The Cionic Neural Sleeve Multistim System is a wearable electrical stimulation device designed to improve motor function in patients with Parkinson's disease. Unlike dopamine replacement therapies that work systemically, this device provides targeted neuromuscular electrical stimulation during movement to enhance gait stability, reduce freezing of gait, and improve overall mobility[1].
This clinical trial (NCT07284823) investigates the safety and usability of the Cionic Neural Sleeve in individuals with Parkinson's disease who experience gait impairment. The device represents a novel approach to PD rehabilitation by combining functional electrical stimulation (FES) with real-time movement detection[1:1][2].
| Parameter | Value |
|---|---|
| NCT Number | NCT07284823 |
| Title | Safety and Usability of the Cionic Neural Sleeve Multistim System for Parkinson's Disease |
| Status | RECRUITING |
| Phase | Not Applicable (Device Safety/Usability Study) |
| Sponsor | Cionic, Inc. |
| Intervention | Cionic Neural Sleeve Multistim System (Device) |
| Enrollment | Not specified (estimated 20-40 participants) |
| Start Date | December 2025 |
| Primary Completion | December 2026 |
| Locations | Carlsbad, CA; San Francisco, CA |
The Cionic Neural Sleeve operates through functional electrical stimulation — a technique that uses electrical currents to activate specific muscles during movement. The mechanism involves:
| Modality | Target | Mechanism |
|---|---|---|
| Cionic Neural Sleeve (FES) | Peripheral nerves/muscles | Direct muscle activation during movement |
| Deep Brain Stimulation | Central nervous system (subthalamic nucleus, globus pallidus) | High-frequency electrical modulation of brain circuits |
| tDCS | Cerebral cortex | Non-invasive transcranial direct current stimulation |
| Vibrotactile (CUE1) | Sensory system | Somatosensory cueing to bypass basal ganglia |
In Parkinson's disease, gait dysfunction results from:
FES addresses these deficits by:
The combination of movement-synchronized stimulation and wearable form factor makes this approach particularly suitable for real-world gait improvement during daily activities[2:1].
| Element | Details |
|---|---|
| Study Type | Interventional |
| Allocation | Single-group (all participants receive device) |
| Intervention Model | Single arm |
| Masking | Open-label (no blinding) |
| Purpose | Safety and Usability |
The trial follows a single-group design where all participants receive the Cionic Neural Sleeve intervention:
| Outcome | Description |
|---|---|
| Independence in Exiting Stimulation Program | Participant's ability to start/stop the device without assistance |
| Testing Stimulation | Participant's ability to verify device functionality |
| Calibrating Device | Participant's ability to adjust device settings |
| Safety/Adverse Events | Frequency and severity of device-related adverse events |
| Outcome | Assessment Method |
|---|---|
| Qualitative Feedback on Timing | User interviews on stimulation timing during gait |
| System Usability Scale (SUS) | Standardized usability questionnaire (score 0-100) |
| Timed Up and Go (TUG) Test | Standardized gait and mobility assessment |
The SUS is a widely-used questionnaire for evaluating perceived usability:
80: Excellent usability
A score of 68+ is typically considered the threshold for acceptable usability[3].
Existing PD treatments address different aspects of the disease:
| Treatment | Primary Target | Gait Effect |
|---|---|---|
| Levodopa | Dopamine replacement | Improves bradykinesia; less effective for gait freezing |
| DBS | Brain circuits | Improves overall motor function; variable gait effects |
| Physical Therapy | Rehabilitation | Effective but requires intensive training |
| CUE1 (Vibrotactile) | Sensory cueing | Improves freezing; requires attention to cue |
| Device | Company | Mechanism | Status |
|---|---|---|---|
| Cionic Neural Sleeve | Cionic, Inc. | FES during gait | NCT07284823 (Recruiting) |
| CUE1 | Queen Mary Univ. | Vibrotactile cueing | NCT06174948 (Recruiting) |
| CHARCO Array | Charco Neurotech | Vibrotactile stimulation | Research phase |
| Bioness L300 Go | Bioness | FES for foot drop | FDA cleared |
Carlsbad, California
San Francisco, California
This safety and usability trial will pave the way for: