30 Participants Needed

ExaStim for Spinal Cord Injury

Recruiting at 4 trial locations
LM
YL
Overseen ByYi-Kai Lo, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Niche Biomedical, Inc. dba ANEUVO
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Are You a Good Fit for This Trial?

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.
See 7 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Transcutaneous Spinal Stimulation in the home settingExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Niche Biomedical, Inc. dba ANEUVO

Lead Sponsor

Trials
2
Recruited
40+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
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