Recruitment Challenges in Spinal Cord Stimulation Trial for Motor Recovery in Patients with Chronic Complete Spinal Cord Injury

Abstract

Recruiting participants for clinical trials targeting specific populations, like patients with chronic motor complete spinal cord injuries (SCIs), is challenging. The RESTORES trial evaluated spinal cord stimulation (SCS) combined with robotic neurorehabilitation for motor recovery in this population. This feasibility study enrolled three participants to assess SCS implant safety, synergistic effects of SCS and robotic rehabilitation, and clinical outcomes. Key recruitment barriers included the small patient pool, stringent eligibility criteria, patient skepticism, and logistical and emotional challenges. Strategies to address these challenges encompassed multidisciplinary collaborations with clinical centers, SCI associations, and patient support groups, including pre-surgical counselling and transparent communication. A dedicated clinical research coordinator ensured ethical compliance, logistical support, and participant engagement. Travel reimbursements, family involvement, and peer advocacy fostered accessibility and trust. Of the 115 patients screened, only 3 met the strict eligibility criteria, due to high screening failure rates and participant apprehension. Peer testimonials and family support helped enhance motivation and adherence. Ethical safeguards, like a data safety monitoring board, ensured participant safety and transparency. The RESTORES trial underscores the complexity of recruiting for pioneering interventions while highlighting the importance of tailored, patient-centric strategies. Insights gained will inform future trials and contribute to advancing SCI rehabilitation, offering hope for enhanced neurological recovery and quality of life for individuals with chronic motor complete SCI.