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Enrolling by Invitation

NCT Number: NCT07284810

Tracking Self-Reported Functional Needs and Quality of Life

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

Enrolling by Invitation

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Key information

Conditions

Upper Motor Neuron Disease Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CIONIC

San Francisco, California, 94111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cionic Neural Sleeve 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.

Primary outcomes

  1. 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".

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Cionic, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 16, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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