ExaStim for Spinal Cord Injury

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new device, the ExaStim Stimulation System, for people with traumatic spinal cord injuries. The device stimulates the spinal cord and will be used at home while participants engage in daily activities over four weeks. The trial seeks participants who have completed the ASPIRE trial, have limited arm function due to their injury, and need assistance with daily tasks.

As an unphased trial, participants can contribute to groundbreaking research that may improve daily living for those with spinal cord injuries.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the ExaStim system is safe for individuals with spinal cord injury?

Research has shown that the ExaStim Stimulation System is generally easy to use without problems. In a study with this system, researchers found no serious side effects, indicating that the treatment is likely safe for home use. Participants used ExaStim for a few weeks without major issues. This evidence suggests that individuals with spinal cord injuries can safely use ExaStim. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The ExaStim Stimulation System is unique because it offers a non-invasive, at-home approach to spinal cord injury rehabilitation through transcutaneous spinal stimulation. Unlike traditional treatments that often require in-clinic visits or invasive procedures, ExaStim allows patients to incorporate therapy into their daily routines, providing flexibility and convenience. Researchers are excited because this method could enhance the ease and effectiveness of rehabilitation, making consistent therapy more accessible and potentially leading to improved functional outcomes for patients.

What evidence suggests that the ExaStim Stimulation System is effective for spinal cord injury?

Research has shown that the ExaStim Stimulation System could benefit people with spinal cord injuries. One study found that participants using ExaStim improved their upper limb function by an average of 6 points. Early results also indicate enhanced hand and arm abilities when combined with therapy. Additionally, another study demonstrated improved upper body function in all participants. In this trial, participants will use the ExaStim Stimulation System at home to perform daily activities, which may help restore movement and function for those with spinal cord injuries. ^{1 2 3 4 5}

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.

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?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999322018160

A Pilot Study Using ExaStim to Restore Upper Limb ... Nine participants treated with ExaStim experienced a median increase in ISNCSCI UEMS total score of 6.0 points from the baseline. For the Neurological Level of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06850363

ExaStim Upper Limb Home Use Clinical Validation Study 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 ...

3. aneuvo.com aneuvo.com/us/healthcare-professionals/exastim-tss-therapy/

ExaStim Stimulation System ExaStim is being evaluated for safety and effectiveness in ongoing clinical studies – with early promising results for people living with spinal cord injuries.

4. rally.massgeneralbrigham.org rally.massgeneralbrigham.org/study/aspire

Regain Function and Restore Life after Upper Limb ... Preliminary results have shown that ExaStim together with therapy could improve hand and arm function after SCI. This new portable transcutaneous spinal cord ...

5. neurology.org neurology.org/doi/10.1212/CPJ.0000000000200537

Home-Based Noninvasive Spinal Cord Stimulation Safely ... All 7 individuals experienced improved upper extremity function, with 2 improving their American Spinal Injury Association Impairment Scale (AIS) ...