Cionic Neural Sleeve for ALS
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a device called the Cionic Neural Sleeve, designed to help people with ALS (a disease affecting nerve cells in the brain and spinal cord) improve their quality of life. Participants will wear the sleeve during exercise and walking, and researchers aim to assess its impact on daily activities. This trial may suit U.S. residents who are new customers awaiting the sleeve. However, individuals with certain heart devices, leg tumors, or leg injuries that could worsen with movement should not participate. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance daily living for ALS patients.
What prior data suggests that the Cionic Neural Sleeve System is safe for users with ALS?
Research shows that the Cionic Neural Sleeve is generally well-tolerated. This FDA-cleared device aims to improve leg movement, indicating it has undergone safety checks for other uses. Studies have found that the device can assist with walking and retraining muscles.
The device uses electrical signals to aid lower body muscles. Previous studies demonstrated positive effects, such as improved ankle movement, suggesting it is safe for individuals with mobility issues. Although every treatment carries some risks, current data on the Cionic Neural Sleeve is promising for human safety.12345Why are researchers excited about this trial?
Unlike the standard treatments for ALS, which typically include medications like Riluzole and Edaravone, the Cionic Neural Sleeve offers a unique approach by using a wearable device that provides stimulation assistance during exercise and walking sessions. This innovative method aims to enhance mobility and muscle function, which is a distinct shift from traditional drug therapies. Researchers are excited because this device has the potential to improve quality of life for ALS patients by directly assisting with movement in a non-invasive way.
What evidence suggests that the Cionic Neural Sleeve is effective for ALS?
Research shows that the Cionic Neural Sleeve can help people with neurological conditions move better. In one study, 94% of participants who wore the Neural Sleeve improved their walking ability, which is crucial for those with ALS, a disease affecting nerve cells in the brain and spinal cord. Another study found that participants improved their movement by an average of 9 degrees, making walking easier. The device uses electrical signals to assist muscles during walking, aiming to reduce stiffness and improve gait. This trial will evaluate the Cionic Neural Sleeve NS-200, with participants wearing the device and receiving stimulation assistance during exercise and walking sessions. These findings suggest the Cionic Neural Sleeve could help people with ALS move more easily and enhance their quality of life.12345
Are You a Good Fit for This Trial?
This trial is for U.S. residents who are new customers waiting to use the Cionic Neural Sleeve, designed for those with motor neuron diseases like ALS. It's not suitable for individuals with pacemakers, defibrillators, tumors or thrombosis in their legs, or leg fractures that could worsen with movement.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants will wear the Cionic Neural Sleeve NS-200 and receive stimulation assistance during exercise and walking sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cionic Neural Sleeve System
Trial Overview
The study tests the Cionic Neural Sleeve System on patients to see how it affects their daily functioning and quality of life. The sleeve is a wearable device aimed at assisting people with motor neuron conditions in moving more easily.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will wear the device and receive stimulation assistance during the exercise and walking sessions.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cionic, Inc.
Lead Sponsor
Citations
Cionic Neural Sleeve | Clinically Proven Results
Our gait assist trial demonstrated an average combined improvement of 9° across all participants. For full study results, review the original ...
2.
neurologylive.com
neurologylive.com/view/using-cionic-neural-sleeve-alleviate-gait-dysfunction-multiple-sclerosis-douglas-wajdaUsing the Cionic Neural Sleeve to Alleviate Gait ...
An early-stage study assessing the impacts of a functional electrical stimulation approach to treat gait problems in multiple sclerosis.
Cionic | Afferent White Paper
Explore Cionic's Afferent White Paper on the Neural Sleeve MultiStim System, showing reduced spasticity and improved gait for neurological ...
Impact of the Cionic Neural Sleeve on Mobility in Multiple ...
The randomized within-participants crossover 12-week study aims to demonstrate the clinical impact of the Cionic Neural Sleeve for individuals diagnosed ...
Cionic Neural Sleeve | FDA-Cleared Leg Mobility Device
In our multi-site study on fall risk, 94% of participants wearing the Neural Sleeve demonstrated an improvement in gait.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.