Tracking Self-Reported Functional Needs and Quality of Life

NCT ID: NCT07284810

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-26

Study Completion Date

2027-03-31

Brief Summary

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

Detailed Description

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Conditions

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Upper Motor Neuron Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cionic Neural Sleeve NS-200

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

Group Type EXPERIMENTAL

Cionic Neural Sleeve System

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cionic, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Rebecca Webster

Clinical Operations Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CIONIC

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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CIONIC-07-001

Identifier Type: -

Identifier Source: org_study_id