Cionic Neural Sleeve for Parkinson's Disease (NCT07284823)

Overview

Overview

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["@nct"].

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["@nct"][@cionic].

Trial Details

| 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 |

Conditions Studied

• Parkinson's Disease (idiopathic)
• Gait impairment related to PD

Mechanism of Action

Functional Electrical Stimulation (FES)

The Cionic Neural Sleeve operates through functional electrical stimulation — a technique that uses electrical currents to activate specific muscles during movement. The mechanism involves:

• Hip flexion during swing phase
• Knee extension for stability
• Ankle dorsiflexion to clear the foot

How FES Differs from Other Approaches

| 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 |

Why Electrical Stimulation for PD

In Parkinson's disease, gait dysfunction results from:

• Dopaminergic neuron loss in the substantia nigra pars compacta
• Basal ganglia-thalamocortical circuit dysfunction affecting motor timing
• Reduced automaticity requiring conscious attention to maintain gait
• Muscle activation timing deficits during the gait cycle

The combination of movement-synchronized stimulation and wearable form factor makes this approach particularly suitable for real-world gait improvement during daily activities[@cionic].

Study Design

| 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 |

Study Phases

The trial follows a single-group design where all participants receive the Cionic Neural Sleeve intervention:

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

• Daily falls (frequent fallers)
• Cardiac pacemaker or other implanted electrical devices
• Leg tumors or history of leg thrombosis
• Recent bone fractures or joint dislocations
• Inability to comply with study procedures

Outcomes

Primary Outcomes

| 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 |

Secondary Outcomes

| 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 |

System Usability Scale (SUS)

The SUS is a widely-used questionnaire for evaluating perceived usability:

• Score Range: 0-100
• Interpretation:
• >80: Excellent usability
• 68-80: Good usability
• <68: Below average usability

Clinical Significance

Current Treatment Landscape for PD Gait

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 |

Potential Advantages of Cionic Neural Sleeve

Comparison with Similar Devices

| 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 |

Locations

Active Recruitment Sites

• Currently recruiting

• Currently recruiting

Future Directions

This safety and usability trial will pave the way for:

• Larger efficacy studies comparing FES to standard care
• Studies combining neural sleeve with other rehabilitation approaches
• Long-term follow-up to assess motor learning effects
• Home-use studies for continuous gait improvement

References