Recruiting NCT07284823
Safety and Usability of the Cionic Neural Sleeve for Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cionic Neural Sleeve Multistim System.
- Who it may be relevant to
- Registry conditions: Parkinson Disease (PD). Basic parameters: 22 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This research will investigate the safety and usability of the Cionic Neural Sleeve Multistim System for Parkinson's Disease.
Interventions
- 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.
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 2 centers
- Adapt Movement — Carlsbad
- CIONIC — San Francisco
Identifiers
NCT: NCT07284823 · CIONIC-08-001