Evidence map›Paper›PMID 39421013›Full record

ArticleJournal of rehabilitation and assistive technologies engineering

Initial feasibility evaluation of the RISES system: An innovative and activity-based closed-loop framework for spinal cord injury rehabilitation and recovery.

Shirin Madarshahian, Tatiana Guerrero, Phyo Thuta Aung, Kristin Gustafson, James S Harrop, Dana R Johnson, Mehdi Khantan, Yunsoo Lee, Caio Matias, Michael McCurdy and 5 more

Abstract read
In one paragraph

Article in Journal of rehabilitation and assistive technologies engineering. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

15 authors.

Shirin MadarshahianRaphael Center for Neurorestoration, Thomas Jefferson University Hospital, Philadelphia, PA, USA.ORCID https://orcid.org/0000-0001-6501-7688
Tatiana GuerreroRaphael Center for Neurorestoration, Thomas Jefferson University Hospital, Philadelphia, PA, USA.
Phyo Thuta AungRaphael Center for Neurorestoration, Thomas Jefferson University Hospital, Philadelphia, PA, USA.ORCID https://orcid.org/0000-0002-6247-8304
Kristin GustafsonPhysical Medicine and Rehabilitation, Thomas Jefferson University Hospital, Philadelphia, PA, USA.
James S HarropDepartment of Neurosurgery, Thomas Jefferson University Hospital, Philadelphia, PA, USA.
Dana R JohnsonCenter for Outcomes and Measurement, Thomas Jefferson University Hospital, Philadelphia, PA, USA.
Mehdi KhantanRaphael Center for Neurorestoration, Thomas Jefferson University Hospital, Philadelphia, PA, USA.
Yunsoo LeeDepartment of Orthopedic Surgery, Rothman Orthopaedic Institute, Philadelphia, PA, USA.
Caio MatiasDepartment of Neurosurgery, Thomas Jefferson University Hospital, Philadelphia, PA, USA.
Michael McCurdyDepartment of Orthopedic Surgery, Rothman Orthopaedic Institute, Philadelphia, PA, USA.
Namrata GrampurohitCenter for Outcomes and Measurement, Thomas Jefferson University Hospital, Philadelphia, PA, USA.
MaryJane MulcaheyCenter for Outcomes and Measurement, Thomas Jefferson University Hospital, Philadelphia, PA, USA.
Alessandro NapoliRaphael Center for Neurorestoration, Thomas Jefferson University Hospital, Philadelphia, PA, USA.
Alexander VaccaroDepartment of Orthopedic Surgery, Rothman Orthopaedic Institute, Philadelphia, PA, USA.
Mijail SerruyaRaphael Center for Neurorestoration, Thomas Jefferson University Hospital, Philadelphia, PA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Electrical stimulation of the spinal cord may improve rewiring of the affected pathways. Immediate modulation of stimulation parameters, and its effects of it on kinematics and electromyographic variables is unclear. Methods: This study piloted the safety and feasibility of the Reynolds Innovative Spinal Electrical Stimulation (RISES) technology with a focus on its novel closed-loop setting. This personalized, task-specific non-invasive stimulation system enables real-time stimulation parameter modulation and supports multi-data acquisition and storage. Four SCI participants underwent a clinical trial coupled with activity-based training. Primary safety outcome measures included adverse events (AEs) and skin integrity; secondary measures were vital signs, pain, and fatigue assessed at the pre, mid, and post-stimulation sessions. The trial included open-loop and closed-loop blocks of transcutaneous spinal cord stimulation (tSCS). Results: Results showed no serious adverse events, with skin integrity unaffected. Vital signs and pain showed no significant differences across session timepoints. Fatigue levels differed significantly with post-session > mid-session > pre-session. Comparisons between open-loop and closed-loop blocks showed no significant differences in setup time, vital signs, pain, or fatigue. Average stimulation duration per task was significantly longer for open-loop (467.6 sec) than Closed-loop (410.8 sec). Conclusions: RISES, demonstrated safety and feasibility. Further work will focus on clinical efficacy.

Indexed as

closed-loopfeasibilityperson-tailoredreal-timesafetySCItask-specificTranscutaneous spinal cord stimulation

Identifiers

PMID39421013
PMCPMC11483808

What OpenQuestion holds

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Registered trials

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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.