Restoration of Hand Function in Cervical SCI

Technology

Arm/hand function

Online since 15 March 2025, updated 115 days ago

About this trial

This trial is enrolling 20 participants with chronic cervical spinal cord injury to test the feasibility and evaluate the impact of an implantable peripheral nerve stimulator on hand function. The device, KeyGrip, is intended to cause contraction of weakened or paralyzed muscles through low level electrical stimulation. If included, participants will undergo a surgical procedure to implant the KeyGrip system in the forearm. Final testing of hand function and device efficacy will be performed after 1 year. Following completion of the study, the device will remain in the body unless the participant chooses to have it surgically removed.

Included participants

Gender

All

Age

≥ 18 years

Injury level

C1 - C7

Severity (AIS)?

AIS-A

AIS-B

AIS-C

Time since injury

≥ 6 months

Injury type

Traumatic

Healthy volunteers

C1-C7

Additionally, participants must

NOT have an active implantable medical device such as a pacemaker or defibrillator

What’s involved

Type

Technology

Details

- Participants will undergo a single surgical procedure, lasting up to 90 minutes, to implant the KeyGrip system. This procedure involves placing a receiver in the forearm, connected by tunneled wires to stimulating electrodes in the hand or arm muscles. - KeyGrip is intended to cause contraction of weakened or paralyzed muscles through electrical stimulation. - Participants will control the stimulation via a phone app, which communicates with an external power unit over the implanted receiver. - Final testing of hand function and device efficacy will be performed after 1 year.

Potential benefits

Main benefits

Arm/hand function

Additional benefits

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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