CUE1 Non-Invasive Vibrotactile Device for Parkinson's Disease
Overview
Mermaid diagram (expand to render)
<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:
External Sensory Feedback — The device delivers subtle vibrational stimuli to a specific body location (typically the wrist or torso)
Movement Initiation — The tactile cue provides an external reference point that helps bypass the dysfunctional basal ganglia circuitry
Rhythmic Guidance — Consistent vibrotactile patterns can help regulate stride length and cadence
Attentional Focus — The conscious perception of the cue draws attention to movement, partially compensating for automaticity deficitsWhy 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
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 (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
Clinical diagnosis of idiopathic [Parkinson's disease](/diseases/parkinsons-disease) or related disorder
Age 18 years or older
Capable of providing informed consent
Willingness to use device as directedExclusion 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
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
Non-invasive — No surgical implantation required
Continuous use — Can be worn during daily activities
Complementary — Works alongside standard dopaminergic medications
Cost-effective — Lower resource requirements than surgical options
Minimal side effects — Vibrotactile stimulation has excellent tolerabilityComparison 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
- 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
Unknown, NCT06174948 - CUE1/CUE1+ Device Feasibility Study (n.d.)
Unknown, Queen Mary University of London - CUE1 Device Research (n.d.)
Unknown, MDS-UPDRS - Movement Disorder Society Unified Parkinson's Disease Rating Scale (n.d.)
Unknown, Parkinson's Disease Questionnaire-39 (PDQ-39) (n.d.)
[Unknown, Freezing of Gait in Parkinson's Disease - Movement Disorders (n.d.)](https://doi.org/10.1002/mds.28211)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:
Mermaid diagram (expand to render)