ExaStim Upper Limb Home Use Clinical Validation Study

Technology

Arm/hand function

Online since 20 May 2025, updated 7 days ago

About this trial

This trial is enrolling 30 participants with traumatic spinal cord injury who participated in the original study using a transcutaneous spinal stimulation (tSS) device (ExaStim) to test the safety and feasibility of tSS in the home setting. tSS is a non-invasive technique that uses skin surface electrodes placed over the spinal to deliver electrical stimulation aimed at modifying spinal cord function. If included, participants will undergo 4 weeks of home-based stimulation therapy using ExaStim. While receiving tSS, they will perform therapist-prescribed activities of daily living or home exercises. Final testing of safety and feasibility will be performed after 6 weeks.

Included participants

Gender

All

Age

≥ 22 years

Injury level

C2 - T2

Severity (AIS)?

AIS-A

AIS-B

AIS-C

AIS-D

Time since injury

≥ 6 months

Injury type

Traumatic

Healthy volunteers

C2-T2

Additionally, participants must

NOT have an active implanted medical device for electrical stimulation

have completed the ASPIRE clinical trial

What’s involved

Type

Technology

Details

- Participants will undergo a 1-week training phase followed by 4 weeks of home-based stimulation therapy using the ExaStim system. - ExaStim is a device that delivers transcutaneous spinal stimulation (tSS); a non-invasive technique that uses surface electrodes to deliver electrical stimulation aimed at modifying spinal cord function. - While receiving tSS, they will perform therapist-prescribed activities of daily living or home exercises for 125 to 300 minutes per week. - Final testing of safety and feasibility will be performed after 6 weeks.

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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