Health TrialsbyHealthPanel

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

ConditionParkinson Disease (PD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-75
SponsorCionic, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Cionic Neural Sleeve NS-200Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 0, Week 6, Week 12
2

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).

Time frame
Day 0, Week 6, Week 12
3

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).

Time frame
Day 0, Week 6, Week 12
4

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.

Time frame
Day 0, Week 6, Week 12

Secondary outcomes

Other outcomes

1

Qualitative Feedback on Stimulation Timing

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.

Time frame
Day 0, Week 6, Month 3
2

Usability of the Cionic Neural Sleeve

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.

Time frame
Week 12
3

Impact of the Cionic Neural Sleeve

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.

Time frame
Day 0, Week 6, Week 12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cionic, Inc.

Lead sponsor

Source ClinicalTrials.gov
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