Conus Medullaris Injury, Conus Region Involvement, Spinal Cord Injury
Conditions
Brief summary
Spinal cord injury involving the conus region often results in severe impairments in mobility, self-care, and bladder and bowel function, substantially reducing independence and quality of life. Epidural electrical stimulation (EES), combined with structured rehabilitation, has emerged as a promising neuromodulation strategy for improving functional recovery; however, evidence in patients with conus-region involvement remains limited. This exploratory cohort study aims to evaluate functional changes following EES integrated with a standardized rehabilitation program in individuals with spinal cord injury involving the conus region. Functional independence is assessed using the Spinal Cord Independence Measure (SCIM) at baseline and during follow-up. The study also evaluates changes in SCIM subdomains related to self-care, respiration and sphincter management, and mobility, while monitoring the safety of EES throughout the rehabilitation period. The findings are expected to provide preliminary evidence regarding the feasibility, safety, and potential functional benefits of combining epidural electrical stimulation with structured rehabilitation in this specific spinal cord injury population.
Interventions
Participants received individualized epidural electrical stimulation delivered through an implanted epidural stimulation system in combination with a structured rehabilitation program. Stimulation parameters were adjusted according to clinical response, and rehabilitation included task-oriented exercises, balance training, standing, gait preparation, and functional mobility exercises throughout the 6-month follow-up period.
Sponsors
Istanbul Gelisim University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
17 Years to 61 Years
Healthy volunteers
No
Inclusion criteria
* Adults and adolescents aged 17 to 61 years. * Diagnosis of chronic spinal cord injury involving the conus region (T12 and/or L1). * Underwent epidural electrical stimulation (EES) combined with a structured rehabilitation program. * Available baseline and follow-up Spinal Cord Independence Measure (SCIM) assessments. * Provided written informed consent or consent was obtained from a legally authorized representative.
Exclusion criteria
* Spinal cord injury without conus-region involvement. * Missing baseline or follow-up functional assessment data. Incomplete clinical records preventing outcome evaluation. * Contraindications to epidural electrical stimulation or inability to participate in the rehabilitation program.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Spinal Cord Independence Measure (SCIM) Score | Baseline to 6 Months | The primary outcome is the change in total Spinal Cord Independence Measure (SCIM) score between baseline and the 6-month follow-up. The SCIM assesses functional independence in individuals with spinal cord injury, with scores ranging from 0 to 100; higher scores indicate greater functional independence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in SCIM Self-Care Subscale Score | Baseline to 6 Months | Assessment of changes in the SCIM Self-Care subscale score. |
| Change in SCIM Respiration and Sphincter Management Subscale Score | Baseline to 6 Months | Assessment of changes in the SCIM Respiration and Sphincter Management subscale score. |
| Change in SCIM Mobility: Room and Toilet Subscale Score | Baseline to 6 Months | Assessment of changes in the SCIM Mobility: Room and Toilet subscale score. |
| Change in SCIM Mobility: Indoors and Outdoors Subscale Score | Baseline to 6 Months | Assessment of changes in the SCIM Mobility: Indoors and Outdoors subscale score. |
| Incidence of Device- or Procedure-Related Adverse Events | Baseline to 6 Months | Occurrence of major procedure- or device-related adverse events, including wound infection, cerebrospinal fluid leak, lead migration, stimulation intolerance requiring discontinuation, revision surgery, or device explantation during the follow-up period. |
Countries
Turkey (Türkiye)
Outcome results
None listed