Noninvasive Spinal Cord Stimulation for Early SCI

Technology

Bladder health/function

Online since 25 January 2025, updated 5 days ago

About this trial

This trial is enrolling 60 participants with subacute spinal cord injury (3–6 months post-injury) to test the effect of transcutaneous spinal cord stimulation (SCS) on bladder function. SCS is a technique for stimulating the spinal cord via surface electrodes to modify spinal cord function. If included, participants will receive either 8 weeks of therapeutic SCS using the SCONE™ device, or 8 weeks of sham stimulation, each combined with conventional rehabilitation. The therapy group will then continue SCS for another 8 weeks. The sham group will crossover to receive 8 weeks of SCS. Final testing of bladder function will be performed after 33 weeks.

Included participants

Gender

All

Age

19 - 65 years

Injury level

C5 - T10

Severity (AIS)?

AIS-A

AIS-B

Time since injury

3 months - 6 months

Healthy volunteers

C5-T10

Additionally, participants must

NOT have an implanted cardiac pacemaker, implanted metal in the trunk or spinal cord, intrathecal delivery system (e.g., baclofen pump), or implanted central or peripheral neuromodulator

What’s involved

Type

Technology

Details

- Participants will receive 8 weeks of transcutaneous spinal cord stimulation (SCS) and 8 weeks of sham stimulation using the SCONE™ device, delivered in random order, each combined with conventional rehabilitation. - SCS is a technique for stimulating the spinal cord via surface stimulation to modify spinal cord function. - Final testing of bladder function will be performed after 33 weeks.

Potential benefits

Main benefits

Bladder health/function

Additional benefits

Bowel health

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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