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

NCT ID: NCT03599076

Last Updated: 2019-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-25

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Huntington Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Manifest HD

HD Wear

Intervention Type OTHER

Wearable sensor system for monitoring Huntington's chorea during activities of daily living

Premanifest HD

HD Wear

Intervention Type OTHER

Wearable sensor system for monitoring Huntington's chorea during activities of daily living

Control

HD Wear

Intervention Type OTHER

Wearable sensor system for monitoring Huntington's chorea during activities of daily living

Interventions

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HD Wear

Wearable sensor system for monitoring Huntington's chorea during activities of daily living

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* CAG expansion ≥ 36

Exclusion Criteria

* N/A
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Rochester

OTHER

Sponsor Role collaborator

BioSensics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Rochester

Rochester, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Joseph Gwin, PhD

Role: CONTACT

888-589-6213

Facility Contacts

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Jamie Adams, MD

Role: primary

585-276-6825

Other Identifiers

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1R44NS103648-01

Identifier Type: NIH

Identifier Source: org_study_id

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