STIMO: Epidural Electrical Simulation (EES) With Robot-assisted Rehabilitation in Patients With Spinal Cord Injury.

Technology

Standing/walking/mobility

Online since 25 September 2021, updated 923 days ago

About this trial

This trial is recruiting individuals with chronic incomplete spinal cord injuries to test using an implanted electrical stimulation device in combination with overground robot assisted rehabilitation training. The main goal is to test if the stimulation (closed-loop Epidural Electrical Stimulation -EES) with walking training (body weight support system - BWSS) is safe and can improve walking. The study lasts about 8-12 months for each participant. Each will be evaluated before the EES is implanted, train with BWSS while optimizing EES for a period of 5-6 months, with the option to continue training with a home-use system for up to 3 years.

Included participants

Gender

All

Age

18 - 65 years

Injury level

C1 - T10

Severity (AIS)?

AIS-C

AIS-D

Time since injury

12 months - 65 years

Injury type

Traumatic

Healthy volunteers

C1-T10

Additionally, participants must

have had an injury for at least 12 months and completed an in-patient rehabilitation program.

Have neurological level of injury between C1 and T10.

ASIA impairment scale (AIS) is one of the following:

What’s involved

Type

Technology

Details

6-8 weeks before EES implantation surgery: 6 days of tests (5 in Lausanne and 1 in Zurich), followed by 3 weeks of BWSS training. EES implantation surgery and EES customization over 6-8 weeks when the participant will need to be present at CHUV University Hospital in Lausanne for 4-5 days per week. BWSS training with EES, 4 days per week for 5 months at CHUV University Hospital in Lausanne. The final tests will last 5 days (4 in Lausanne and 1 in Zurich). After the study, there will be an option to continue with a home-use system for up to 3 years.

Potential benefits

Main benefits

Standing/walking/mobility

Additional benefits

Arm/hand function

General health

Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

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