Assessment of the Efficacy and Safety of EESS in Patients With Incomplete Spinal Cord Injuries

Technology

Standing/walking/mobility

Online since 5 November 2021, updated 1281 days ago

About this trial

This is a clinical trial investigating the safety and effect of spinal cord stimulation combined with rehabilitation on individuals with chronic, incomplete spinal cord injury. The method being tested, electric epidural spinal cord stimulation (EESS), modifies spinal cord function by way of electrodes implanted on the spinal cord. Researchers want to see if the electrodes activate nerve networks in the spinal cord. The effects of stimulation will be measured mainly in terms of walking function, but also by urological and sexual function, as well as quality of life factors. If included in the trial, participants will undergo 40 days of rehabilitation with the stimulation and 40 days without the stimulation. After the first 40 days of rehabilitation, participants will rest for 30 days before completing 40 more days of rehabilitation. The order in which participants complete rehabilitation with or without the stimulation will be randomized (not in predetermined order).

Included participants

Gender

All

Age

18 - 65 years

Injury level

C1 - T10

Severity (AIS)?

AIS-B

AIS-C

Time since injury

2 years - 65 years

Injury type

Traumatic

Healthy volunteers

C1-T10

Additionally, participants must

have little or no motor deficit of the upper limbs (upper limb muscle scores ≥ 4/5)

NOT have contraindication to MRI, e.g. implanted device such as pacemaker

What’s involved

Type

Technology

Details

Participation in a rehabilitation program for 40 days, a break of 30 days and another rehabilitation program of 40 days The rehabilitation program consists of 2 daily sessions of 45 minutes It is not clear if surgery is required. The information provided suggests that before the first rehabilitation program begins, participants will have back surgery. During the surgery, electrodes will be placed on the spinal cord. During the rehabilitation program with stimulation, the stimulation intensity will be individually adapted. Participants will complete a series of walking, quality of life, bladder function, and sexual function tests several times. It is not clear how often these tests will be completed. Assessment of bladder function will use cystometry, which requires inserting a catheter into the bladder. It is not clear how long the study lasts.

Potential benefits

Main benefits

Standing/walking/mobility

Additional benefits

Bladder health/function

General health

Mental health and psychosocial factors

Sexual health

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

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