Rehabilitation using spinal cord stimulation and robotic exoskeleton for spinal cord injury

Combinative Rehabilitation Strategy Combining Spatiotemporal Spinal Cord Stimulation and Real-time Triggering Exoskeleton (SCS-EXS) After Spinal Cord Injury: an Exploratory Study

This study is testing whether combining spinal cord stimulation with robotic exoskeletons can help people with spinal cord injuries improve their movement and quality of life.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 14 Years to 65 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06881134 on ClinicalTrials.gov

What this trial studies

This study investigates the combined effects of spinal cord stimulation (SCS) and robotic exoskeletons on motor recovery in patients with spinal cord injuries. SCS involves implanting a device that delivers electrical stimulation to enhance motor function, while robotic exoskeletons assist patients in walking and movement training. The trial aims to evaluate the safety and effectiveness of this innovative rehabilitation approach in improving mobility and quality of life for individuals with lower limb impairments due to spinal cord injuries. Participants will undergo a structured rehabilitation program that integrates both therapies to optimize recovery outcomes.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 14 to 65 with spinal cord injuries resulting in lower limb motor impairment, who have not seen significant improvement in motor function despite ongoing rehabilitation.

Not a fit: Patients with spinal cord injuries classified as AIS grade D or those who have not undergone prior rehabilitation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve mobility and independence for patients with spinal cord injuries.

How similar studies have performed: Previous studies have shown promising results with similar rehabilitation approaches, indicating potential for success in this combined method.

Eligibility criteria

Inclusion Criteria:

* Aged between 14 and 65 years, with no restriction on gender;
* Diagnosed with spinal cord injury resulting in lower limb motor impairment due to trauma, inflammation, tumors, vascular diseases, iatrogenic factors, or other causes, confirmed through medical history, physical examination, and auxiliary tests;
* Diagnosed with spinal cord injury for at least 6 months, undergoing continuous routine rehabilitation for at least 1 month (including but not limited to physical therapy, acupuncture, hydrotherapy, etc., with daily training time ≥ 3 hours), but with no significant improvement in motor function over the past 2 months;
* Classified according to the ASIA impairment scale (AIS) based on the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), with an impairment grade of A, B, or C;
* Generally in good health, with an expected life expectancy of ≥ 12 months;
* The subject voluntarily agrees to participate in the study, signs an informed consent form, demonstrates good compliance, and is willing to cooperate with follow-up assessments.

Exclusion Criteria:

* Suffering from other diseases affecting lower limb muscle function besides spinal cord injury, including brain diseases (such as brain tumors, stroke, etc.), lower limb vascular diseases (such as lower limb vascular occlusion), peripheral nerve diseases, lower limb bone diseases (such as osteoarthritis, joint contractures, etc.);
* Congenital or acquired abnormalities in lower limb skeletal or muscular structure;
* Presence of surgical contraindications (such as adverse reactions to anesthesia, bleeding risks, or when the surgeon deems the patient unsuitable for surgery);
* Presence of active implanted devices, such as a pacemaker, defibrillator, drug infusion pump, cochlear implant, sacral nerve stimulator, etc. (whether turned on or off);
* Unable to undergo implantation of active devices due to treatment or examination requirements for other diseases;
* Suffering from severe cardiovascular diseases: ischemic heart disease or myocardial infarction of class II or higher, uncontrolled arrhythmias (including QTc interval ≥450 ms for males or ≥470 ms for females); heart failure of NYHA class III-IV, or echocardiogram showing left ventricular ejection fraction (LVEF) \<50%;
* Coagulation dysfunction (INR \>1.5 ULN or PT \>ULN +4 seconds or APTT \>1.5 ULN), bleeding tendency, or currently receiving thrombolytic or anticoagulant therapy;
* Severe infection within 4 weeks prior to surgery (such as requiring intravenous antibiotics, antifungals, or antivirals) or soft tissue infection in the lumbar or back region, or unexplained fever \>38.5°C during screening or before surgery;
* Human Immunodeficiency Virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active pulmonary tuberculosis, active hepatitis B (HBV DNA ≥500 IU/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA levels above the detection threshold), or co-infection with both hepatitis B and C;
* Severe cerebrovascular events (including transient ischemic attacks, intracerebral hemorrhage, or ischemic stroke), deep vein thrombosis, or pulmonary embolism within 12 months prior to enrollment;
* Presence of metastatic malignant tumors or untreated malignant tumors;
* Major surgery or severe traumatic injury, fractures, or ulcers within 4 weeks prior to enrollment;
* Presence of addictive behaviors such as drug abuse or alcoholism;
* History of substance abuse of psychiatric drugs that cannot be discontinued, or presence of mental disorders;
* Pregnant women, breastfeeding women, women planning pregnancy, or women of childbearing age without reliable contraception;
* Presence of cognitive impairments or other factors preventing the patient from following treatment interventions and rehabilitation training;
* Situations that increase the risk associated with participation in the study or the study devices, and other conditions judged by the investigator that would make the patient unsuitable for inclusion in the study.

Where this trial is running

Beijing, Beijing

• Xuanwu Hospital, Capital Medical University — Beijing, Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Zhuofan Xu

Conditions: Spinal Cord Injury, Neuromodulation, Robot Assisted Gait Training, motor recovery, limb dysfunction, neuromodulation, robot-assisted rehabilitation, machine interface