Epidural Stimulation and Rehabilitation for Spinal Cord Injury

NCT07717606 | Completed

• 1 other identifier: 2025-20162-179
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Conus Medullaris Injury; Conus Region Involvement

Outcome Measures

Primary Outcomes (1)

• Change in Total Spinal Cord Independence Measure (SCIM) Score

  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.

  Baseline to 6 Months

Secondary Outcomes (5)

• Change in SCIM Self-Care Subscale Score

  Baseline to 6 Months

• Change in SCIM Respiration and Sphincter Management Subscale Score

  Baseline to 6 Months

• Change in SCIM Mobility: Room and Toilet Subscale Score

  Baseline to 6 Months

• Change in SCIM Mobility: Indoors and Outdoors Subscale Score

  Baseline to 6 Months

• Incidence of Device- or Procedure-Related Adverse Events

  Baseline to 6 Months

Study Arms (1)

Spinal Cord Injury With Conus-Region Involvement

Participants with chronic spinal cord injury involving the conus region (T12 and/or L1) who underwent epidural electrical stimulation combined with a structured rehabilitation program. Functional outcomes were evaluated using the Spinal Cord Independence Measure (SCIM) over a 6-month follow-up period.

Device: Epidural Electrical Stimulation (EES)

Interventions

Epidural Electrical Stimulation (EES) DEVICE

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.

Spinal Cord Injury With Conus-Region Involvement

Eligibility Criteria

• Age: 17 Years - 61 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of individuals with chronic spinal cord injury involving the conus region (T12 and/or L1) who received epidural electrical stimulation integrated with a structured rehabilitation program. Twenty-nine participants (20 males and 9 females; age range 17-61 years) with complete baseline and follow-up assessments were included in the final analysis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Gelisim University: lead

Study Sites (1)

Istanbul Gelisim University

Istanbul, Istanbul, 34310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ress. Asst.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: January 15, 2026
• Primary Completion: January 29, 2026
• Study Completion: January 31, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

TU (1)