Neuromodulation and Yoga for mTBI and Chronic Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04517604|
Recruitment Status : Recruiting
First Posted : August 18, 2020
Last Update Posted : August 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Mild Traumatic Brain Injury Chronic Pain||Device: Magventure MagProx100 with MagOption||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Intermittent Theta Burst Stimulation (iTBS) in combination with Love Your Brain Yoga Program. 6 weekly sessions of iTBS given prior to small group yoga.|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of a Combined Neuromodulation and Yoga Intervention for Veterans With Mild Traumatic Brain Injury and Chronic Pain|
|Actual Study Start Date :||June 1, 2021|
|Estimated Primary Completion Date :||November 30, 2022|
|Estimated Study Completion Date :||November 30, 2022|
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
iTBS will be delivered utilizing the MagVentrure MagPro X100 with MagOption stimulator that includes active and placebo coils (C-B60 Butterfly coils). Only the active setting will be used.A MagVenture C-B60 coil will be used to deliver single pulse TMS to the non-dominant MC to identify the ab-ductor pollicis brevis (APB) muscle coordinates. The integrated Localite neuronavigation system will be used.
- Session Completion Rate [ Time Frame: Endpoint - after last iTBS+yoga session, approximately 6 weeks ]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.
- Semi-structured qualitative interviews of acceptability [ Time Frame: Endpoint - after last iTBS+yoga session, approximately 6 weeks ]Regarding acceptability, the semi-structured interviews will be audio-recorded, transcribed verbatim and analyzed by 2 qualitative experts using thematic coding and constant comparison techniques. Qualitative analysis software will be used to support analyses.
- Mayo-Portland Adaptability Index [ Time Frame: Baseline (Pre-iTBS+yoga treatment) and Endpoint (after last iTBS+yoga treatment, approximately 6 weeks) ]The Mayo-Portland Adaptability Index is a TBI Common Data Element assessment of function and participation. It includes 35 items each scored on a scale of 0 to 4, with 0 meaning no problems (better), and 4 meaning severe problems (worse). Minimum (best) score would be 0 and maximum (worst) score would be 140.
- Brief Pain Inventory [ Time Frame: Baseline (Pre-iTBS+yoga treatment) and Endpoint (after last iTBS+yoga treatment, approximately 6 weeks) ]The Brief Pain Inventory is a self-report measure of pain symptoms throughout the body. It has 6 main items 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 50.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04517604
|United States, Illinois|
|Edward Hines Jr. VA Hospital, Hines, IL||Recruiting|
|Hines, Illinois, United States, 60141-5000|
|Contact: William Wolf, PhD 708-202-5689 William.Wolf@va.gov|
|Contact: Amanda Smithy (708) 202-8387 ext 25691 Amanda.Smithy@va.gov|
|Principal Investigator: Amy A Herrold, PhD BA|
|Principal Investigator:||Amy A Herrold, PhD BA||Edward Hines Jr. VA Hospital, Hines, IL|