Table 1.
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).