Safety and Usability of the Cionic Neural Sleeve for Parkinson's Disease

NCT ID: NCT07284823

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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Conditions

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Parkinson Disease (PD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cionic Neural Sleeve NS-200

Participants will wear the device during the study and receive stimulation assistance during walking.

Group Type EXPERIMENTAL

Cionic Neural Sleeve Multistim System

Intervention Type DEVICE

The sleeve assists participants during physical activity by delivering electrical stimulation that helps contract the necessary muscles at the correct time to improve movement.

Interventions

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Cionic Neural Sleeve Multistim System

The sleeve assists participants during physical activity by delivering electrical stimulation that helps contract the necessary muscles at the correct time to improve movement.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Self-reported gait impairment
* Have access to a smartphone with iOS or Android operating system with Bluetooth capabilities and internet connection
* Ability to walk with or without an assistive device for up to 1 minute
* Leg measurements within sizing range of the Cionic Neural Sleeve

Exclusion Criteria

* Daily occurrence of falls
* Implanted demand-type cardiac pacemaker or defibrillator
* Malignant tumor or existing thrombosis in the leg
* Fracture or dislocation in the leg that could be adversely affected by motion from stimulation
Minimum Eligible Age

22 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cionic, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Rebecca Webster

Clinical Operations Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Adapt Movement

Carlsbad, California, United States

Site Status RECRUITING

CIONIC

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Adam Heredia, EdD

Role: primary

Rebecca Webster, PhD

Role: primary

Other Identifiers

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CIONIC-08-001

Identifier Type: -

Identifier Source: org_study_id