Upper Motor Neuron DiseaseNCT07284810
Tracking Self-Reported Functional Needs and Quality of Life
A study testing Cionic Neural Sleeve System in people with Upper Motor Neuron Disease, run by Cionic, Inc. at 1 site in United States.
Trial summary
The study aims to characterize the population of Cionic Neural Sleeve users and assess their health-related quality of life. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Upper Motor Neuron Disease
- What is being tested?
- Cionic Neural Sleeve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resident of the United States
- New customer awaiting the Cionic Neural Sleeve
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Upper Motor Neuron Disease
- Being tested
- Cionic Neural Sleeve System
- Medical subject headings
- Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Cionic Neural Sleeve NS-200 | Experimental | Participants will wear the device and receive stimulation assistance during the exercise and walking sessions. Receives: Device: Cionic Neural Sleeve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Day 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start26 Nov 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Motor Neuron DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cionic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Rebecca Webster, Cionic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284810
- Sponsor's protocol ID
- CIONIC-07-001
- Status last verified
- Mar 2025
- First submitted
- 9 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking Reported Activities and Needs for Self-care, Function, Outcomes, Relief, and Mood
- ClinicalTrials.gov ID
- NCT07284810
- Acronym / sponsor ID
- CIONIC-07-001
- Conditions
- Upper Motor Neuron Disease
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Cionic, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to characterize the population of Cionic Neural Sleeve users and assess their health-related quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cionic Neural Sleeve NS-200 | Experimental | Device: Cionic Neural Sleeve SystemParticipants will wear the device and receive stimulation assistance during the exercise and walking sessions. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Resident of the United States
- New customer awaiting the Cionic Neural Sleeve
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cionic Neural Sleeve SystemThe sleeve assists participants during physical activity by delivering electrical stimulation that helps contract the necessary muscles at the correct time to improve movement. | Device | Cionic Neural Sleeve NS-200 |
Primary outcome
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".
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cionic Neural Sleeve System in people with Upper Motor Neuron Disease, run by Cionic, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Related Quality of Life (time frame: Day 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.