Spinal Cord InjuryNCT07717606
Epidural Stimulation and Rehabilitation for Spinal Cord Injury
An observational study of Spinal Cord Injury and Conus Medullaris Injury, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 61 years
- Conditions the study is for
- Spinal Cord Injury, Conus Medullaris Injury, Conus Region Involvement
- What is being tested?
- Epidural Electrical Stimulation (EES)
- Type of treatment
- Medical device
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2026to 31 Jan 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 61 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Gelisim University
Istanbul, Istanbul, 34310
About this study
Official title: Early Functional Change After Epidural Electrical Stimulation Combined With Structured Rehabilitation in Spinal Cord Injury With Conus-Region Involvement: An Exploratory Cohort Analysis
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.
- Being tested
- Epidural Electrical Stimulation (EES)
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Epidural Electrical Stimulation (EES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 Months
Secondary outcomes (5)
Change in SCIM Self-Care Subscale Score
Assessment of changes in the SCIM Self-Care subscale score.
Measured: Baseline to 6 Months
Change in SCIM Respiration and Sphincter Management Subscale Score
Assessment of changes in the SCIM Respiration and Sphincter Management subscale score.
Measured: Baseline to 6 Months
Change in SCIM Mobility: Room and Toilet Subscale Score
Assessment of changes in the SCIM Mobility: Room and Toilet subscale score.
Measured: Baseline to 6 Months
Change in SCIM Mobility: Indoors and Outdoors Subscale Score
Assessment of changes in the SCIM Mobility: Indoors and Outdoors subscale score.
Measured: Baseline to 6 Months
Incidence of Device- or Procedure-Related Adverse Events
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.
Measured: Baseline to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start15 Jan 2026
- Primary completion29 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Istanbul Gelisim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Görkem Açar, Istanbul Gelisim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717606
- Sponsor's protocol ID
- 2025-20162-179
- Other IDs
- 2025
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Functional Change After Epidural Electrical Stimulation Combined With Structured Rehabilitation in Spinal Cord Injury With Conus-Region Involvement: An Exploratory Cohort Analysis
- ClinicalTrials.gov ID
- NCT07717606
- Acronym / sponsor ID
- 2025-20162-179
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Istanbul Gelisim UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 29 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Injury With Conus-Region Involvement | – | Device: Epidural Electrical Stimulation (EES)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. |
Who may qualify
- Ages
- 17 to 61 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural Electrical Stimulation (EES)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. | Device | Spinal Cord Injury With Conus-Region Involvement |
Primary outcome
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.
5 secondary outcomes
Change in SCIM Self-Care Subscale Score
Time frame: Baseline to 6 Months
Change in SCIM Respiration and Sphincter Management Subscale Score
Time frame: Baseline to 6 Months
Change in SCIM Mobility: Room and Toilet Subscale Score
Time frame: Baseline to 6 Months
Change in SCIM Mobility: Indoors and Outdoors Subscale Score
Time frame: Baseline to 6 Months
Incidence of Device- or Procedure-Related Adverse Events
Time frame: Baseline to 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury and Conus Medullaris Injury, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Spinal Cord Independence Measure (SCIM) Score (time frame: Baseline to 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.