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

NCT07284823 | Recruiting FDA Device

• 1 other identifier: CIONIC-08-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Parkinson Disease (PD)

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

  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).

  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.

  Day 0, Week 6, Week 12

Other Outcomes (3)

• Qualitative Feedback on Stimulation Timing

  Day 0, Week 6, Month 3

• Usability of the Cionic Neural Sleeve

  Week 12

• Impact of the Cionic Neural Sleeve

  Day 0, Week 6, Week 12

Study Arms (1)

Cionic Neural Sleeve NS-200

EXPERIMENTAL

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

Device: Cionic Neural Sleeve Multistim System

Interventions

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.

Cionic Neural Sleeve NS-200

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cionic, Inc.: lead

Study Sites (2)

Adapt Movement

Carlsbad, California, 92010, United States

RECRUITING

CIONIC

San Francisco, California, 94111, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Operations Manager

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 16, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)