Neuromodulation and Yoga for Mild Traumatic Brain Injury and Chronic Pain

NCT04517604 | Completed Results FDA Device

• 2 other identifiers: N3611-PI21RX003611
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this VA SPiRE application are to develop a combined neuromodulation and yoga (iTBS+yoga) intervention for Veterans with mild traumatic brain injury (mTBI) and chronic pain, assess the intervention's feasibility and acceptability, and to gather preliminary clinical outcome data on quality of life, function and pain that will guide future studies. This SPiRE project will directly benefit Veterans and VA Services by developing a new, non-pharmacological neurorehabilitation treatment for Veterans with mTBI and chronic pain in need of non-opioid treatment options. Neuromodulation is now offered at 30 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-pharmacological treatment for Veterans with mTBI and chronic pain is of great need given the high prevalence of chronic pain.

Conditions

Mild Traumatic Brain Injury; Chronic Pain

Keywords

traumatic brain injury; concussion; chronic pain; pain; neuromodulation; transcranial magnetic stimulation; intermittent theta burst stimulation; yoga

Outcome Measures

Primary Outcomes (1)

• Session Completion Rate

  For feasibility, we will track the number of iTBS+yoga sessions completed and compute completion percentage rates for each participant as a metric of feasibility.

  Endpoint - after last iTBS+yoga session, approximately 6 weeks

Secondary Outcomes (2)

• Mayo-Portland Adaptability Index - Total

  Endpoint (after last iTBS+yoga treatment, approximately 6 weeks)

• Brief Pain Inventory - Pain Severity

  Endpoint (after last iTBS+yoga treatment, approximately 6 weeks)

Study Arms (1)

iTBS+yoga

EXPERIMENTAL

Participants will receive 6 sessions of intermittent theta burst stimulation (iTBS) and the LoveYourBrain Yoga program. The LoveYourBrain Yoga program was specifically designed for people with TBI.

Device: Magventure MagProx100 with MagOption

Interventions

Magventure MagProx100 with MagOption DEVICE

The Magventure C-B60 butterfly coil will be used for single-pulse TMS to determine motor threshold. iTBS will be delivered utilizing the MagVentrure MagPro X100 with MagOption stimulator that includes active and placebo coils (C-B65 Butterfly coils) or active-only Cool-B65 Butterfly (figure 8) coil. Only the active setting will be used.

iTBS+yoga

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years of age
• Can read and speak English
• Perceive themselves as able to participate in gentle physical movements and cleared by study physician to do so.
• mTBI Criteria: Symptom Attribution and Classification (SACA) criteria for mTBI (without requirement of clinical neuropsychological impairment)
• Chronic pain: pain that persists for \>6 months and is of moderate to severe intensity with a score of \>5 on specific items on the Brief Pain Inventory (BPI)
• Fully vaccinated against COVID-19 prior to study participation

You may not qualify if:

• Contraindications to iTBS/TMS (e.g. epilepsy, history of anoxic brain injury or heart disease)
• Contraindications to MRI (e.g., claustrophobia, ferromagnetic metal implants)
• Pain believed to be associated with cardiac or ischemic conditions
• Active seizure disorder, or if they are taking psychostimulants (e.g. amphetamines), anticholinergics or other medications that may increase their risk of having seizures
• History of moderate to severe TBI
• History of or current psychosis not due to an external cause (e.g., due to illicit drug use)
• Are pregnant or nursing
• Within 12 weeks of a major surgery/operation
• Have questionably valid test profiles

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030, United States

Location

Related Publications (1)

• Krese KA, Donnelly KZ, Etingen B, Bender Pape TL, Chaudhuri S, Aaronson AL, Shah RP, Bhaumik DK, Billups A, Bedo S, Wanicek-Squeo MT, Bobra S, Herrold AA. Feasibility of a Combined Neuromodulation and Yoga Intervention for Mild Traumatic Brain Injury and Chronic Pain: Protocol for an Open-label Pilot Trial. JMIR Res Protoc. 2022 Jun 15;11(6):e37836. doi: 10.2196/37836.

  PMID: 35704372 DERIVED

MeSH Terms

Conditions

Brain Concussion; Chronic Pain; Brain Injuries, Traumatic; Pain

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The main limitations were the small sample size, open-label design, and lack of a control group. As this was a pilot we did not assess for multiple comparisons. Our satisfaction ratings and qualitative interviews assessing acceptability may be biased as they were only done for those completing all 6 intervention sessions.

Results Point of Contact

• Title: Dr. Amy Herrold
• Organization: Edward Hines Jr., VA Hospital

amy.herrold@va.gov

708-202-5867

Study Officials

• Amy A Herrold, PhD BA

  Edward Hines Jr. VA Hospital, Hines, IL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Intermittent Theta Burst Stimulation (iTBS) in combination with Love Your Brain Yoga Program. 6 weekly sessions of iTBS given prior to small group yoga.

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: August 18, 2020
• Study Start: June 1, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: July 16, 2025
• Results First Posted: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: After primary publication of study data.
• Access Criteria: These data will be available upon request by researchers and scientists in accordance with federal guidelines and Hines local policy.

Locations

US (1)