Weight Bearing Over-ground Stepping in an Exoskeleton with Non-invasive Spinal Cord Neuromodulation after Motor Complete Paraplegia.
Parag Gad, Yury Gerasimenko, Sharon Zdunowski...
https://pubmed.ncbi.nlm.nih.gov/28642680Actively Recruiting
Phase Not Applicable
Age: 14Years - 65Years
All Genders
ID06939660
Spatiotemporal Spinal Cord Stimulation Based on Implantable Brain-machine Interfaces and Exoskeletons for Spinal Cord Injury (BASEGO)
Led by Xuanwu Hospital, Beijing · Updated on 2025-05-20
3
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
X
Xuanwu Hospital, Beijing
Lead Sponsor
B
Beijing Xinzhida Neural Technology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and technical feasibility of a new brain-machine interface (BCI)-assisted spinal cord stimulation (SCS) combined with an exoskeleton (EXS) system in adults aged 14 to 65 with chronic spinal cord injury (SCI). This study aims to determine if this system can safely and effectively improve lower limb motor function and quality of life in people who have had SCI for at least six months and have certain levels of motor impairment. Participants will receive implanted devices including high-density ECoG electrodes over the motor cortex and spinal cord stimulation electrodes at T11-L2. The system will be calibrated to synchronize the brain signals decoded by the BCI with the spinal cord stimulation and exoskeleton-assisted gait training. After implantation and calibration phases, participants will engage in daily one-hour training sessions, five times per week for one year, with ongoing adjustments to the system based on performance. Safety and efficacy will be assessed at multiple time points up to 12 months post-implantation. During the study, participants will be monitored through various assessments including motor function tests, neurophysiological measures, quality of life surveys, and device performance checks. Researchers will track adverse events and technical device data to evaluate safety. Follow-up visits will occur at 1, 2, 3, 6, and 12 months after device implantation. The study includes remote monitoring for device function and emergency support if needed, with a total participation time of at least one year.
CONDITIONS
Brief Title
BCI-Assisted SCS-EXS for Gait Optimization
Who Can Participate
Age: 14Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 14-65 years, any gender
- Diagnosed spinal cord injury (SCI) causing lower limb motor dysfunction
- Injury occurred at least 6 months ago with at least 1 month of conventional rehab without improvement in last 2 months
- ASIA Impairment Scale grade A, B, or C
- Good general health with life expectancy of at least 12 months
- Mini-Mental State Examination (MMSE) score of 22 or higher
- Completed secondary school education or above
- Willing to participate, provide informed consent, and comply with follow-up
You will not qualify if you...
- Other diseases affecting lower limb motor function such as brain diseases, vascular diseases, peripheral nerve or bone diseases
- Need for continuous medical support for vital functions like breathing or swallowing
- Structural abnormalities of lower limb bones or muscles
- Surgical contraindications including anesthesia risks or coagulation problems
- Presence of active implantable devices except certain SCS or BCI devices
- Unable to receive implants due to other treatments or MRI needs during implantation
- MRI or imaging showing significant brain motor area damage
- Severe cardiovascular disease or heart function below normal
- Blood clotting disorders or current blood-thinning treatments
- Severe recent infections or fever
- HIV, AIDS, active tuberculosis, or active hepatitis infections
- Recent severe cerebrovascular events or blood clots
- Metastatic or untreated cancers
- Recent major surgery or severe injuries
- Drug or alcohol abuse or uncontrolled mental health disorders
- Pregnant, breastfeeding, planning pregnancy, or women without reliable contraception
- Participation in other clinical trials within past month
- Cognitive impairments or inability to complete 12 months of follow-up and training
- Other conditions increasing study or device risk as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Initial implantation and calibration period
Participants undergo implantation of BCI electrodes over the motor cortex and spinal cord stimulation (SCS) electrodes, followed by system calibration to synchronize brain signals and spinal stimulation for gait assistance.
1 to 2 visits (in-person) for implantation and calibration
Treatment
Duration - Daily sessions, 60 minutes each, 5 times per week for 1 year
Participants engage in daily rehabilitation training sessions combining brain-controlled spinal cord stimulation and exoskeleton-assisted gait training to promote neuroplasticity and functional recovery.
5 training sessions per week for 12 months
Follow-Up
Duration - 12 months post-intervention
Participants attend safety and efficacy assessments at multiple time points after the intervention to monitor progress and device function.
Visits at 1, 2, 3, 6, and 12 months post-implantation
Trial Site Locations
Total: 1 location
1
Xuanwu Hospital ,Capital Medical University
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
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Research Team
P
Penghao Liu, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
The feasibility of using exoskeletal-assisted walking with epidural stimulation: a case report study.
Ashraf S Gorgey, Satinder Gill, Matthew E Holman...
https://pubmed.ncbi.nlm.nih.gov/32023011Activity-dependent spinal cord neuromodulation rapidly restores trunk and leg motor functions after complete paralysis.
Andreas Rowald, Salif Komi, Robin Demesmaeker...
https://pubmed.ncbi.nlm.nih.gov/35132264Walking naturally after spinal cord injury using a brain-spine interface.
Henri Lorach, Andrea Galvez, Valeria Spagnolo...
https://pubmed.ncbi.nlm.nih.gov/37225984Spatiotemporal spinal cord stimulation with real-time triggering exoskeleton restores walking capability: a case report.
Penghao Liu, Yuanchen Cheng, Zhuofan Xu...
https://pubmed.ncbi.nlm.nih.gov/39675019