Spinal Epidural Electrical Stimulation for recovery of motor function in lower limbs after Spinal Cord Injury: A Phase I/II clinical trial

Abstract

Study design: Single-arm prospective phase I/II clinical trial Objective: Standing and walking are highly desirable goals forpersons with spinal cord injury (SCI). Spinal epidural electrical stimulation (sEES) has been utilized to produce rhythmic activity in animals and more recently, in a few human case reports. Our objective was to assess the safety and efficacy of sEES in the recovery of motor function after severe SCI. Setting: Indian Spinal Injuries Center, New Delhi Methods: Fiveparticipantssatisfying the eligibility criteria includingsevere and chronic SCIand an absence of useful power in the lower limbswere included in the study. The Institute Ethics Committee and the Research Review Committee approved the study and it was registered with Clinical Trials Registry of India. Results: No intraoperative or early postoperative complications were noted in any of the participants. Two participants had wound complicationsat 1 and 3 months respectively and were managed successfully.Improvement in the voluntary power of lower limbs, motor abilities, and functional recoverywas noted in the majority of the participants when the sEESwas turned on. Even with sEES turned off; there was improvement in motor abilities of a participant though there was no demonstrable neurological recovery. Conclusions: sEES is a safe intervention and improves the motor and functional abilities of persons with severe and chronic SCI. Neurological recovery could not be demonstrated. However, a larger,prospective,matched controlledstudy with more participants needs to be done to draw a definite conclusion.