- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04517604
Neuromodulation and Yoga for mTBI and Chronic Pain
Feasibility of a Combined Neuromodulation and Yoga Intervention for Veterans With Mild Traumatic Brain Injury and Chronic Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amy A Herrold, PhD BA
- Phone Number: (708) 202-5867
- Email: amy.herrold@va.gov
Study Contact Backup
- Name: Ibuola Kale
- Phone Number: (708) 202-5898
- Email: Ibuola.Kale@va.gov
Study Locations
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Illinois
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Hines, Illinois, United States, 60141-3030
- Edward Hines Jr. VA Hospital, Hines, IL
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 22+ 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)
Exclusion Criteria:
- Contraindications to iTBS/TMS (e.g. epilepsy, history of anoxic brain injury or heart disease)
- Contraindications to MRI (e.g., claustrophobia, ferromagnetic metal implants)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: iTBS+yoga
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Session Completion Rate
Time Frame: Endpoint - after last iTBS+yoga session, approximately 6 weeks
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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.
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Endpoint - after last iTBS+yoga session, approximately 6 weeks
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Semi-structured qualitative interviews of acceptability
Time Frame: Endpoint - after last iTBS+yoga session, approximately 6 weeks
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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.
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Endpoint - after last iTBS+yoga session, approximately 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mayo-Portland Adaptability Index
Time Frame: Baseline (Pre-iTBS+yoga treatment) and Endpoint (after last iTBS+yoga treatment, approximately 6 weeks)
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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.
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Baseline (Pre-iTBS+yoga treatment) and Endpoint (after last iTBS+yoga treatment, approximately 6 weeks)
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Brief Pain Inventory
Time Frame: Baseline (Pre-iTBS+yoga treatment) and Endpoint (after last iTBS+yoga treatment, approximately 6 weeks)
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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.
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Baseline (Pre-iTBS+yoga treatment) and Endpoint (after last iTBS+yoga treatment, approximately 6 weeks)
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Collaborators and Investigators
Investigators
- Principal Investigator: Amy A Herrold, PhD BA, Edward Hines Jr. VA Hospital, Hines, IL
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N3611-P
- I21RX003611 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
A de-identified data set will be created and shared.Final data sets will be made available as per Hines VA Hospital local policy for long term storage and access until enterprise-level resources become available. These data will be available upon request by researchers and scientists in accordance with federal guidelines and Hines local policy.
The data provided will be sufficient for anyone to perform analogous or supplemental analyses that would permit validation of the analysis and results. The sharing of data will enable others to evaluate the data and to validate and interpret the data independently. In order to insure that replication is possible and transparency, statistical code complementary to datasets will be made available through the Federal Interagency Traumatic Brain Injury Research Informatics System.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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