Actively Recruiting
Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation
Led by Ecole Polytechnique Fédérale de Lausanne · Updated on 2026-06-08
3
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the preliminary safety and effectiveness of using a brain-controlled spinal cord stimulation device to restore voluntary movement in people with chronic stroke who have mobility impairments. The study focuses on establishing a direct connection between the participant's motor intentions and spinal cord stimulation to improve or restore control of arm and leg movements and support neurological recovery when combined with rehabilitation. Participants will receive an implantable device called the ARC-BSI Stroke system, which includes a 64-channel electrocorticogram (ECoG) array placed over the motor cortex and two 16-channel spinal cord stimulation systems implanted over the cervical and lumbar regions. The brain signals decoded by the ECoG control the spinal cord stimulation in real time to assist with training and rehabilitation aimed at recovering voluntary movements. During the study, participants will undergo assessments before implantation and at multiple points after surgery, including 6 months, 1 year, and then yearly up to 5 years. Outcome measures include safety monitoring and evaluations of motor function, walking ability, muscle strength, spasticity, and neurological recovery using standardized tests and gait analyses. Participants are expected to attend all scheduled visits and comply with study procedures over the 5-year period.
CONDITIONS
Brief Title
Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years at enrollment
- Stroke affecting subcortical or brain stem areas occurred between 9 months and 10 years before enrollment
- Fugl-Meyer upper-limb score lower than 25
- Ability to stand for 30 seconds with or without an assistive device
- Montreal Cognitive Assessment score higher than 22
- Presence of right or left hemiplegia
- Completion of primary standard rehabilitation
- Signed informed consent before study procedures
- Ability to communicate in French or English
- Agreement to comply with study conditions and attend all visits
- Use of effective contraception for women able to bear children
- Ability to stop antiplatelet or anticoagulation medication during surgeries if needed
You will not qualify if you...
- Pregnancy or breastfeeding
- Intention to become pregnant during the study
- Medical conditions increasing risk of surgery complications
- Mental health disorders such as personality disorder, psychosis, substance abuse, or severe depression
- Other medical conditions preventing participation (e.g., major cognitive disorder, kidney or liver failure, epilepsy)
- Significant swallowing difficulties or need for ventilator support
- Presence of active implanted devices like pacemakers or neurostimulators
- Spinal abnormalities or incompatibilities preventing surgery
- Severe limb spasticity (Modified Ashworth Scale greater than 3)
- Need for frequent MRI scans
- Participation in other interfering clinical studies
- Investigator or related persons involved in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants receive implantation of a 64 channel electrocorticogram (ECoG) array over the sensory motor cortex and two 16 channel spinal cord stimulation systems over cervical and lumbar regions. The brain-controlled spinal cord stimulation is used for training and rehabilitation to recover voluntary movements of the upper and lower limbs.
Multiple visits for implantation and rehabilitation sessions over the study duration
Duration - 5 years
Participants undergo periodic assessments to evaluate neurological recovery and functional improvements through various motor function tests and scales at baseline, 6 months, 1 year, and yearly up to 5 years post-implantation.
Assessments lasting 1 to 2 weeks at Baseline, 6 months, 1 year, and annually up to 5 years
Trial Site Locations
Total: 1 location
1
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1005
Actively Recruiting
Research Team
J
Jocelyne Bloch, MD
H
Henri Lorach, PhD
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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