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

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

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.

Study Overview

• Status: Unknown
• Conditions: Huntington Disease
• Intervention / Treatment: Other: HD Wear

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Joseph Gwin, PhD; Phone Number: 888-589-6213; Email: info@biosensics.com

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester
      • Contact: Jamie Adams, MD; Phone Number: 585-276-6825; Email: Jamie_Adams@urmc.rochester.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Huntington's Disease

Description

Inclusion Criteria:

• CAG expansion ≥ 36

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control	Other: HD Wear; Wearable sensor system for monitoring Huntington's chorea during activities of daily living
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chorea severity score	Remotely monitored chorea severity score based on movement data during activities of daily living	12 months

Collaborators and Investigators

• Sponsor: BioSensics
• Collaborators: University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: June 27, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 24, 2019
• Last Update Submitted That Met QC Criteria: January 22, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Dyskinesias; Heredodegenerative Disorders, Nervous System; Dementia; Cognition Disorders; Chorea; Huntington Disease
• Other Study ID Numbers: 1R44NS103648-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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