Digital-HD

  • Research type

    Research Study

  • Full title

    Digital-HD: Studying digital biomarkers in Huntington's disease

  • IRAS ID

    242932

  • Contact name

    Edward Wild

  • Contact email

    e.wild@ucl.ac.uk

  • Sponsor organisation

    University College London

  • Clinicaltrials.gov Identifier

    Z6364106/2018/05/123, Sponsor data protection registration number

  • Duration of Study in the UK

    1 years, 4 months, 31 days

  • Research summary

    Huntington’s disease (HD) is an autosomal dominant genetic disease, which typically manifests beginning in adulthood in the form of movement symptoms, cognitive decline, and psychiatric changes. Currently the only approved treatment for HD is tetrabenazine, but several clinical trials are underway that explore novel therapeutic approaches to treating this disease. In preparation for such trials, biomarkers are needed to evaluate: (1) the effectiveness of these novel therapeutics at improving clinical signs and symptoms (efficacy biomarkers); and (2) the state of disease patients are in throughout the trial (disease progression biomarkers).

    Smartphones, wearables and other consumer technology have high quality sensors that enable the objective, remote, continuous, and longitudinal measurement of disease symptoms. Notable efforts to use such technologies in movement disorders have focused on Huntington’s Disease and Parkinson’s Disease. Markers for symptom severity and progression in such sensor data are known as “Digital Biomarkers.”

    Of the clinical progression measures for HD, several cognitive and motor measures that are sensitive to symptom progression lend themselves to sensor-based measurement. Fine motor impairments can be measured using touch sensors (e.g. circle tracing; speeded tapping7). Gait and balance have been successfully captured using wearable sensors), as have choreatic movement of HD patients.

    The objective is to further explore the feasibility of such an approach, the ability to separate HD patients from healthy controls, and the ability to correlate sensor-based measures with disease severity.

    The results of this study will set the ground work for the use of particular digital biomarkers in future clinical trials.

  • REC name

    London - Central Research Ethics Committee

  • REC reference

    18/LO/1986

  • Date of REC Opinion

    6 Nov 2018

  • REC opinion

    Further Information Favourable Opinion