ExaStim for Spinal Cord Injury

Recruiting at 4 trial locations

Overseen By Yi-Kai Lo, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Niche Biomedical, Inc. dba ANEUVO

Must not be taking: Botox

Disqualifiers: Pregnancy, Obesity, Epilepsy, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a multi-center, observational, single-arm, 6-week home study to evaluate the safety and efficacy of transcutaneous spinal cord stimulation via the ExaStim system for 4 consecutive weeks used in the home setting for individuals with traumatic spinal cord injury. The study consists of a baseline evaluation and 1-week training period (Week 0), a 4-week stimulation period (Weeks 1-4), and a follow-up visit (Week 5), for a total expected duration of participation for each subject of six weeks.

Eligibility Criteria

This trial is for individuals over 22 years old who have had a traumatic spinal cord injury between C2 and T2, completed the ASPIRE clinical trial, and have limited upper limb function. They must be able to commit to a six-week study with caregiver support, internet access, and willingness to follow the protocol.

Inclusion Criteria

I or someone helping me can attend all clinic visits and follow the study plan.

I completed the ASPIRE clinical trial.

I have someone to help me with the device and paperwork.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Training

Baseline measurements and training for the use of ExaStim system

1 week

1 visit (in-person)

Treatment

Participants use the ExaStim system at home for 4 weeks with weekly telehealth check-ins

4 weeks

4 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

Treatment Details

Interventions

• ExaStim Stimulation System

Trial Overview The ExaStim Stimulation System is being tested for safety and effectiveness in improving arm function in people with spinal cord injuries. Participants will use the system at home for four weeks after initial training and evaluations.

Participant Groups

Group I: Transcutaneous Spinal Stimulation in the home setting Experimental Treatment 1 Intervention

Subjects will perform activities of daily living in conjunction with the ExaStim over a 4-week period in the home setting. In each session, subjects will receive stimulation while performing therapist-prescribed activities of daily living. Stimulation must be utilized for a maximum of 300 -minutes per week and a minimum of 125-minutes per week. The time spent using stimulation during home sessions, and the number of sessions that patients perform each week, is flexible and is intended to facilitate the use of ExaStim within each participant's daily routine.

Who Is Running the Clinical Trial?

Niche Biomedical, Inc. dba ANEUVO

Lead Sponsor

Trials

2

Recruited

40+