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

Sponsor
BioSensics (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03599076
Collaborator
University of Rochester (Other)
50
Enrollment
1
Location
14.2
Anticipated Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: HD Wear

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Wearable Sensors for Quantitative Assessment of Motor Impairment in Huntington's Disease
Actual Study Start Date :
Sep 25, 2018
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Manifest HD

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

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

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

Outcome Measures

Primary Outcome Measures

  1. Chorea severity score [12 months]

    Remotely monitored chorea severity score based on movement data during activities of daily living

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • CAG expansion ≥ 36
Exclusion Criteria:
  • N/A

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Rochester Rochester New York United States 14642

Sponsors and Collaborators

  • BioSensics
  • University of Rochester

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
BioSensics
ClinicalTrials.gov Identifier:
NCT03599076
Other Study ID Numbers:
  • 1R44NS103648-01
First Posted:
Jul 26, 2018
Last Update Posted:
Jan 24, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Huntington Disease

Study Results

No Results Posted as of Jan 24, 2019