CUE1 Non-Invasive Vibrotactile Device for Parkinson's Disease

CUE1 Non-Invasive Vibrotactile Device for Parkinson's Disease

Overview

CUE1 Non-Invasive Vibrotactile Device for Parkinson's Disease

Overview

<table class="infobox infobox-therapeutic">
<tr>
<th class="infobox-header" colspan="2">CUE1 Non-Invasive Vibrotactile Device for Parkinson's Disease</th>
</tr>
<tr>
<td class="label">Parameter</td>
<td>Value</td>
</tr>
<tr>
<td class="label">NCT Number</td>
<td>NCT06174948</td>
</tr>
<tr>
<td class="label">Title</td>
<td>The Use of the CUE1/CUE1+ Device in People With Idiopathic [Parkinson's Disease](/diseases/parkinsons-disease) and Related Disorders: A Feasibility Study</td>
</tr>
<tr>
<td class="label">Status</td>
<td>Recruiting</td>
</tr>
<tr>
<td class="label">Phase</td>
<td>Not Applicable (Feasibility Study)</td>
</tr>
<tr>
<td class="label">Sponsor</td>
<td>Queen Mary University of London</td>
</tr>
<tr>
<td class="label">Principal Investigator</td>
<td>Cristina Simonet, PhD</td>
</tr>
<tr>
<td class="label">Intervention</td>
<td>CUE1 non-invasive vibrotactile stimulation device</td>
</tr>
<tr>
<td class="label">Enrollment</td>
<td>70 participants (estimated)</td>
</tr>
<tr>
<td class="label">Start Date</td>
<td>March 25, 2024</td>
</tr>
<tr>
<td class="label">Estimated Primary Completion</td>
<td>March 31, 2025</td>
</tr>
<tr>
<td class="label">Location</td>
<td>London, United Kingdom</td>
</tr>
<tr>
<td class="label">Element</td>
<td>Details</td>
</tr>
<tr>
<td class="label">Study Type</td>
<td>Interventional</td>
</tr>
<tr>
<td class="label">Allocation</td>
<td>Randomized (Phase 2)</td>
</tr>
<tr>
<td class="label">Intervention Model</td>
<td>Parallel</td>
</tr>
<tr>
<td class="label">Masking</td>
<td>Double-blind (Phase 2)</td>
</tr>
<tr>
<td class="label">Purpose</td>
<td>Feasibility/Efficacy</td>
</tr>
<tr>
<td class="label">Outcome</td>
<td>Description</td>
</tr>
<tr>
<td class="label">Recruitment Rate</td>
<td>Number of participants enrolled per month</td>
</tr>
<tr>
<td class="label">Compliance</td>
<td>Adherence to prescribed device usage schedule</td>
</tr>
<tr>
<td class="label">Dropout Rate</td>
<td>Participant retention through study completion</td>
</tr>
<tr>
<td class="label">Safety/Tolerability</td>
<td>Physical observation for adverse events</td>
</tr>
<tr>
<td class="label">Outcome</td>
<td>Assessment Tool</td>
</tr>
<tr>
<td class="label">Motor Function</td>
<td>MDS-UPDRS Part III (Motor Examination)</td>
</tr>
<tr>
<td class="label">Gait & Balance</td>
<td>Timed Up and Go (TUG) test</td>
</tr>
<tr>
<td class="label">Gait Stability</td>
<td>Functional Gait Assessment</td>
</tr>
<tr>
<td class="label">Quality of Life</td>
<td>Parkinson's Disease Questionnaire-39 (PDQ-39)</td>
</tr>
<tr>
<td class="label">Fatigue</td>
<td>Fatigue Severity Scale</td>
</tr>
<tr>
<td class="label">Sleep Quality</td>
<td>Pittsburgh Sleep Quality Index</td>
</tr>
<tr>
<td class="label">Modality</td>
<td>Mechanism</td>
</tr>
<tr>
<td class="label">CUE1 (Vibrotactile)</td>
<td>Tactile sensory cueing</td>
</tr>
<tr>
<td class="label">Auditory cueing</td>
<td>Rhythmic sound cues</td>
</tr>
<tr>
<td class="label">Visual cueing</td>
<td>Laser beam or patterned floor</td>
</tr>
<tr>
<td class="label">tDCS</td>
<td>Electrical brain modulation</td>
</tr>
<tr>
<td class="label">rTMS</td>
<td>Magnetic brain stimulation</td>
</tr>
</table>

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](/diseases/parkinsons-disease) and related disorders. The device targets [freezing of gait](/symptoms/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](/diseases/parkinsons-disease) and various related movement disorders["@nct"].

Trial Details

Conditions Studied

The trial includes patients with:

• Idiopathic [Parkinson's disease](/diseases/parkinsons-disease)
• [Progressive supranuclear palsy](/diseases/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](/diseases/parkinsons-disease) gait dysfunction. The mechanism involves:

Why Sensory Cueing Works in PD

In [Parkinson's disease](/diseases/parkinsons-disease), gait dysfunction stems from:

• Dopaminergic neuron loss in the [substantia nigra pars compacta](/brain-regions/substantia-nigra)
• 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

CUE1 vs. CUE1+

The study evaluates two versions of the device:

• CUE1 — Standard vibrotactile cueing device
• CUE1+ — Enhanced version with additional features (specific enhancements not detailed in available protocols)

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](/diseases/parkinsons-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](/diseases/parkinsons-disease) patients
• Allocation: Active CUE1+ vs. sham (silent device settings)
• Purpose: Evaluate efficacy compared to placebo

Design Elements

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

(Detailed exclusion criteria not fully specified in available protocol; standard neurological trial exclusions typically include)

• 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)

Secondary Outcomes (Clinical Efficacy)

Assessment Schedule

• Baseline assessment prior to device use
• Regular intervals during treatment period
• Follow-up assessment post-treatment

Clinical Significance

Current Treatment Gap

Current [Parkinson's disease](/diseases/parkinsons-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

Potential Benefits of CUE1 Device

Comparison with Other Non-invasive Approaches

Related Pages

• [Parkinson's Disease](/diseases/parkinsons-disease)
• [Freezing of Gait](/symptoms/freezing-of-gait)
• [Basal Ganglia](/brain-regions/basal-ganglia)
• [Substantia Nigra](/brain-regions/substantia-nigra)
• [Dopamine](/entities/dopamine)
• [Gait Dysfunction in Parkinson's Disease](/mechanisms/parkinson-gait-dysfunction)
• [Non-Invasive Brain Stimulation](/mechanisms/non-invasive-brain-stimulation)
• [Physical Therapy for Parkinson's Disease](/therapeutics/physical-therapy)
• [Parkinson's Disease Treatment Overview](/therapeutics/parkinson-treatment)
• [Clinical Trials in Parkinson's Disease](/clinical-trials/parkinsons-disease)

See Also

• [Parkinson's disease](/diseases/parkinsons-disease)
• [Progressive supranuclear palsy](/diseases/progressive-supranuclear-palsy)
• [Parkinson's Disease](/diseases/parkinsons-disease)
• [Gait Dysfunction in Parkinson's Disease](/mechanisms/parkinson-gait-dysfunction)
• [Non-Invasive Brain Stimulation](/mechanisms/non-invasive-brain-stimulation)
• [Physical Therapy for Parkinson's Disease](/therapeutics/physical-therapy)
• [Parkinson's Disease Treatment Overview](/therapeutics/parkinson-treatment)

External Links

• [PubMed](https://pubmed.ncbi.nlm.nih.gov/)
• [KEGG Pathways](https://www.genome.jp/kegg/pathway.html)

Allen Brain Atlas Resources

• [Allen Brain Atlas - Gene Expression](https://human.brain-map.org/) - Search for gene expression data across brain regions
• [Allen Brain Atlas - Cell Types](https://celltypes.brain-map.org/) - Explore neuronal cell type taxonomy

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

Related Hypotheses

From the [SciDEX Exchange](/exchange) — scored by multi-agent debate

• [PARP1 Inhibition Therapy](/hypothesis/h-69919c49) — <span style="color:#81c784;font-weight:600">0.67</span> · Target: PARP1
• [Arginine Methylation Enhancement Therapy](/hypothesis/h-19003961) — <span style="color:#81c784;font-weight:600">0.65</span> · Target: PRMT1

Pathway Diagram

The following diagram shows the key molecular relationships involving CUE1 Non-Invasive Vibrotactile Device for Parkinson's Disease discovered through SciDEX knowledge graph analysis: