An observational study in Spinal Cord Injury, sponsored by Hainan University. Active, not recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Hainan University · Observational
Among 79 studies in Spinal Cord Injuries with a site in China — 25 open to participants now, 31 under way, none of them phase 3. Spinal Cord Injuries · China.
Among the 79 studies in Spinal Cord Injuries with a site in China, this one is one of 9 that started in 2024, is one of 9 observational ones, reaches primary completion later than 9 of the 30 other live ones, and was the 78th registered.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
Browse Spinal Cord Injuries studies →25 of the 79 studies in Spinal Cord Injuries with a site in China are open now. Recruiting first, the newest first:
BCIFlex Medical Technology Co., Ltd. · Sites in China
Ages 18–65
NeuroXess Technology (shanghai) Co.,Ltd. · Sites in China
Ages 18–65
Shengjing Hospital · Sites in China
Ages 18–80
Zhongda Hospital · Sites in China
Ages 18–75
Shanghai StairMed Technology Co., Ltd. · Sites in China
Ages 18–65
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 375 Spinal Cord Injuries studies recruiting now, 166 (44%) set no upper age limit and 158 (42%) stop at 75 or younger; 41 take children under 18; 52 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
79 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 16 · Phase 2 17 · Phase 3 2 · Phase 4 1
First in 2000; this study’s year is marked. 9 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 6 is below the median of 60 across 332 observational studies indexed under Spinal Cord Injuries.
Median enrollment 38 across the 70 interventional studies, 107 across the 9 observational. Of the 23 that completed or were terminated, 3 (13%) have results posted.
This tab as a report to print or save as PDF → With an account.
13 of 79 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Hainan University as lead sponsor.
Hainan University has 1 study filed under Spinal Cord Injuries — fewer than ten, so there is no comparison to draw.
14 of the studies in Spinal Cord Injuries with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07900490Hainan UniversityRecovery and Safety After Epidural Spinal Cord Stimulation in People With Spinal Cord Injury | 2026-11-30 |
| NCT06436716Affiliated 2 Hospital of Nantong UniversityArtificial Intelligence Model for Traumatic Cervical Spinal Cord Injury Based on Radiomics and Genomics | 2026-12 |
| NCT07207798Second Affiliated Hospital, School of Medicine, Zhejiang UniversityEpidural Electrical Stimulation in Spinal Cord Injury (T11-L3) | 2026-12-30 |
| NCT07907952Beijing Tsinghua Chang Gung HospitaltSCS Combined With Rehabilitation Training in Treating Paraplegic Patients After SCI | 2026-12-31 |
| NCT07105878Second Affiliated Hospital, School of Medicine, Zhejiang UniversityEpidural Electrical Stimulation in Spinal Cord Injury | 2026-12-31 |
Add all 14 to your calendar (.ics) → With an account.
Among the 79 studies in Spinal Cord Injuries with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Epidural Spinal Cord Stimulation
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From implantation to the last available safety follow-up, up to 24 months.
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.
Time frame: 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.
Time frame: 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.
Time frame: From implantation to the last available safety follow-up, up to 24 months.
Plan to share: Yes
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Nov 2026, 25 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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