ReviewSpinal cord2026
Study design considerations in clinical trials testing transcutaneous stimulation for spinal cord injury.
Review in Spinal cord, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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.
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.
Who cites it
3 citing papers in PubMed.
- Article
- Reply to Butler and colleagues: sham design, parameter optimization, and the evolution of evidence in transcutaneous spinal cord stimulation.Spinal cord · 2026Article
- Spasticity and Abnormal Tone Regulation After Spinal Cord Injury: Mechanisms and the Effects of Neuromodulation.Biomedicines · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
designMethodological review and expert perspective.
objectivesTo examine the methodological challenges in designing rigorous clinical trials for transcutaneous spinal cord stimulation (tSCS) in chronic spinal cord injury (SCI), with particular focus on challenges of sham control implementation, and to propose alternative trial design approaches that balance scientific rigor with practical feasibility and ethical considerations.
settingUnited States.
methodsWe analyzed the design considerations that influenced the Up-LIFT pivotal trial, examining three critical constraints: the technical limitations of creating safe and convincing sham stimulation for extended protocols; the participant burden associated with traditional sham-controlled designs; and the heightened risks during the COVID-19 pandemic. We reviewed existing literature on placebo effects in neuromodulation, technical challenges of sham tSCS implementation, and ethical considerations specific to the SCI population. Alternative methodological approaches were evaluated, including sequential self-controlled designs, biomarker-guided approaches, and adaptive trial designs.
resultsTraditional sham controls for tSCS face serious technical challenges because participants readily detect stimulation parameters, minimal currents produce detectable neuromodulatory effects, and extended protocols amplify these issues through knowledge sharing and functional feedback. Ethical concerns include substantial participant burden, potential for lessebo effects when a sham is suspected, and erosion of therapeutic relationships through prolonged deception. The COVID-19 pandemic added critical safety considerations for the vulnerable SCI population. Alternative designs, such as sequential self-controlled approaches, as implemented in Up-LIFT, can maintain scientific validity while addressing these constraints.
conclusionThe unique challenges of tSCS clinical trials necessitate innovative methodological approaches beyond traditional placebo-controlled designs. Sequential self-controlled designs, biomarker-guided studies, and adaptive trial methodologies offer scientifically sound alternatives that respect participant welfare while generating robust evidence. Future research should pursue dual paths: developing improved sham paradigms while advancing alternative trial methodologies suitable for neuromodulation-enhanced rehabilitation interventions.
Indexed as
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What OpenQuestion holds
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.