Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07284823

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Parkinson Disease (PD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

22 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adapt Movement, Carlsbad, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cionic Neural Sleeve Multistim System

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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).

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

    Time frame: 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).

  4. Safety of the Cionic Neural Sleeve

    Time frame: 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.

Other outcomes

  1. Qualitative Feedback on Stimulation Timing

    Time frame: Day 0, Week 6, Month 3

    Qualitative feedback regarding stimulation timing during gait will be collected every 6 weeks using structured interviews. Data will be used to assess user experience and perceived synchronization between stimulation delivery and functional movement.

  2. Usability of the Cionic Neural Sleeve

    Time frame: Week 12

    Usability of the Cionic Neural Sleeve will be evaluated using the 10-item System Usability Scale with total scores ranging from 0 to 100. Scores greater than or equal to 68 indicate above-average usability.

  3. Impact of the Cionic Neural Sleeve

    Time frame: Day 0, Week 6, Week 12

    The Timed Up and Go (TUG) test will be used to assess functional mobility. Participants are instructed to stand up from a chair, walk 3 meters, turn around, return to the chair, and sit down. The total time to complete the task is recorded in seconds, with shorter times indicating better mobility. A minimum clinically important difference (MCID) of 0.77 seconds will be used to interpret meaningful change in performance over time.

Sponsors and collaborators

Lead sponsor

Cionic, Inc.

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.