Recruitment Challenges in Spinal Cord Stimulation Trial for Motor Recovery in Patients with Chronic Complete Spinal Cord Injury
Abstract
:1. Introduction
2. Methods
2.1. Addressing the Limited Patient Population and Strict Eligibility Criteria
2.2. Mitigating Patient Skepticism and Fear of Invasive Procedures
2.3. Reducing Potential Medical Complications
2.4. Overcoming Geographical and Logistical Barrier
2.5. Addressing Emotional and Psychological Barrier
2.6. Study Dedicated Clinical Research Coordinator (CRC)
3. Results
4. Discussion
4.1. Recruitment Barriers and Strategies
4.2. Family Support
4.3. Ethical Considerations
- Autonomy was upheld by ensuring participants provided informed consent after a thorough understanding of the risks and benefits of this study [34,36]. Trial participants in our study underwent a comprehensive process that included counselling sessions with the PI prior to obtaining consent. This included detailed conversations about the study procedures, potential outcomes, and any associated risk. This approach ensured that patients’ decisions were based on their complete understanding of this study.
- Beneficence was reflected in the trial design, which aimed to maximize potential benefits, such as improving neurological function through innovative therapies [36]. On top of that, the team ensured that participants were emotionally healthy and had strong family support to assist them throughout the trial before recruiting them.
- Non-maleficence was prioritized by meticulously assessing risks, particularly given the invasive nature of spinal cord stimulation (SCS), and by maintaining participant safety as the trial’s foremost concern [34]. The strict eligibility criteria (Appendix A) established in our study were crucial in upholding the principle of non-maleficence, as we excluded patients suffering from severe spasticity and osteoporosis, safeguarding them against potential deterioration of their conditions.
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Appendix A
Appendix B
References
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Misbaah, F.; Lui, W.L.; Ng, Z.Y.V.; Wee, S.K.; Phua, M.W.; So, R.Q.; Premchand, B.; Susanto, K.; Saffari, S.E.; Justin Ker, R.X.; et al. Recruitment Challenges in Spinal Cord Stimulation Trial for Motor Recovery in Patients with Chronic Complete Spinal Cord Injury. J. Clin. Med. 2025, 14, 3925. https://doi.org/10.3390/jcm14113925
Misbaah F, Lui WL, Ng ZYV, Wee SK, Phua MW, So RQ, Premchand B, Susanto K, Saffari SE, Justin Ker RX, et al. Recruitment Challenges in Spinal Cord Stimulation Trial for Motor Recovery in Patients with Chronic Complete Spinal Cord Injury. Journal of Clinical Medicine. 2025; 14(11):3925. https://doi.org/10.3390/jcm14113925
Chicago/Turabian StyleMisbaah, Fatimah, Wen Li Lui, Zhi Yan Valerie Ng, Seng Kwee Wee, Min Wee Phua, Rosa Q. So, Brian Premchand, Kezia Susanto, Seyed Ehsan Saffari, Rui Xin Justin Ker, and et al. 2025. "Recruitment Challenges in Spinal Cord Stimulation Trial for Motor Recovery in Patients with Chronic Complete Spinal Cord Injury" Journal of Clinical Medicine 14, no. 11: 3925. https://doi.org/10.3390/jcm14113925
APA StyleMisbaah, F., Lui, W. L., Ng, Z. Y. V., Wee, S. K., Phua, M. W., So, R. Q., Premchand, B., Susanto, K., Saffari, S. E., Justin Ker, R. X., Ng, W. H., & Wan, K. R. (2025). Recruitment Challenges in Spinal Cord Stimulation Trial for Motor Recovery in Patients with Chronic Complete Spinal Cord Injury. Journal of Clinical Medicine, 14(11), 3925. https://doi.org/10.3390/jcm14113925