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

Cionic, Inc.10 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Parkinson Disease (PD)

Interventions

Cionic Neural Sleeve Multistim SystemDEVICE

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

Eligibility

Sex: ALLMin age: 22 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

Adapt Movement

Carlsbad, California, United States

RECRUITING

CIONIC

San Francisco, California, United States

RECRUITING

Outcomes

Primary Outcomes

Number of Participants Able to Independently Exit a Stimulation Program Using the Cionic Neural Sleeve

Participants' ability to independently exit (terminate) an active stimulation program on the Cionic Neural Sleeve will be assessed during study visits. Independence is defined as successful completion of the task without verbal cueing or physical assistance from study staff. Study staff will document whether the participant is able to exit the program independently (yes/no) at each visit.

Time frame: Day 0, Week 6, Week 12

Number of Participants Able to Independently Test Stimulation Using the Cionic Neural Sleeve

Participants' ability to independently initiate and test stimulation on the Cionic Neural Sleeve will be assessed during study visits. Successful task completion is defined as the participant correctly activating stimulation and confirming perception of stimulation without assistance. Study staff will document successful independent testing (yes/no).

Time frame: Day 0, Week 6, Week 12

Number of Participants Able to Independently Calibrate the Cionic Neural Sleeve System

Participants' ability to independently complete device calibration of the Cionic Neural Sleeve system will be assessed during study visits. Calibration is defined as completion of the device-guided calibration procedure without verbal or physical assistance. Study staff will document successful independent calibration (yes/no).

Time frame: Day 0, Week 6, Week 12

Safety of the Cionic Neural Sleeve

To understand the device's safety profile and potential side effects, researchers will record any adverse events during their home use.

Time frame: Day 0, Week 6, Week 12

Data from ClinicalTrials.gov

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