Evidence map›Paper›PMID 35851008›Full record

ArticleBMJ open2022

Effect of epidural spinal cord stimulation after chronic spinal cord injury on volitional movement and cardiovascular function: study protocol for the phase II open label controlled E-STAND trial.

David P Darrow, David Young Balser, David Freeman, Eliza Pelrine, Andrei Krassioukov, Aaron Phillips, Theoden Netoff, Ann Parr, Uzma Samadani

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03026816 (Epidural Stimulation for Spinal Cord Injury), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
6.2field-weighted citation impact, top 3% 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.

NCT03026816 narecruitingnot on this map

Epidural Stimulation for Spinal Cord Injury

TypeinterventionalSponsorUniversity of MinnesotaRan2017 to 2028Enrolled100ConditionsSpinal Cord Injuries, Paraplegia, CompleteArmsEpidural Spinal Cord Stimulation
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 43 citations in OpenAlex.

  1. Trial
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  4. Article
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  6. Article
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  8. Article
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  10. Quantification of porcine lower thoracic spinal cord morphology with intact dura mater using high-resolution μCT.Journal of neuroimaging : official journal of the American Society of Neuroimaging
    Article
  11. Review
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

9 authors at 5 institutions in 2 countries.

David P DarrowNeurosurgery, University of Minnesota Medical School Twin Cities, Minneapolis, Minnesota, USA darro015@umn.edu.ORCID 0000-0001-9335-0584
David Young BalserRehabilitation Medicine, University of Minnesota Medical School Twin Cities, Minneapolis, Minnesota, USA.ORCID 0000-0002-4356-9307
David FreemanNeurosurgery, University of Minnesota Medical School Twin Cities, Minneapolis, Minnesota, USA.
Eliza PelrineOrthopaedic Surgery, University of Virginia School of Medicine, Charlottesville, Virginia, USA.
Andrei KrassioukovPhysical Medicine and Rehabilitation, The University of British Columbia, Vancouver, British Columbia, Canada.
Aaron PhillipsPhysiology and Pharmacology, University of Calgary, Calgary, Alberta, Canada.
Theoden NetoffBiomedical Engineering, University of Minnesota Twin Cities, Minneapolis, Minnesota, USA.
Ann ParrNeurosurgery, University of Minnesota Medical School Twin Cities, Minneapolis, Minnesota, USA.
Uzma SamadaniSurgery, Minneapolis Veterans Affairs Medical Center, Minneapolis, Minnesota, USA.
University of Minnesota · USUniversity of British Columbia · CAUniversity of Calgary · CAUniversity of Virginia · USVeterans Health Administration · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSpinal cord injury (SCI) leads to significant changes in morbidity, mortality and quality of life (QOL). Currently, there are no effective therapies to restore function after chronic SCI. Preliminary studies have indicated that epidural spinal cord stimulation (eSCS) is a promising therapy to improve motor control and autonomic function for patients with chronic SCI. The aim of this study is to assess the effects of tonic eSCS after chronic SCI on quantitative outcomes of volitional movement and cardiovascular function. Our secondary objective is to optimise spinal cord stimulation parameters for volitional movement. METHODS AND ANALYSIS: The Epidural Stimulation After Neurologic Damage (ESTAND) trial is a phase II single-site self-controlled trial of epidural stimulation with the goal of restoring volitional movement and autonomic function after motor complete SCI. Participants undergo epidural stimulator implantation and are followed up over 15 months while completing at-home, mobile application-based movement testing. The primary outcome measure integrates quantity of volitional movement and similarity to normal controls using the volitional response index (VRI) and the modified Brain Motor Control Assessment. The mobile application is a custom-designed platform to support participant response and a kinematic task to optimise the settings for each participant. The application optimises stimulation settings by evaluating the parameter space using movement data collected from the tablet application and accelerometers. A subgroup of participants with cardiovascular dysautonomia are included for optimisation of blood pressure stabilisation. Indirect effects of stimulation on cardiovascular function, pain, sexual function, bowel/bladder, QOL and psychiatric measures are analysed to assess generalisability of this targeted intervention. ETHICS AND DISSEMINATION: This study has been approved after full review by the Minneapolis Medical Research Foundation Institutional Review Board and by the Minneapolis VA Health Care System. This project has received Food and Drug Administration investigational device exemption approval. Trial results will be disseminated through peer-reviewed publications, conference presentations and seminars. TRIAL REGISTRATION NUMBER: NCT03026816.

Indexed as

Spinal Cord InjuriesSpinal Cord StimulationClinical Trials, Phase II as TopicEpidural SpaceHumansMovementQuality of LifeSpinal Cordneurological injuryneurosurgeryrehabilitation medicine

Identifiers

PMID35851008
PMCPMC9297213
OpenAlexW4285806065

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.