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New treatment option for Spinal Cord Injuries (SCI)
Official title Epidural Electrical Stimulation in Spinal Cord Injury
ClinicalTrials.gov ID: NCT07105878
What this study is testing
- What it's testing
- The goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) in motor and sensory function Reconstruction in chronic spinal cord injury (SCI) patients classified as ASIA B-D. The main questions it aims to answer are: Does EES treatment significantly improve motor and sensory function in patients with SCI compared to baseline?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 60
You may be able to join if
- Spinal Cord Injury, ASIA B-D;
- Spinal cord injury level above T10;
- Diagnosed with spinal cord injury for ≥ 8 months and ≤ 36 months;
- WISCI II score \< 13;
- No significant improvement in motor dysfunction after rehabitation over the past 2 months.
You likely can't join if
- people with other severe organic neurological diseases, mental illnesses other than anxiety/depression.
- people with hemorrhagic diathesis or coagulation dysfunction (prothrombin time [PT] ≥ 18 seconds).
- people with a history of alcohol or drug abuse or dependence.
- people with mental retardation, cognitive dysfunction, or personality disorders.
- people with a history of electroconvulsive therapy or those requiring continuous electrotherapy.
- people with implanted cardiac pacemakers, cardioverters, or defibrillators. Expected survival period \< 1 year.
See the full eligibility criteria
- Spinal Cord Injury, ASIA B-D;
- Spinal cord injury level above T10;
- Diagnosed with spinal cord injury for ≥ 8 months and ≤ 36 months;
- WISCI II score \< 13;
- No significant improvement in motor dysfunction after rehabitation over the past 2 months.
- An expected survival period of ≥ 12 months.
- people voluntarily participate in this study, sign the informed consent form, have good compliance, cooperate with necessary postoperative rehabilitation training and tests, and assist in follow-up visits.
- people with other severe organic neurological diseases, mental illnesses other than anxiety/depression.
- people with hemorrhagic diathesis or coagulation dysfunction (prothrombin time [PT] ≥ 18 seconds).
- people with a history of alcohol or drug abuse or dependence.
- people with mental retardation, cognitive dysfunction, or personality disorders.
- people with a history of electroconvulsive therapy or those requiring continuous electrotherapy.
- people with implanted cardiac pacemakers, cardioverters, or defibrillators. Expected survival period \< 1 year.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.