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

December 17, 2025 updated by: Rebecca Webster, Cionic, Inc.
This research will investigate the safety and usability of the Cionic Neural Sleeve Multistim System for Parkinson's Disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Carlsbad, California, United States, 92010
        • Recruiting
        • Adapt Movement
        • Contact:
      • San Francisco, California, United States, 94111
        • Recruiting
        • CIONIC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cionic Neural Sleeve NS-200
Participants will wear the device during the study and receive stimulation assistance during walking.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0, Week 6, Week 12
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).
Day 0, Week 6, Week 12
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).
Day 0, Week 6, Week 12
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.
Day 0, Week 6, Week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0, Week 6, Month 3
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.
Week 12
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.
Day 0, Week 6, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cionic, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 9, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Estimated)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIONIC-08-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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