Evidence map›Paper›PMID 35704372›Full record

ArticleJMIR research protocols2022

Feasibility of a Combined Neuromodulation and Yoga Intervention for Mild Traumatic Brain Injury and Chronic Pain: Protocol for an Open-label Pilot Trial.

Kelly A Krese, Kyla Z Donnelly, Bella Etingen, Theresa L Bender Pape, Sarmistha Chaudhuri, Alexandra L Aaronson, Rachana P Shah, Dulal K Bhaumik, Andrea Billups, Sabrina Bedo and 3 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in JMIR research protocols, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04517604 (Feasibility of a Combined Neuromodulation and Yoga Intervention for Veterans With Mild Traumatic Brain Injury and Chronic Pain), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.5field-weighted citation impact, top 35% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04517604 nacompletednot on this map

Feasibility of a Combined Neuromodulation and Yoga Intervention for Veterans With Mild Traumatic Brain Injury and Chronic Pain

TypeinterventionalSponsorVA Office of Research and DevelopmentRan2021 to 2023Enrolled19ConditionsMild Traumatic Brain Injury, Chronic PainArmsMagventure MagProx100 with MagOption
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 1 country.

Kelly A KreseBrain Innovation Center, Shirley Ryan AbilityLab, Chicago, IL, United States.ORCID https://orcid.org/0000-0002-1325-710X
Kyla Z DonnellyLoveYourBrain Foundation, Norwich, VT, United States.ORCID https://orcid.org/0000-0002-2527-808X
Bella EtingenCenter for Innovation in Complex Chronic Healthcare & Research Service, Edward Hines Jr Veterans Administration Hospital, Hines, IL, United States.ORCID https://orcid.org/0000-0003-1325-9073
Theresa L Bender PapeResearch and Development Service, Edward Hines Jr Veterans Administration Hospital, Hines, IL, United States.ORCID https://orcid.org/0000-0001-7738-5963
Sarmistha ChaudhuriDepartment of Physical Medicine and Rehabilitation, Edward Hines Jr Veterans Administration Hospital, Hines, IL, United States.ORCID https://orcid.org/0000-0001-9702-1585
Alexandra L AaronsonMental Health Service Line, Edward Hines Jr Veterans Administration Hospital, Hines, IL, United States.ORCID https://orcid.org/0000-0001-9015-2240
Rachana P ShahDepartment of Physical Medicine and Rehabilitation, Edward Hines Jr Veterans Administration Hospital, Hines, IL, United States.ORCID https://orcid.org/0000-0003-1817-6410
Dulal K BhaumikResearch and Development Service, Edward Hines Jr Veterans Administration Hospital, Hines, IL, United States.ORCID https://orcid.org/0000-0002-5182-4777
Andrea BillupsResearch and Development Service, Edward Hines Jr Veterans Administration Hospital, Hines, IL, United States.ORCID https://orcid.org/0000-0001-6629-2569
Sabrina BedoDepartment of Physical Medicine and Rehabilitation, Edward Hines Jr Veterans Administration Hospital, Hines, IL, United States.ORCID https://orcid.org/0000-0002-4965-8909
Mary Terese Wanicek-SqueoRecreation Therapy, Edward Hines Jr Veterans Administration Hospital, Hines, IL, United States.ORCID https://orcid.org/0000-0002-2207-8146
Sonia BobraDepartment of Radiology, Edward Hines Jr Veterans Administration Hospital, Hines, IL, United States.ORCID https://orcid.org/0000-0002-2912-0802
Amy A HerroldResearch and Development Service, Edward Hines Jr Veterans Administration Hospital, Hines, IL, United States.ORCID https://orcid.org/0000-0001-5675-4053
Edward Hines, Jr. VA Hospital · USNorthwestern University · USLoyola University Chicago · USNorwich University · USShirley Ryan AbilityLab · US

Funding

Feasibility of a Combined Neuromodulation and Yoga Intervention for Veterans with Mild Traumatic Brain Injury and Chronic PainI21RX003611 · VA · EDWARD HINES JR VA HOSPITAL · PI HERROLD, AMY · 2021 to 2023
–
RRD VA I21 RX003611RRD VA IK1 RX003082RRD VA IK2 RX004298
6 · The paper itself

Abstract

backgroundMild traumatic brain injury (mTBI) and chronic pain often co-occur and worsen rehabilitation outcomes. There is a need for improved multimodal nonpharmacologic treatments that could improve outcomes for both conditions. Yoga is a promising activity-based intervention for mTBI and chronic pain, and neuromodulation through transcranial magnetic stimulation is a promising noninvasive, nonpharmacological treatment for mTBI and chronic pain. Intermittent theta burst stimulation (iTBS) is a type of patterned, excitatory transcranial magnetic stimulation. iTBS can induce a window of neuroplasticity, making it ideally suited to boost the effects of treatments provided after it. Thus, iTBS may magnify the impacts of subsequently delivered interventions as compared to delivering those interventions alone and accordingly boost their impact on outcomes.

objectiveThe aim of this study is to (1) develop a combined iTBS+yoga intervention for mTBI and chronic pain, (2) assess the intervention's feasibility and acceptability, and (3) gather preliminary clinical outcome data on quality of life, function, and pain that will guide future studies.

methodsThis is a mixed methods, pilot, open-labeled, within-subject intervention study. We will enroll 20 US military veteran participants. The combined iTBS+yoga intervention will be provided in small group settings once a week for 6 weeks. The yoga intervention will follow the LoveYourBrain yoga protocol-specifically developed for individuals with TBI. iTBS will be administered immediately prior to the LoveYourBrain yoga session. We will collect preliminary quantitative outcome data before and after the intervention related to quality of life (TBI-quality of life), function (Mayo-Portland Adaptability Index), and pain (Brief Pain Inventory) to inform larger studies. We will collect qualitative data via semistructured interviews focused on intervention acceptability after completion of the intervention.

resultsThis study protocol was approved by Edward Hines Jr Veterans Administration Hospital Institutional Review Board (Hines IRB 1573116-4) and was prospectively registered on ClinicalTrials.gov (NCT04517604). This study includes a Food and Drug Administration Investigational Device Exemption (IDE: G200195). A 2-year research plan timeline was developed. As of March 2022, a total of 6 veterans have enrolled in the study. Data collection is ongoing and will be completed by November 2022. We expect the results of this study to be available by October 2024.

conclusionsWe will be able to provide preliminary evidence of safety, feasibility, and acceptability of a novel combined iTBS and yoga intervention for mTBI and chronic pain-conditions with unmet treatment needs.

trial registrationClinicalTrials.gov NCT04517604; https://www.clinicaltrials.gov/ct2/show/NCT04517604. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37836.

Indexed as

chronic painconcussionmild traumatic brain injuryneuromodulationtranscranial magnetic stimulation

Identifiers

PMID35704372
PMCPMC9244651
OpenAlexW4220924237

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.