Overview
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clinical_trials_cionic_neural_["Cionic Neural Sleeve for Parkinsons Disease NC"]
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clinical_trials_cion_0["Trial Details"]
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clinical_trials_cion_1["Conditions Studied"]
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clinical_trials_cion_2["Mechanism of Action"]
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clinical_trials_cion_3["Functional Electrical Stimulation FES"]
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clinical_trials_cion_4["How FES Differs from Other Approaches"]
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clinical_trials_cion_5["Why Electrical Stimulation for PD"]
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...Overview
Mermaid diagram (expand to render)
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:
Movement Detection — Sensors in the sleeve detect the user's movement phase (swing vs. stance)
Targeted Stimulation — Electrical pulses are delivered to specific muscle groups at precise moments during the gait cycle
Muscle Activation — Stimulation induces muscle contractions that assist with:
- Hip flexion during swing phase
- Knee extension for stability
- Ankle dorsiflexion to clear the foot
4.
Motor Learning — Repeated use may promote neuroplasticity and long-term motor recovery
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
FES addresses these deficits by:
Providing external muscle activation that compensates for impaired central drive
Timing stimulation to coincide with the appropriate phase of the gait cycle
Enhancing proprioceptive feedback from muscle spindles
Enabling functional movement even when internal motor commands are disruptedThe 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:
Baseline Assessment — Pre-intervention evaluation of gait function
Device Fitting — Proper sizing and positioning of the neural sleeve
Calibration — Device programming for individual participant needs
Intervention Period — Use of device during daily activities and supervised sessions
Follow-up Assessment — Post-intervention evaluationsEligibility Criteria
Inclusion Criteria
Age 22-75 years
Clinical diagnosis of Parkinson's disease
Self-reported gait impairment
Access to smartphone with Bluetooth capability
Ability to walk for at least 1 minute continuously
Leg measurements within sizing range for the deviceExclusion 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
A score of 68+ is typically considered the threshold for acceptable usability[@sus].
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
Direct Muscle Activation — Unlike sensory cueing, FES directly assists movement
Movement-Synchronized — Stimulation timing adapts to the gait cycle
Wearable — Can be used during daily activities, not just in clinic
Non-Pharmacological — No drug interactions or systemic side effects
Complementary — Can be used alongside standard PD medications
Rehabilitation Potential — May promote long-term motor recovery through neuroplasticityComparison 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
Carlsbad, California
San Francisco, California
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
[NCT07284823 - Safety and Usability of the Cionic Neural Sleeve for Parkinson's Disease](https://clinicaltrials.gov/study/NCT07284823)
[Cionic, Inc. - Neural Sleeve Technology](https://www.cionic.com/)
[Timed Up and Go Test - Standardized Assessment Protocol](https://pubmed.ncbi.nlm.nih.gov/8815059/)
[System Usability Scale (SUS) - Brooke (1996)](https://doi.org/10.1007/BF00148113)
[Movement Disorder Society - UPDRS](https://www.movementdisorders.org/MDS.htm)