RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation

Technology

General health

Online since 2 May 2023, updated 350 days ago

About this trial

This trial is enrolling 3 individuals with chronic motor complete spinal cord injuries between T1 and L1 to test the feasibility of epidural spinal cord stimulation (SCS) in combination with robotic-assisted rehabilitation. Epidural SCS is a technique for stimulating the spinal cord with an implanted electrode placed next to the spinal cord to modify spinal cord function. If included, participants will undergo a 4-week rehabilitation session before device implantation. One month after surgery, participants will undergo 24 weeks of rehabilitation. Final safety assessments will be performed after 2 years.

Included participants

Gender

All

Age

≥ 21 years

Injury level

T2 - L1

Severity (AIS)?

AIS-A

AIS-B

Time since injury

≥ 1 year

Healthy volunteers

T2-L1

Additionally, participants must

Have preservation of some muscle reflexes below the level of injury

NOT have significant autonomic dysreflexia or orthostatic hypotension

What’s involved

Type

Technology

Details

- 4-week rehabilitation session before implanting the device. - Surgery for implanting the device next to the spinal cord. - One month after surgery, participants will undergo 24 weeks of rehabilitation. - Final safety assessments will be performed after 2 years.

Potential benefits

Main benefits

General health

Additional benefits

Standing/walking/mobility

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

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