Spinal Cord Stimulation (SCS) for Spinal Cord Injury (SCI)

Technology

Pain

Online since 11 November 2021, updated 1063 days ago

About this trial

This is a trial to test the safety and effectiveness of spinal cord stimulation on pain and muscle function after spinal cord injury. If included, participants will undergo surgery for implantation of a stimulation device next to the spinal cord (epidural). Participants will then receive 9 months of conventional medical and rehabilitation management with either: 1) spinal cord stimulation turned on; or 2) spinal cord stimulation turned off (no stimulation). Participants will not know which group they are in until the end of the 9 months. At the end of the 9 months, participants who were in the spinal cord stimulation off group (no stimulation) can have their spinal cord stimulator turned on.

Included participants

Gender

All

Age

22 - 65 years

Injury level

T1 - T12

Severity (AIS)?

AIS-A

Time since injury

1 year - 5 years

Injury type

Traumatic

Healthy volunteers

T1-T12

Additionally, participants must

have chronic pain (i.e., pain for more than 3 months, on more than 50% of the days)

be able to undergo MRI (no implanted metallic devices)

What’s involved

Type

Technology

Details

Participants will undergo surgery for implantation of the stimulation device next to the spinal cord. Participants will receive 9 months of conventional medical and rehabilitation management with either: 1) spinal cord stimulation turned on; or 2) spinal cord stimulation turned off (no stimulation). At the of the 9 months, the sham group will also be able to turn on SCS. Final testing will be performed after 9 months.

Potential benefits

Main benefits

Pain

Additional benefits

Arm/hand function

Bladder health/function

General health

Mental health and psychosocial factors

Sensory function

Spasticity

Standing/walking/mobility

Mechanism of action

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

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Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

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