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

Cionic

Status: Enrolling

Conditions: Parkinson Disease (PD)

Treatments: Device: Cionic Neural Sleeve Multistim System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07284823

CIONIC-08-001

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 22 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Cionic Neural Sleeve NS-200

Experimental group

Description:

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

Treatment:

Device: Cionic Neural Sleeve Multistim System