The Use of the CUE1/CUE1+ in People With Parkinson's Disease and Related Disorders

NARecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

March 25, 2024

Primary Completion Date

March 31, 2025

Study Completion Date

March 31, 2025

Conditions
Parkinson's Disease and ParkinsonismProgressive Supranuclear PalsyDifferent Types of Tremor Including Essential TremorDystoniaMultiple System AtrophyCorticobasal DegenerationVascular ParkinsonismOrthostatic Tremor
Interventions
DEVICE

CUE1 non-invasive device

This is a 9-week feasibility study which will involve wearing the CUE1 device on a daily basis at participants' homes while they continue their usual activities of daily living (ADL). The CUE1 is a non-invasive medical device which delivers low frequency metronomes like tactile cueing and high frequency focused vibrotactile stimulation. All participants will be using the same pre-programmed settings for the CUE1 device which are: vibration strength delivered at 80%, pulse length 800 milliseconds (ms), and rest length 800ms as set at baseline and will not change. The CUE1 device is attached to the skin via an adhesive patch which has been dermatologically tested and approved. Participants will be provided with the adhesive patches and shown how to use them and the CUE1 device by the research team.

DEVICE

CUE1+ device active vs sham CUE1+ device

30-40 participants with idiopathic Parkinson's disease only will be randomly allocated to one of two interventions groups: one group will use the active CUE1+ device while the other group will use the CUE1+ at silent settings (e.g., sham device). All participants will use their device in the same way which is starting the usage from the morning, within an hour once they took their medications for Parkinson's (if any) and continue using the device for 8 hours, once a day, every day for 12 weeks

Trial Locations (1)

EC1M 6BQ

RECRUITING

Queen Mary University of London, London

All Listed Sponsors
collaborator

Barts & The London NHS Trust

OTHER

collaborator

Homerton University Hospital

UNKNOWN

lead

Queen Mary University of London

OTHER