NCT07284810

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Nov 2025Mar 2027

Study Start

First participant enrolled

November 26, 2025

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

December 17, 2025

Status Verified

March 1, 2025

Enrollment Period

1.3 years

First QC Date

December 9, 2025

Last Update Submit

December 15, 2025

Conditions

Upper Motor Neuron Disease

Outcome Measures

Primary Outcomes (1)

  • Health Related Quality of Life

    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 Outcomes (5)

  • Wear time

    Every month from enrollment to the end of study at 12 months

  • Device adherence

    Every month from enrollment to the end of study at 12 months

  • Spasticity

    Day 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12

  • +2 more other outcomes

Study Arms (1)

Cionic Neural Sleeve NS-200

EXPERIMENTAL

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

Device: Cionic Neural Sleeve System

Interventions

Cionic Neural Sleeve SystemDEVICE

The sleeve assists participants during physical activity by delivering electrical stimulation that helps contract the necessary muscles at the correct time to improve movement.

Cionic Neural Sleeve NS-200

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIONIC

San Francisco, California, 94111, United States

Location

MeSH Terms

Conditions

Motor Neuron Disease

Condition Hierarchy (Ancestors)

Neurodegenerative DiseasesNervous System DiseasesNeuromuscular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Operations Manager

Study Record Dates

First Submitted

December 9, 2025

First Posted

December 16, 2025

Study Start

November 26, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

December 17, 2025

Record last verified: 2025-03

Locations

US(1)