search ...