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CUE1 Device for Parkinson's Disease (NCT06174948)
CUE1 Non-Invasive Vibrotactile Device for Parkinson's Disease (NCT06174948)
Overview
The CUE1 device is a non-invasive sensory stimulation device developed by [Queen Mary University of London](https://www.qmul.ac.uk/) that delivers vibrotactile cueing to improve motor function in patients with Parkinson's disease and related disorders. The device targets freezing of gait and other motor symptoms through unilateral vibrational cueing, providing external sensory feedback to help initiate and maintain movement["@nct"].
CUE1 Non-Invasive Vibrotactile Device for Parkinson's Disease (NCT06174948)
Overview
The CUE1 device is a non-invasive sensory stimulation device developed by [Queen Mary University of London](https://www.qmul.ac.uk/) that delivers vibrotactile cueing to improve motor function in patients with Parkinson's disease and related disorders. The device targets freezing of gait and other motor symptoms through unilateral vibrational cueing, providing external sensory feedback to help initiate and maintain movement["@nct"].
This feasibility study (NCT06174948) investigates whether the CUE1 device can reduce freezing of gait, improve walking automaticity, and enhance quality of life in patients with idiopathic Parkinson's disease and various related movement disorders["@nct"].
Trial Details
| Parameter | Value |
|-----------|-------|
| NCT Number | NCT06174948 |
| Title | The Use of the CUE1/CUE1+ Device in People With Idiopathic Parkinson's Disease and Related Disorders: A Feasibility Study |
| Status | Recruiting |
| Phase | Not Applicable (Feasibility Study) |
| Sponsor | Queen Mary University of London |
| Principal Investigator | Cristina Simonet, PhD |
| Intervention | CUE1 non-invasive vibrotactile stimulation device |
| Enrollment | 70 participants (estimated) |
| Start Date | March 25, 2024 |
| Estimated Primary Completion | March 31, 2025 |
| Location | London, United Kingdom |
Conditions Studied
The trial includes patients with:
- Idiopathic Parkinson's disease
- Progressive supranuclear palsy (PSP)
- Multiple system atrophy (MSA)
- Corticobasal degeneration/syndrome (CBD/CBS)
- Vascular Parkinsonism
- Orthostatic tremor
- Dystonia
- Essential tremor
Mechanism of Action
Vibrotactile Cueing Fundamentals
The CUE1 device operates on the principle of sensory cueing, a well-established rehabilitation strategy for Parkinson's disease gait dysfunction. The mechanism involves:
Why Sensory Cueing Works in PD
In Parkinson's disease, gait dysfunction stems from:
- Dopaminergic neuron loss in the substantia nigra pars compacta
- Basal ganglia circuitry disruption affecting motor initiation and execution
- Reduced walking automaticity requiring conscious attention to gait
- Freezing of gait episodes where patients feel their feet are "glued" to the floor
The CUE1 device provides an alternative sensory pathway to initiate and maintain movement. Unlike auditory cues (which can be distracting or unavailable in noisy environments) or visual cues (which require constant attention), vibrotactile cues can be delivered continuously without requiring conscious attention or visual focus.
CUE1 vs. CUE1+
The study evaluates two versions of the device:
- CUE1 — Standard vibrotactile cueing device
- CUE1+ — Enhanced version with additional features
Study Design
Trial Phases
The feasibility study consists of two sequential phases:
Phase 1: Initial Safety and Feasibility
- Design: Single-group open-label study
- Participants: 10 patients with Parkinson's disease + 10-20 patients with related disorders
- Purpose: Assess safety, tolerability, and preliminary efficacy
Phase 2: Randomized Controlled Trial
- Design: Double-blind, sham-controlled randomized trial
- Participants: 30-40 new Parkinson's disease patients
- Allocation: Active CUE1+ vs. sham (silent device settings)
- Purpose: Evaluate efficacy compared to placebo
| Element | Details |
|---------|---------|
| Study Type | Interventional |
| Allocation | Randomized (Phase 2) |
| Intervention Model | Parallel |
| Masking | Double-blind (Phase 2) |
| Purpose | Feasibility/Efficacy |
Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
- Severe cognitive impairment preventing device use
- Active neurological conditions other than target disorder
- Skin conditions affecting sensory perception at stimulation site
- Inability to comply with study procedures
Outcomes
Primary Outcomes (Feasibility Measures)
| Outcome | Description |
|---------|-------------|
| Recruitment Rate | Number of participants enrolled per month |
| Compliance | Adherence to prescribed device usage schedule |
| Dropout Rate | Participant retention through study completion |
| Safety/Tolerability | Physical observation for adverse events |
Secondary Outcomes (Clinical Efficacy)
| Outcome | Assessment Tool |
|---------|-----------------|
| Motor Function | MDS-UPDRS Part III (Motor Examination) |
| Gait & Balance | Timed Up and Go (TUG) test |
| Gait Stability | Functional Gait Assessment |
| Quality of Life | Parkinson's Disease Questionnaire-39 (PDQ-39) |
| Fatigue | Fatigue Severity Scale |
| Sleep Quality | Pittsburgh Sleep Quality Index |
Clinical Significance
Current Treatment Gap
Current Parkinson's disease therapies address:
- Dopamine replacement (levodopa, dopamine agonists) — primarily for resting tremor and bradykinesia
- Deep brain stimulation — for advanced cases with motor fluctuations
- Physical therapy — gait training and balance exercises
However, freezing of gait and movement initiation difficulties often remain refractory to these treatments, significantly impacting quality of life and increasing fall risk.
Potential Benefits of CUE1 Device
Comparison with Other Non-invasive Approaches
| Modality | Mechanism | Application |
|----------|-----------|-------------|
| CUE1 (Vibrotactile) | Tactile sensory cueing | Wearable, continuous |
| Auditory cueing | Rhythmic sound cues | Requires speaker/headphones |
| Visual cueing | Laser beam or patterned floor | Fixed environment |
| tDCS | Electrical brain modulation | Session-based |
| rTMS | Magnetic brain stimulation | Clinic-based |
- [Parkinson's Disease](/genes/ar)
- Freezing of Gait
- [Basal Ganglia](/brain-regions/basal-ganglia)
- [Substantia Nigra](/brain-regions/substantia-nigra)
- [Dopamine](/proteins/d1-dopamine-receptor)
- [Gait Dysfunction in Parkinson's Disease](/genes/ar)
- Non-Invasive Brain Stimulation
- [Physical Therapy for Parkinson's Disease](/genes/ar)
- [Parkinson's Disease Treatment Overview](/companies/overview)
- [Clinical Trials in Parkinson's Disease](/genes/ar)
- [Alzheimer's Disease](/diseases/alzheimers-disease)
- [Parkinson's Disease](/genes/ar)
External Links
- [PubMed](https://pubmed.ncbi.nlm.nih.gov/)
- [KEGG Pathways](https://www.genome.jp/kegg/pathway.html)
Contact Information
- Principal Investigator: Cristina Simonet, PhD
- Email: c.simonet@qmul.ac.uk
- Institution: Queen Mary University of London, United Kingdom
- Trial Registration: [ClinicalTrials.gov NCT06174948](https://clinicaltrials.gov/study/NCT06174948)
References
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