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Clinical Trials in the USA / NCT07284823
Recruiting Not applicable

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

NCT07284823 · tracked via the Priya Life Science USA tracker
Sponsor
Cionic, Inc
Phase
Not applicable
Started
2025-12
Last updated
2025-12-18

Condition(s) studied

Parkinson Disease (PD)

Investigational drug(s) / intervention(s)

Cionic Neural Sleeve Multistim System

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.

Study summary

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

Eligibility

Sex
ALL
Min age
22 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of Participants Able to Independently Exit a Stimulation Program Using the Cionic Neural Sleeve — Day 0, Week 6, Week 12
    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.
  • Number of Participants Able to Independently Test Stimulation Using the Cionic Neural Sleeve — Day 0, Week 6, Week 12
    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).
  • Number of Participants Able to Independently Calibrate the Cionic Neural Sleeve System — Day 0, Week 6, Week 12
    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).
  • Safety of the Cionic Neural Sleeve — Day 0, Week 6, Week 12
    To understand the device's safety profile and potential side effects, researchers will record any adverse events during their home use.

Trial sites (2)

FacilityCityRegionStatus
Adapt Movement Carlsbad California Recruiting
CIONIC San Francisco California Recruiting

More Cionic, Inc. trials in the USA

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Tracking Self-Reported Functional Needs and Quality of Life Enrolling by invitation

Other trials for the same condition

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Pilot Trial Evaluating Patient Experience With the MemorEM for Patients With Neurological Diseases Enrolling by invitation
Safety, PK and Biodistribution of 18F-OP-801 in Patients With ALS, AD, MS, PD and Healthy Volunteers Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07284823 on ClinicalTrials.gov ↗ ← All trials in the USA