Rehabilitation Combining Spatiotemporal Spinal Cord Stimulation and Real-time Triggering Exoskeleton After Spinal Cord Injury

NCT06881134 | Completed

• 1 other identifier: 2024286001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal cord injury (SCI) can be caused by trauma, inflammation, tumors, and other factors, often leading to issues such as impaired leg movement, abnormal sensation, and difficulties with bladder and bowel control. These challenges significantly affect the patient's quality of life. While there is currently no cure for spinal cord injury, the latest guidelines recommend spinal cord stimulation and robotic exoskeletons as effective rehabilitation methods. Spinal cord stimulation (SCS) involves implanting a device that delivers electrical stimulations to aid in motor function recovery. Its safety and effectiveness have been proven in multiple clinical studies. For example, in 2022, a Swiss research team successfully helped three patients with severe spinal cord injuries regain the ability to stand, walk, and perform other movements, offering new hope for recovery. A robotic exoskeleton is a wearable device that assists patients in movements like walking while promoting nerve and muscle recovery. This technology has become an increasingly important tool in spinal cord injury rehabilitation. Recent studies have shown that combining spinal cord stimulation and robotic exoskeletons yields better outcomes. For instance, in 2023, an American research team demonstrated that after 24 weeks of combined therapy, patients could achieve independent walking or walk with the aid of assistive devices. This study aims to combine spinal cord stimulation with robotic exoskeleton therapy to develop personalized rehabilitation plans for patients. The goal is to restore lower limb motor function and improve long-term quality of life.

Conditions

Spinal Cord Injury; Neuromodulation; Robot Assisted Gait Training

Keywords

motor recovery; limb dysfunction; neuromodulation; robot-assisted rehabilitation; machine interface

Outcome Measures

Primary Outcomes (1)

• Overall muscle strength improvement rate at 6 month

  The overall muscle strength improvement rate is calculated as (Muscle strength at 6 month - Muscle strength at baseline) / Muscle strength at baseline. Muscle strength in the key muscles of both lower limbs will be assessed using the standard methods outlined in the ASIA Manual for Muscle Strength Testing. Scores will be assigned based on examination results on a scale from 0 to 5, while the anal sphincter will be scored as 0 or 1 depending on the presence or absence of contraction. The overall muscle strength is calculated as the total score of each muscle assessed.

  6 month after combinative rehabilitation

Secondary Outcomes (14)

• The overall muscle strength improvement rate at 1 month

  1 month after combinative rehabiliation

• The overall muscle strength improvement rate at 2 month

  2 month after combinative rehabilitation

• The overall muscle strength improvement rate at 3 month

  3 month after combinative rehabilitation

• The overall muscle strength improvement rate at 12 month

  12 month after combinative rehabilitation

• Assisted standing time

  6 month after combinative rehabiliation

Study Arms (1)

SCS+EXS

EXPERIMENTAL

Eligible participants will undergo implantation of the spinal cord stimulation (SCS) system. Intraoperative electrophysiological monitoring will be used to adjust stimulation parameters. SCS will be tested postoperatively to assess the patient's tolerance to stimulation and its therapeutic effects. Parameters designed to improve sensory function and bladder/bowel control will be established. All parameters will be integrated into a sequential stimulation protocol. Additionally, the simultaneous activation of the SCS and the robotic exoskeleton will be tested to ensure smooth integration. Exoskeleton-assisted training will be conducted for no less than 1 hour per day (divided into two 30-minute sessions). Other rehabilitation interventions will be provided for at least 3 hours per day. Follow-ups will be conducted at 1, 2, 3, 6, and 12 months postoperatively.

Device: SCS+EXS

Interventions

SCS+EXS DEVICE

Eligible participants will undergo implantation of the spinal cord stimulation (SCS) system. Intraoperative electrophysiological monitoring will be used to adjust stimulation parameters. SCS will be tested postoperatively to assess the patient's tolerance to stimulation and its therapeutic effects. Parameters designed to improve sensory function and bladder/bowel control will be established. All parameters will be integrated into a sequential stimulation protocol. Additionally, the simultaneous activation of the SCS and the robotic exoskeleton will be tested to ensure smooth integration. Exoskeleton-assisted training will be conducted for no less than 1 hour per day (divided into two 30-minute sessions). Other rehabilitation interventions will be provided for at least 3 hours per day. Follow-ups will be conducted at 1, 2, 3, 6, and 12 months postoperatively.

SCS+EXS

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: March 18, 2025
• Study Start: October 13, 2024
• Primary Completion: January 1, 2026
• Study Completion: March 19, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

CN (1)