Recruiting

Cionic Neural Sleeve

Sponsor:

Cionic, Inc.

Code:

NCT07284823

Conditions

Parkinson Disease (PD)

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

Cionic Neural Sleeve Multistim System

Study Details

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)

Study ID

NCT07284823

Start date

Dec, 2025

Status verified date

Nov, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Cionic Neural Sleeve NS-200

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

Interventions

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.

Primary outcome measure

  • Number of Participants Able to Independently Exit a Stimulation Program Using the Cionic Neural Sleeve [ Time Frame: 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 ]
  • Number of Participants Able to Independently Calibrate the Cionic Neural Sleeve System [ Time Frame: Day 0, Week 6, Week 12 ]
  • Safety of the Cionic Neural Sleeve [ Time Frame: Day 0, Week 6, Week 12 ]

Central Contacts and Locations

Locations

Adapt Movement

Recruiting

Carlsbad, California, United States, 92010

Contacts

Adam Heredia, EdD

675-321-8846adam@cionic.com

CIONIC

Recruiting

San Francisco, California, United States, 94111

Contacts

Rebecca Webster, PhD

925-788-6649rebecca@cionic.com

More Information

Sponsor

Cionic, Inc.

Last update posted

Dec 18, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cionic, Inc. on 2025-12-18.