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NCT03599076 Clinical Trial

Wearable Sensors for Quantitative Assessment of Motor Impairment in Huntington's Disease Huntington's Disease

Huntington Disease Clinical Trial

Official title:
Wearable Sensors for Quantitative Assessment of Motor Impairment in Huntington's Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03599076
Other study ID # 1R44NS103648-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 25, 2018
Est. completion date December 2019

Study information
Verified date January 2019
Source BioSensics
Contact Joseph Gwin, PhD
Phone 888-589-6213
Email info@biosensics.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The principal means of measuring motor impairment in Huntington disease (HD) is the Unified Huntington's Disease Rating Scale (UHDRS) total motor score, which is subjective, categorical, requires significant training to administer correctly, and only captures impairments in clinic. In this Direct to Phase II SBIR we will develop a wearable sensor system for objective, sensitive, and continuous assessment of Huntington's chorea during activities of daily living. The developed technology could be used clinically to detect changes in motor function in response to medications, or could be used scientifically to expedite and reduce the cost of early stage pharmaceutical clinical trials.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- CAG expansion = 36

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• HD Wear
Wearable sensor system for monitoring Huntington's chorea during activities of daily living

Locations
Country Name City State
United States University of Rochester Rochester New York

Sponsors (2)
Lead Sponsor Collaborator
BioSensics University of Rochester

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Chorea severity score Remotely monitored chorea severity score based on movement data during activities of daily living 12 months
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