Neuroprosthesis for Paralysis

(LE-IST Trial)

Recruiting at 1 trial location

Overseen By Maura Malenchek, PTA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Disqualifiers: Obesity, Immunodeficiency, Diabetes, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate exercise, standing, stepping and/or balance in people with various degrees of paralysis.

Will I have to stop taking my current medications?

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.

Is the neuroprosthesis for paralysis generally safe for humans?

Functional electrical stimulation (FES) has been researched for over 40 years, establishing principles for safe use in neuromuscular applications. It has been used in various systems to restore function in different body parts, and some have become commercial products, indicating a level of safety in humans. ^{1 2 3 4 5}

How is the IST-16 treatment for paralysis different from other treatments?

The IST-16 treatment, also known as a Functional Electrical Stimulation (FES) system, is unique because it uses electrical currents to stimulate paralyzed muscles, allowing them to function again. This approach is different from other treatments as it involves wearing small electronic devices that patients can control to help them stand, walk, or perform other movements, which is not typically possible with standard therapies for paralysis. ^{2 4 5 6 7}

What data supports the effectiveness of the treatment IST-16, Advanced Lower Extremity Neuroprostheses, Functional Electrical Stimulation (FES) System for paralysis?

Research shows that Functional Electrical Stimulation (FES) can help paralyzed muscles contract, allowing people with spinal cord injuries to stand and walk short distances. It has been used successfully in patients with different levels of paralysis, improving their ability to perform activities like standing and walking. ^{1 2 5 6 7}

Who Is on the Research Team?

Ronald J Triolo, Ph.D.

Principal Investigator

Case Western Reserve University

Musa L Audu, Ph.D.

Principal Investigator

Louis Stokes Cleveland VA Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with paralysis due to spinal cord injury or conditions like stroke, who've been affected for over 6 months. They should have some intact nerve function and be able to move their joints normally. People with heart issues, pregnancy, joint contractures, severe lung/kidney/blood circulation problems, uncontrolled seizures or psychological issues, obesity, drug abuse, immune deficiencies or frequent infections can't join.

Inclusion Criteria

Your bones have finished growing.

I can move all my joints normally.

Ability to understand and sign informed consents

Exclusion Criteria

Pregnancy

I have seizures that my current medication cannot control.

I am considered obese.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo surgery for electrode implantation and initial recovery

4-6 weeks

Post-operative Training

Training in standing, transfers, and advanced mobility skills using the FES system

8-12 weeks

Home-based Training

Participants engage in home-based training prior to discharge for home use of the system

4-8 weeks

Follow-up

Participants are monitored for device reliability and technical performance at 6 and 12 months after discharge, and annually thereafter

12 months

What Are the Treatments Tested in This Trial?

Interventions

• IST-16

Trial Overview The study tests an implanted device called IST-16 that uses electrical stimulation to help people with paralysis exercise and improve movement like standing or stepping. It's surgically placed in the body and aims to restore some mobility functions.

How Is the Trial Designed?

Group I: Implant Experimental Treatment 1 Intervention

Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures.

IST-16 is already approved in United States, European Union for the following indications:

Approved in United States as IST-16 for:

• Paralysis
• Spinal Cord Injury
• Muscle Weakness

Approved in European Union as IST-16 for:

• Paralysis
• Spinal Cord Injury
• Muscle Weakness

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+

Published Research Related to This Trial

The functional electrical stimulation (FES) system for helping spinal cord injured patients walk includes adjustable components like muscle stimulators and a gait orthosis, allowing for personalized configurations for each patient.

The electrode delivery system, which is a key part of the FES setup, has been successfully used on patients with different levels of spinal cord injury, demonstrating its effectiveness in facilitating ambulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systems approach to medically prescribed functional electrical stimulation. Ambulation after spinal cord injury. Phillips, CA., Hendershot, DM.[2004]

A T6 ASIA B paraplegic subject successfully used the Case Western Reserve Neuroprosthesis to stand for nearly 3 minutes and walk 35 feet, demonstrating the potential of functional electric stimulation (FES) for improving mobility in spinal cord injury patients.

The study highlighted limitations such as the walking speed of 5.8 m/min and muscle fatigue, indicating that further improvements are needed for practical use in everyday settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the Case Western Reserve/Veterans Administration neuroprosthesis for exercise, standing and transfers by a paraplegic subject. Forrest, GP., Smith, TC., Triolo, RJ., et al.[2012]

Functional electrical stimulation (FES) is an innovative rehabilitation technique that allows paralyzed patients to regain some control over their extremities by using small electronic stimulators to activate their muscles.

Recent advancements in FES include both single- and multi-channel stimulation methods, showing promise in improving functionality in both the legs and upper extremities of patients with paralysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation of the extremities: part 1. Kralj, A., Vodovnik, L.[2019]

In a trial involving 44 participants with secondary progressive multiple sclerosis, those receiving exercise therapy showed significant improvements in walking speed and endurance compared to those using functional electrical stimulation (FES).

While FES did not improve walking performance without stimulation, it provided an orthotic benefit during stimulation, suggesting that combining FES with exercise may enhance overall therapeutic effects for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial to investigate the effects of functional electrical stimulation and therapeutic exercise on walking performance for people with multiple sclerosis. Barrett, CL., Mann, GE., Taylor, PN., et al.[2022]

Functional electrical stimulation (FES) can effectively induce muscle contractions in paralyzed or weak muscles by applying electrical currents to the intact peripheral motor nerves, providing a means to restore function in various body systems.

Over 40 years of research have led to the development of safe and effective FES systems for different applications, with ongoing technological advancements promising more integrated and versatile neuroprosthetic devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation for neuromuscular applications. Peckham, PH., Knutson, JS.[2022]

The study introduces a real-time functional electrical stimulation (FES) system that uses electromyography (eEMG) signals to predict joint torque, which is crucial for personalized rehabilitation in spinal cord injury (SCI) patients.

Testing on 3 able-bodied subjects and 3 SCI patients showed that both the Kalman filter and recurrent neural network (RNN) methods effectively estimated joint torque, with RNN being more computationally efficient, indicating potential for practical use in personalized neuroprosthetic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time estimation of FES-induced joint torque with evoked EMG : Application to spinal cord injured patients. Li, Z., Guiraud, D., Andreu, D., et al.[2019]

The implanted functional electrical stimulation (FES) neuroprosthesis demonstrated the ability to restore lower limb motor functions in a patient with spinal cord injury over a 9-year follow-up, highlighting its long-term efficacy.

However, the study revealed challenges such as muscle fatigue and the need for regular use and strength training to maintain muscle response and gait performance, indicating the importance of ongoing clinical monitoring and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implanted functional electrical stimulation: case report of a paraplegic patient with complete SCI after 9 years. Guiraud, D., Azevedo Coste, C., Benoussaad, M., et al.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

A systems approach to medically prescribed functional electrical stimulation. Ambulation after spinal cord injury. [2004]

2. England pubmed.ncbi.nlm.nih.gov

Use of the Case Western Reserve/Veterans Administration neuroprosthesis for exercise, standing and transfers by a paraplegic subject. [2012]

3. England pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation of the extremities: part 1. [2019]

4. England pubmed.ncbi.nlm.nih.gov

A randomized trial to investigate the effects of functional electrical stimulation and therapeutic exercise on walking performance for people with multiple sclerosis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation for neuromuscular applications. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Real-time estimation of FES-induced joint torque with evoked EMG : Application to spinal cord injured patients. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Implanted functional electrical stimulation: case report of a paraplegic patient with complete SCI after 9 years. [2021]