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NCT Number: NCT07717606

Epidural Stimulation and Rehabilitation for Spinal Cord Injury

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Conus Medullaris Injury Conus Region Involvement Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

17 year–61 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Gelisim University

Istanbul, 34310, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Total Spinal Cord Independence Measure (SCIM) Score

    Time frame: 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 outcomes

  1. Change in SCIM Self-Care Subscale Score

    Time frame: Baseline to 6 Months

    Assessment of changes in the SCIM Self-Care subscale score.

  2. Change in SCIM Respiration and Sphincter Management Subscale Score

    Time frame: Baseline to 6 Months

    Assessment of changes in the SCIM Respiration and Sphincter Management subscale score.

  3. Change in SCIM Mobility: Room and Toilet Subscale Score

    Time frame: Baseline to 6 Months

    Assessment of changes in the SCIM Mobility: Room and Toilet subscale score.

  4. Change in SCIM Mobility: Indoors and Outdoors Subscale Score

    Time frame: Baseline to 6 Months

    Assessment of changes in the SCIM Mobility: Indoors and Outdoors subscale score.

  5. Incidence of Device- or Procedure-Related Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul Gelisim University

Other

Registry information

Official study title

Early Functional Change After Epidural Electrical Stimulation Combined With Structured Rehabilitation in Spinal Cord Injury With Conus-Region Involvement: An Exploratory Cohort Analysis

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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