Recovery and Safety After Epidural Spinal Cord Stimulation in People With Spinal Cord Injury

Condition(s) studied

Investigational drug(s) / intervention(s)

Epidural Spinal Cord Stimulation: Electrical stimulation delivered through previously implanted epidural electrodes connected to a pulse generator. Stimulation parameters and associated rehabilitation will be described using available clinical records. This retrospective study reviews prior treatment and does not assign implantation or stimulation.

Study summary

Spinal cord injury can cause lasting difficulties with movement, sensation, bladder and bowel function, and daily activities. Epidural spinal cord stimulation delivers electrical pulses through implanted electrodes and may be used together with rehabilitation to support recovery.

This retrospective case series will review clinical records from six patients with spinal cord injury who previously received implanted epidural spinal cord stimulation at Haikou People's Hospital. Three of the patients are children. The study aims to describe changes in movement, sensation, standing and walking ability, daily activities, and other functions, as documented in the available records. It will also summarize complications related to implantation, the stimulation system, and stimulation during follow-up.

The research involves reviewing existing treatment and follow-up information. Participation in this retrospective study does not require a new implantation procedure or changes to the patient's treatment.

Eligibility

Primary outcome measure(s)

• Change in American Spinal Injury Association Impairment Scale (AIS) Grade — Pre-surgery and last available neurological follow-up, up to 24 months after implantation.
  Change in American Spinal Injury Association Impairment Scale (AIS) grade from pre-surgery to the last available neurological follow-up, based on the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). AIS grades range from A (complete injury) to E (normal motor and sensory function in a person with previous deficits). Pre-surgery and follow-up grades and individual grade transitions will be described for each patient.
• Number of Patients With Implantation-, Device-, or Stimulation-Related Adverse Events — From implantation to the last available safety follow-up, up to 24 months.
  Number of patients with documented adverse events related to implantation, the stimulation system, or stimulation during follow-up. Events include infection, wound complications, electrode migration, hardware malfunction, and stimulation-related discomfort. Event type, severity, timing, and any treatment interruption or revision procedure will be summarized when documented.
• Change in Medical Research Council (MRC) Muscle Strength Grades — From implantation to the last available safety follow-up, up to 24 months.
  Changes in muscle strength from pre-surgery to the last available follow-up will be described using the Medical Research Council (MRC) scale. Each assessed muscle is graded from 0 (no contraction) to 5 (normal strength). Findings will be reported separately for each assessed muscle group and side.
• Change in ISNCSCI Lower Extremity Motor Score — From implantation to the last available safety follow-up, up to 24 months.
  Change in the lower extremity motor score of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) from pre-surgery to the last available follow-up. The score is the sum of grades for five key muscle functions on each side and ranges from 0 to 50, with higher scores indicating better lower extremity motor function.
• Change in ISNCSCI Light Touch Score — From implantation to the last available safety follow-up, up to 24 months.
  Change in the light touch total score of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) from pre-surgery to the last available follow-up. The bilateral total score ranges from 0 to 112, with higher scores indicating better light touch sensation.
• Change in ISNCSCI Pin Prick Score — From implantation to the last available safety follow-up, up to 24 months.
  Change in the pin prick total score of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) from pre-surgery to the last available follow-up. The bilateral total score ranges from 0 to 112, with higher scores indicating better pin prick sensation.
• Change in Neurogenic Bladder Symptom Score (NBSS) — From implantation to the last available safety follow-up, up to 24 months.
  Change in the Neurogenic Bladder Symptom Score (NBSS) total score from pre-surgery to the last available follow-up. The total score ranges from 0 to 74, with higher scores indicating more severe bladder-related symptoms. Changes will be described for patients with available assessments.

Trial sites (1)

Other trials for the same condition