Tracking Self-Reported Functional Needs and Quality of Life

December 15, 2025 updated by: Rebecca Webster, Cionic, Inc.

Tracking Reported Activities and Needs for Self-care, Function, Outcomes, Relief, and Mood

The study aims to characterize the population of Cionic Neural Sleeve users and assess their health-related quality of life.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

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
      • San Francisco, California, United States, 94111
        • CIONIC

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:

  • Resident of the United States
  • New customer awaiting the Cionic Neural Sleeve

Exclusion Criteria:

  • Implanted demand-type cardiac pacemaker or defibrillator
  • Malignant tumor or existing thrombosis in the impacted or more impacted leg
  • Fracture or dislocation in the impacted or more impacted 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: Treatment
  • 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 and receive stimulation assistance during the exercise and walking sessions.
Device: Cionic Neural Sleeve 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
Health Related Quality of Life
Time Frame: Day 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12
Health related quality of life will be assessed by the EuroQol-5 Dimensions 5-Levels (EQ-5D-5L), a 6-item instrument to describe health in 5 dimensions. Each response of the EQ-5D-5L is assigned a numerical value from 1 to 5, with 1 being "no problems" and 5 being "extreme problems".
Day 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spasticity
Time Frame: Day 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12
The impact of spasticity on walking or movement will be collected. The score ranges from 0 - 5, with a higher score reflecting more severe spasticity.
Day 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12
Urinary Incontinence
Time Frame: Day 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12
The frequency of urinary leaking will be collected. The score ranges from 1 - 5, with a higher score reflecting more frequent urinary incontinence.
Day 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12
Fatigue
Time Frame: Day 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12
The impact of fatigue will be collected. The score ranges from 1 - 5, with a higher score reflecting more severe fatigue.
Day 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12
Wear time
Time Frame: Every month from enrollment to the end of study at 12 months
Wear time measured by the usage log of the device, measured in hours.
Every month from enrollment to the end of study at 12 months
Device adherence
Time Frame: Every month from enrollment to the end of study at 12 months
Wear time measured by the usage log of the device, measured in step count.
Every month from enrollment to the end of study at 12 months

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 (Actual)

November 26, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

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 17, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIONIC-07-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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