Evidence mapPaperPMID 42569182Full record

ArticleFrontiers in neuroscience2026

Safety of transcutaneous electrical stimulation potentiating recovery in acute spinal cord injury syndromes: a trial protocol.

Anastasia Keller, Prakruthi Amar Kumar, Xuan Bradfield, Debra Hemmerle, J Russell Huie, H E Hinson, Rajiv Saigal

Registry-linked trialAbstract read
In one paragraph

Article in Frontiers in neuroscience, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07090473 (Safety of Transcutaneous Electrical Stimulation Potentiating Recovery in Acute Spinal Cord Injury Syndromes), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT07090473 narecruitingnot on this map

Safety of Transcutaneous Electrical Stimulation Potentiating Recovery in Acute Spinal Cord Injury Syndromes

TypeinterventionalSponsorUniversity of California, San FranciscoRan2026 to 2028Enrolled15ConditionsAcute Spinal Cord Injury (SCI), Acute Spinal Cord Injury of Traumatic Origin (tSCI)Armstranscutaneous spinal cord stimulation, sham transcutaneous spinal cord stimulation
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

7 authors.

Anastasia KellerBrain and Spinal Injury Research Center, Department of Neurological Surgery, University of California, San Francisco, San Francisco, CA, United States.
Prakruthi Amar KumarBrain and Spinal Injury Research Center, Department of Neurological Surgery, University of California, San Francisco, San Francisco, CA, United States.
Xuan BradfieldBrain and Spinal Injury Research Center, Department of Neurological Surgery, University of California, San Francisco, San Francisco, CA, United States.
Debra HemmerleBrain and Spinal Injury Research Center, Department of Neurological Surgery, University of California, San Francisco, San Francisco, CA, United States.
J Russell HuieBrain and Spinal Injury Research Center, Department of Neurological Surgery, University of California, San Francisco, San Francisco, CA, United States.
H E HinsonBrain and Spinal Injury Research Center, Department of Neurological Surgery, University of California, San Francisco, San Francisco, CA, United States.
Rajiv SaigalBrain and Spinal Injury Research Center, Department of Neurological Surgery, University of California, San Francisco, San Francisco, CA, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background and objectives: Spinal cord injury (SCI) often results in permanent paralysis, leading to substantial long-term disability and loss of quality-adjusted life years. Strategies to preserve neural function in the hyperacute phase are needed. Transcutaneous spinal cord stimulation (tSCS) improves neurological function in chronic SCI. Earlier implementation in acute SCI may preserve or restore function and improve recovery. Methods: STEP-RAISE is a Phase 1/2 prospective clinical trial evaluating the safety and preliminary efficacy of tSCS in acute moderate-to-severe traumatic SCI. Electrical current will be delivered to the lumbosacral spinal cord using the investigational ARC-Ex device (ONWARD Medical) via surface electrodes over the thoracolumbar region. Phase 2 is a randomized, triple-blinded, placebo-controlled trial designed to assess treatment effects. Safety outcomes include hemodynamics, spinal cord perfusion pressure, and skin reactions. Efficacy will be assessed using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examination with electromyography at baseline, during stimulation, and at 6-month follow-up. Biomarkers include neuronal (UCH-L1) and glial (GFAP) markers and exploratory proteomics in blood and cerebrospinal fluid collected prior to stimulation and at discharge. Discussion: The STEP-RAISE trial evaluates safety and preliminary efficacy of non-invasive tSCS initiated within 72 h of SCI to improve sensorimotor recovery. Neurophysiological and patient-reported outcomes will characterize recovery and assess whether early tSCS augments functional recovery. This study is designed to estimate treatment effects and inform subsequent trials in acute SCI. Planned enrollment includes 5 participants in Phase 1 and 10 in Phase 2. Clinical trial registration: ClinicalTrial.gov: NCT07090473; first posted on 07/29/2025, first open to enrollment 04/2026. https://clinicaltrials.gov/study/NCT07090473.

Indexed as

acute spinal cord injuryclinical trialintensive care unitsafetyspinal cord stimulation

Identifiers

PMID42569182
PMCPMC13449234

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.