Neuroprosthesis for Paralysis
(LE-IST Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen ByRonald J Triolo, Ph.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Case Western Reserve University
Disqualifiers: Obesity, Immunodeficiency, Diabetes, others
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
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.
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.
12345Is 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.
24567How 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.
12347Eligibility Criteria
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
+4 more
Exclusion Criteria
Pregnancy
I have seizures that my current medication cannot control.
I am considered obese.
+13 more
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: ImplantExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MetroHealth SystemCleveland, OH
Louis Stokes Cleveland VA Medical CenterCleveland, OH
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Who Is Running the Clinical Trial?
Case Western Reserve UniversityLead Sponsor
National Institutes of Health (NIH)Collaborator
US Department of Veterans AffairsCollaborator
References
A systems approach to medically prescribed functional electrical stimulation. Ambulation after spinal cord injury. [2004]A functional electrical stimulation (FES) system for ambulation of spinal cord injured patients has been described to consist of physician prescriptable, commercially available components. The system components are: electrical muscle stimulators, a reciprocating gait orthosis and the electrode delivery system. A systems approach to medically prescribed FES ambulation requires the interfacing of these basic components, each of which has the flexibility to adjust to the optimal configuration for each individual patient. The electrode delivery system is of central importance in interfacing the basic components. This report describes the electrode delivery system, a transcutaneous transducer garment, which allows a variety of electrode configurations and stimulation patterns. The system has been successfully employed on a C7 level tetraplegic patient and a T9 level paraplegic patient.
Use of the Case Western Reserve/Veterans Administration neuroprosthesis for exercise, standing and transfers by a paraplegic subject. [2012]Functional electric stimulation (FES) is a technology that may allow patients with spinal cord injury (SCI) to transfer stand and walk. This paper reports upon the use of the Case Western Reserve Neuroprosthesis by a T6 ASIA B paraplegic subject. The subject was able to stand for two minutes and 50 seconds. He could walk 35 feet with a swing to gait. Measurement of energy consumption showed that metabolic demand was only 2.1 metabolic equivalent units. The factors that limited the use of the device that need to be improved to make the technology practical for household or community ambulation are speed (5.8 m/min) of ambulation and fatigue of the stimulated muscles.
Functional electrical stimulation of the extremities: part 1. [2019]Functional electrical stimulation of the extremities (FES) is a new method for the rehabilitation of paralysed paretic patients. Small, electronic stimulators are worn by the patient, who can voluntarily control the electrical currents applied to his paralysed muscle. These currents activate the disabled extremities and make them at least partially functional once more. This paper presents a short history of FES and discusses recent advances and problems in the field. A detailed account of present work with single- and multi-channel stimulation of paralysed legs is given, as well as some research data on upper extremity stimulation.
A randomized trial to investigate the effects of functional electrical stimulation and therapeutic exercise on walking performance for people with multiple sclerosis. [2022]Functional electrical stimulation (FES), is a means of producing a contraction in a paralyzed or weak muscle to enable function through electrical excitation of the innervating nerve.
Functional electrical stimulation for neuromuscular applications. [2022]Paralyzed or paretic muscles can be made to contract by applying electrical currents to the intact peripheral motor nerves innervating them. When electrically elicited muscle contractions are coordinated in a manner that provides function, the technique is termed functional electrical stimulation (FES). In more than 40 years of FES research, principles for safe stimulation of neuromuscular tissue have been established, and methods for modulating the strength of electrically induced muscle contractions have been discovered. FES systems have been developed for restoring function in the upper extremity, lower extremity, bladder and bowel, and respiratory system. Some of these neuroprostheses have become commercialized products, and others are available in clinical research settings. Technological developments are expected to produce new systems that have no external components, are expandable to multiple applications, are upgradable to new advances, and are controlled by a combination of signals, including biopotential signals from nerve, muscle, and the brain.
Real-time estimation of FES-induced joint torque with evoked EMG : Application to spinal cord injured patients. [2019]Functional electrical stimulation (FES) is a neuroprosthetic technique for restoring lost motor function of spinal cord injured (SCI) patients and motor-impaired subjects by delivering short electrical pulses to their paralyzed muscles or motor nerves. FES induces action potentials respectively on muscles or nerves so that muscle activity can be characterized by the synchronous recruitment of motor units with its compound electromyography (EMG) signal is called M-wave. The recorded evoked EMG (eEMG) can be employed to predict the resultant joint torque, and modeling of FES-induced joint torque based on eEMG is an essential step to provide necessary prediction of the expected muscle response before achieving accurate joint torque control by FES.
Implanted functional electrical stimulation: case report of a paraplegic patient with complete SCI after 9 years. [2021]Experience of an implanted functional electrical stimulation neuroprosthesis (FES) associating 8-channel epimysial and 4-channel neural stimulations. The primary objective consisted in presenting clinical and technological experiences based on a 9-year follow-up of one patient implanted with this FES device. The secondary objective consisted in assessing resulting functional benefits.