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. 2023 Jun 13;13(6):993. doi: 10.3390/jpm13060993

Table 1.

Limitations in the design and report of the existing trials assessing the effect of SCS on function in SCI patients.

Shortcomings Avenues
Disease Heterogeneity Subgroup analysis based on lesion level and post-traumatic delay
Small sample size Multicenter trial to increase sample size
Incomplete description of the therapeutic procedures Need to document the device used and the stimulation parameters
Use common technical terminologies
Detail the timing of the stimulation, follow-up, rehabilitation activities, and sample sizes.
Incomplete clinical outcomes focusing on lower motor recovery and ambulation Consider sexual, autonomic, bladder, and bowel function
Quality of life scales.
Poorly reported risk and safety issues Document adverse events
Inclusion of a designated and independent data monitoring and/or safety committee
Absence of objective surrogates Include biomarkers (MRI, electrophysiology)
Lack of comparative studies Need for comparative studies of the 3 forms of
SCS: epidural SCS, electric and magnetic transcutaneous SCS.
Absence of patient participation Engagement and participation of consumers or advocacy groups to identify treatment and outcome priorities
Need for patient’s reported outcomes
Dissemination Results of any clinical trial should comply with standardised checklist of the CONSORT guidelines
Avoid publication bias in favor of the positive studies and publish negative studies

Abbreviation: SCI (Spinal Cord Injury), SCS (spinal cord stimulation).