Parkinson Disease (PD)NCT07284823
Safety and Usability of the Cionic Neural Sleeve for Parkinson's Disease
A study testing Cionic Neural Sleeve Multistim System in people with Parkinson Disease (PD), run by Cionic, Inc. at 2 sites in United States.
Trial summary
This research will investigate the safety and usability of the Cionic Neural Sleeve Multistim System for Parkinson's Disease. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Parkinson Disease (PD)
- What is being tested?
- Cionic Neural Sleeve Multistim System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2025to Dec 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported gait impairment
- Have access to a smartphone with iOS or Android operating system with Bluetooth capabilities and internet connection
- Ability to walk with or without an assistive device for up to 1 minute
- Leg measurements within sizing range of the Cionic Neural Sleeve
Who cannot join
- Daily occurrence of falls
- Implanted demand-type cardiac pacemaker or defibrillator
- Malignant tumor or existing thrombosis in the leg
- Fracture or dislocation in the leg that could be adversely affected by motion from stimulation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Adapt Movement
Carlsbad, California, 92010
Adam Heredia, EdD, 675-321-8846, adam@cionic.com
- Recruiting
CIONIC
San Francisco, California, 94111
Rebecca Webster, PhD, 925-788-6649, rebecca@cionic.com
About this study
This research will investigate the safety and usability of the Cionic Neural Sleeve Multistim System for Parkinson's Disease.
- Conditions
- Parkinson Disease (PD)
- Being tested
- Cionic Neural Sleeve Multistim System
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cionic Neural Sleeve Multistim 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 during the study and receive stimulation assistance during walking. Receives: Device: Cionic Neural Sleeve Multistim System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Able to Independently Exit a Stimulation Program Using the Cionic Neural Sleeve
Participants' ability to independently exit (terminate) an active stimulation program on the Cionic Neural Sleeve will be assessed during study visits. Independence is defined as successful completion of the task without verbal cueing or physical assistance from study staff. Study staff will document whether the participant is able to exit the program independently (yes/no) at each visit.
Measured: Day 0, Week 6, Week 12
Number of Participants Able to Independently Test Stimulation Using the Cionic Neural Sleeve
Participants' ability to independently initiate and test stimulation on the Cionic Neural Sleeve will be assessed during study visits. Successful task completion is defined as the participant correctly activating stimulation and confirming perception of stimulation without assistance. Study staff will document successful independent testing (yes/no).
Measured: Day 0, Week 6, Week 12
Number of Participants Able to Independently Calibrate the Cionic Neural Sleeve System
Participants' ability to independently complete device calibration of the Cionic Neural Sleeve system will be assessed during study visits. Calibration is defined as completion of the device-guided calibration procedure without verbal or physical assistance. Study staff will document successful independent calibration (yes/no).
Measured: Day 0, Week 6, Week 12
Safety of the Cionic Neural Sleeve
To understand the device's safety profile and potential side effects, researchers will record any adverse events during their home use.
Measured: Day 0, Week 6, Week 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 startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT07284823
- Sponsor's protocol ID
- CIONIC-08-001
- Status last verified
- Nov 2025
- First submitted
- 9 Dec 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Usability of the Cionic Neural Sleeve for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07284823
- Acronym / sponsor ID
- CIONIC-08-001
- Conditions
- Parkinson Disease (PD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cionic, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (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.
This research will investigate the safety and usability of the Cionic Neural Sleeve Multistim System for Parkinson's Disease.
Study design
- Primary purpose
- Other
- 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 Multistim SystemParticipants will wear the device during the study and receive stimulation assistance during walking. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-reported gait impairment
- Have access to a smartphone with iOS or Android operating system with Bluetooth capabilities and internet connection
- Ability to walk with or without an assistive device for up to 1 minute
- Leg measurements within sizing range of the Cionic Neural Sleeve
Key exclusion criteria (4 listed)
- Daily occurrence of falls
- Implanted demand-type cardiac pacemaker or defibrillator
- Malignant tumor or existing thrombosis in the leg
- Fracture or dislocation in the 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 Multistim 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
Number of Participants Able to Independently Exit a Stimulation Program Using the Cionic Neural Sleeve
Time frame: Day 0, Week 6, Week 12
Participants' ability to independently exit (terminate) an active stimulation program on the Cionic Neural Sleeve will be assessed during study visits. Independence is defined as successful completion of the task without verbal cueing or physical assistance from study staff. Study staff will document whether the participant is able to exit the program independently (yes/no) at each visit.
Number of Participants Able to Independently Test Stimulation Using the Cionic Neural Sleeve
Time frame: Day 0, Week 6, Week 12
Participants' ability to independently initiate and test stimulation on the Cionic Neural Sleeve will be assessed during study visits. Successful task completion is defined as the participant correctly activating stimulation and confirming perception of stimulation without assistance. Study staff will document successful independent testing (yes/no).
Number of Participants Able to Independently Calibrate the Cionic Neural Sleeve System
Time frame: Day 0, Week 6, Week 12
Participants' ability to independently complete device calibration of the Cionic Neural Sleeve system will be assessed during study visits. Calibration is defined as completion of the device-guided calibration procedure without verbal or physical assistance. Study staff will document successful independent calibration (yes/no).
Safety of the Cionic Neural Sleeve
Time frame: Day 0, Week 6, Week 12
To understand the device's safety profile and potential side effects, researchers will record any adverse events during their home use.
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 18 Dec 2025.
- Individual participant dataSharing planned: No
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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.
2 sites 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 Multistim System in people with Parkinson Disease (PD), run by Cionic, Inc. at 2 sites 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 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 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Able to Independently Exit a Stimulation Program Using the Cionic Neural Sleeve (time frame: Day 0, Week 6, Week 12). The study lists 4 primary outcomes in all. 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 18 Dec 2025.