Spinal Cord InjuryNCT07900490
Recovery and Safety After Epidural Spinal Cord Stimulation in People With Spinal Cord Injury
An observational study of Spinal Cord Injury, run by Hainan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Epidural Spinal Cord Stimulation
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2024to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with spinal cord injury who previously received implanted epidural spinal cord stimulation and rehabilitation. This retrospective case series includes six patients, including three pediatric patients. Cases are identified from existing clinical records, with available medical, imaging, stimulation, rehabilitation, and follow-up data reviewed to describe functional outcomes and safety.
Who may be able to join
- Patients with spinal cord injury who previously underwent implantation of an epidural spinal cord stimulation system.
- Availability of sufficiently complete medical records, imaging, stimulation parameters, rehabilitation records, and follow-up assessments.
- For adult participants, informed consent to participate in the study. For minors, consent from a legally authorized representative and assent from the participant according to their capacity to understand.
Who cannot join
- Missing key information that prevents assessment of the main study outcomes.
- Refusal by the participant or legally authorized representative to permit the use of relevant data for research or academic publication.
- Data quality judged by the investigators to be insufficient, or substantial confounding circumstances that make the case unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Recovery and Safety After Implantable Epidural Spinal Cord Stimulation in Patients With Spinal Cord Injury: A Retrospective Case Series
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.
Read the detailed description
This observational, retrospective case series will examine functional outcomes and safety in six patients with spinal cord injury who previously underwent implantation of an epidural spinal cord stimulation system at Haikou People's Hospital. The study includes three pediatric patients.
Available source materials will include medical records, imaging, neurological and functional assessments, stimulation parameters, rehabilitation records, and follow-up documentation. Electromyographic recordings and movement videos will also be reviewed when available. Clinical changes will be described within each patient using assessments obtained before implantation and at available follow-up time points.
The analysis will consider injury level, injury severity, time since injury, baseline functional status, and stimulation parameters when describing individual recovery patterns. Safety assessment will summarize documented infections, wound complications, electrode migration, hardware malfunction, stimulation-related discomfort, and other relevant adverse events.
Given the small sample size and variation among patients, the analysis will primarily use descriptive statistics and individual clinical trajectories. No between-group hypothesis testing is planned. Pediatric cases will receive particular attention in the description of functional changes and longer-term safety.
Clinical treatment decisions are not assigned by this retrospective study. Data will be coded to protect patient privacy and handled according to the approved research protocol.
- Conditions
- Spinal Cord Injury
- Being tested
- Epidural Spinal Cord Stimulation
- Keywords
- Epidural Spinal Cord Stimulation, Spinal Cord Injury Rehabilitation, Functional Recovery, Pediatric Spinal Cord Injury, Safety, Retrospective Case Series
- 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 Spinal Cord StimulationDevice
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 group | Role | What they receive |
|---|---|---|
| Patients With Spinal Cord Injury Who Received Epidural Stimulation | Six patients with spinal cord injury who previously received implanted epidural spinal cord stimulation and rehabilitation at Haikou People's Hospital, including three pediatric patients. Available clinical records and follow-up assessments will be reviewed retrospectively to describe functional changes and safety. Receives: Device: Epidural Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in American Spinal Injury Association Impairment Scale (AIS) Grade
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.
Measured: Pre-surgery and last available neurological follow-up, up to 24 months after implantation.
Number of Patients With Implantation-, Device-, or Stimulation-Related Adverse Events
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.
Measured: From implantation to the last available safety follow-up, up to 24 months.
Change in Medical Research Council (MRC) Muscle Strength Grades
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.
Measured: From implantation to the last available safety follow-up, up to 24 months.
Change in ISNCSCI Lower Extremity Motor Score
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.
Measured: From implantation to the last available safety follow-up, up to 24 months.
Change in ISNCSCI Light Touch Score
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.
Measured: From implantation to the last available safety follow-up, up to 24 months.
Change in ISNCSCI Pin Prick Score
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.
Measured: From implantation to the last available safety follow-up, up to 24 months.
Change in Neurogenic Bladder Symptom Score (NBSS)
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.
Measured: From implantation to the last available safety follow-up, up to 24 months.
Secondary outcomes (3)
Change in Modified Ashworth Scale (MAS) Grades
Changes in resistance to passive movement from pre-surgery to the last available follow-up will be described using the Modified Ashworth Scale (MAS). Grades are 0, 1, 1+, 2, 3, and 4, with higher grades indicating greater resistance to passive movement. Findings will be reported separately for each assessed muscle group and side.
Measured: From implantation to the last available safety follow-up, up to 24 months.
Change in Visual Analog Scale (VAS) Pain Score
Change in pain intensity measured using the Visual Analog Scale (VAS) from pre-surgery to the last available follow-up. Scores range from 0 (no pain) to 10 (worst imaginable pain), with lower scores indicating less pain.
Measured: From implantation to the last available safety follow-up, up to 24 months.
Change in Barthel Index Score
Change in the Barthel Index total score from pre-surgery to the last available follow-up. The score assesses independence in activities of daily living and ranges from 0 to 100, with higher scores indicating greater independence. Changes will be described for patients with available assessments.
Measured: From implantation to the last available safety follow-up, up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start30 Oct 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hainan University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Haikou People's Hospital, Capital Medical University, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900490
- Sponsor's protocol ID
- HNU-EES-202601
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Recovery and Safety After Implantable Epidural Spinal Cord Stimulation in Patients With Spinal Cord Injury: A Retrospective Case Series
- ClinicalTrials.gov ID
- NCT07900490
- Acronym / sponsor ID
- HNU-EES-202601
- Conditions
- Spinal Cord Injury
- Keywords
- Epidural Spinal Cord Stimulation, Spinal Cord Injury Rehabilitation, Functional Recovery, Pediatric Spinal Cord Injury, Safety, Retrospective Case Series
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Hainan UniversityUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Haikou People's Hospital, Capital Medical University, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 28 Oct 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 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.
Detailed description
This observational, retrospective case series will examine functional outcomes and safety in six patients with spinal cord injury who previously underwent implantation of an epidural spinal cord stimulation system at Haikou People's Hospital. The study includes three pediatric patients.
Available source materials will include medical records, imaging, neurological and functional assessments, stimulation parameters, rehabilitation records, and follow-up documentation. Electromyographic recordings and movement videos will also be reviewed when available. Clinical changes will be described within each patient using assessments obtained before implantation and at available follow-up time points.
The analysis will consider injury level, injury severity, time since injury, baseline functional status, and stimulation parameters when describing individual recovery patterns. Safety assessment will summarize documented infections, wound complications, electrode migration, hardware malfunction, stimulation-related discomfort, and other relevant adverse events.
Given the small sample size and variation among patients, the analysis will primarily use descriptive statistics and individual clinical trajectories. No between-group hypothesis testing is planned. Pediatric cases will receive particular attention in the description of functional changes and longer-term safety.
Clinical treatment decisions are not assigned by this retrospective study. Data will be coded to protect patient privacy and handled according to the approved research protocol.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Spinal Cord Injury Who Received Epidural Stimulation | – | Device: Epidural Spinal Cord StimulationSix patients with spinal cord injury who previously received implanted epidural spinal cord stimulation and rehabilitation at Haikou People's Hospital, including three pediatric patients. Available clinical records and follow-up assessments will be reviewed retrospectively to describe functional changes and safety. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with spinal cord injury who previously received implanted epidural spinal cord stimulation and rehabilitation. This retrospective case series includes six patients, including three pediatric patients. Cases are identified from existing clinical records, with available medical, imaging, stimulation, rehabilitation, and follow-up data reviewed to describe functional outcomes and safety.
Key inclusion criteria (3 listed)
- Patients with spinal cord injury who previously underwent implantation of an epidural spinal cord stimulation system.
- Availability of sufficiently complete medical records, imaging, stimulation parameters, rehabilitation records, and follow-up assessments.
- For adult participants, informed consent to participate in the study. For minors, consent from a legally authorized representative and assent from the participant according to their capacity to understand.
Key exclusion criteria (3 listed)
- Missing key information that prevents assessment of the main study outcomes.
- Refusal by the participant or legally authorized representative to permit the use of relevant data for research or academic publication.
- Data quality judged by the investigators to be insufficient, or substantial confounding circumstances that make the case unsuitable for inclusion.
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 Spinal Cord StimulationElectrical 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. | Device | Patients With Spinal Cord Injury Who Received Epidural Stimulation |
Primary outcome
Change in American Spinal Injury Association Impairment Scale (AIS) Grade
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
3 secondary outcomes
Change in Modified Ashworth Scale (MAS) Grades
Time frame: From implantation to the last available safety follow-up, up to 24 months.
Change in Visual Analog Scale (VAS) Pain Score
Time frame: From implantation to the last available safety follow-up, up to 24 months.
Change in Barthel Index Score
Time frame: From implantation to the last available safety follow-up, up to 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Yes
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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, run by Hainan University at 1 site in China.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 28 Oct 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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 American Spinal Injury Association Impairment Scale (AIS) Grade (time frame: Pre-surgery and last available neurological follow-up, up to 24 months after implantation.). The study lists 7 primary outcomes in all. 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 28 Oct 2026.