The CUE1 device is a non-invasive sensory stimulation device developed by Queen Mary University of London 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[1].
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[1:1].
| 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 |
The trial includes patients with:
The CUE1 device operates on the principle of sensory cueing, a well-established rehabilitation strategy for Parkinson's disease gait dysfunction. The mechanism involves:
In Parkinson's disease, gait dysfunction stems from:
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.
The study evaluates two versions of the device:
The feasibility study consists of two sequential phases:
| Element | Details |
|---|---|
| Study Type | Interventional |
| Allocation | Randomized (Phase 2) |
| Intervention Model | Parallel |
| Masking | Double-blind (Phase 2) |
| Purpose | Feasibility/Efficacy |
| 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 |
| 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 |
Current Parkinson's disease therapies address:
However, freezing of gait and movement initiation difficulties often remain refractory to these treatments, significantly impacting quality of life and increasing fall risk.
| 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 |
Freezing of Gait
Non-Invasive Brain Stimulation