10 Participants Needed

Cionic Neural Sleeve for Parkinson's Disease

Recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Cionic, Inc.
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 trial tests a new wearable device called the Cionic Neural Sleeve, designed to assist people with Parkinson's disease who have difficulty walking. The goal is to determine if the sleeve is safe and easy to use while providing support during walking. Ideal participants have difficulty walking, own a smartphone, and can walk for at least one minute, even with assistance. It is not suitable for individuals who fall daily or have certain medical devices or conditions. As an unphased trial, this study allows participants to contribute to innovative research that could enhance mobility for those with Parkinson's disease.

What prior data suggests that the Cionic Neural Sleeve is safe for Parkinson's Disease?

Research has shown that the Cionic Neural Sleeve Multistim System aims to help people with Parkinson's Disease by using electrical signals to assist with walking. Although specific data about its safety in humans is not yet available, the trial focuses on testing the device's safety and ease of use. Early trials like this one typically aim to ensure treatments are safe and well-tolerated before advancing to more comprehensive studies. This trial seeks to confirm that the device is both safe and user-friendly for participants.12345

Why are researchers excited about this trial?

The Cionic Neural Sleeve is unique because it offers a wearable, non-invasive approach to managing Parkinson's disease symptoms. Unlike standard treatments like medication and deep brain stimulation that focus on altering brain chemistry or activity, this device provides direct stimulation assistance to improve walking. Researchers are excited because it could offer a new way to enhance mobility and quality of life for patients without the need for surgery or drug side effects.

What evidence suggests that the Cionic Neural Sleeve is effective for Parkinson's Disease?

Research has shown that the Cionic Neural Sleeve, used by participants in this trial, can help people with Parkinson's Disease move better. Studies have found that it improves the ability to lift the front part of the foot, aiding in walking by reducing "foot drop," a common issue in Parkinson's. The device also prevents the ankle from rolling inward. Early results suggest it can lessen stiffness in the lower body, making walking easier. These findings highlight its potential to improve mobility for those with Parkinson's.23467

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's Disease who have trouble walking but can still manage to walk for up to a minute, even if they need help from a device. They must fit the sleeve size and own a smartphone that works with the Cionic Neural Sleeve. People with leg fractures, daily falls, pacemakers or tumors in their legs cannot join.

Inclusion Criteria

Have access to a smartphone with iOS or Android operating system with Bluetooth capabilities and internet connection
Leg measurements within sizing range of the Cionic Neural Sleeve
I have difficulty walking.
See 1 more

Exclusion Criteria

I have a leg fracture or dislocation that could worsen with movement.
I experience falls every day.
Implanted demand-type cardiac pacemaker or defibrillator
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will wear the Cionic Neural Sleeve and receive stimulation assistance during walking

12 weeks
Visits at Day 0, Week 6, Week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cionic Neural Sleeve Multistim System

Trial Overview

The study is testing the Cionic Neural Sleeve Multistim System on people with Parkinson's Disease. It aims to see how safe it is and how easy it is for patients to use in their daily lives.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Cionic Neural Sleeve NS-200Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cionic, Inc.

Lead Sponsor

Trials
5
Recruited
130+

Citations

Safety and Usability of the Cionic Neural Sleeve ...

This research will investigate the safety and usability of the Cionic Neural Sleeve Multistim System for Parkinson's Disease. Official Title.

2.

trials.cionic.com

trials.cionic.com/

Trials

CIONIC is on a mission to increase mobility and independence for individuals living with motor impairments. We conduct clinical trials to study efficacy and ...

Parkinson's research study (California)

The study aims to understand the safety and usability of the Cionic Neural Sleeve for individuals with Parkinson's Disease. ... Multiple Sclerosis ...

4.

cionic.com

cionic.com/science

Cionic Neural Sleeve | Clinically Proven Results

Scientifically validated: Cionic Neural Sleeve improves ankle dorsiflexion and reduces inversion through adaptive stimulation—real-time gait ...

Cionic | Afferent White Paper

Cionic Neural Sleeve MultiStim System Demonstrates Reduction in Lower Extremity Spasticity in Combination with Triggered Functional Stimulation ...

Safety and Usability of the Cionic Neural Sleeve ...

This research will investigate the safety and usability of the Cionic Neural Sleeve Multistim System for Parkinson's Disease. Official Title.

CIONIC - We're launching a new clinical trial for people ...

The goal: understand and confirm the safety and usability of the Neural Sleeve for individuals with Parkinson's. Interested in participating ...