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

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ClinicalTrials.gov Identifier: NCT03599076
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : January 24, 2019
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
BioSensics

Tracking Information
First Submitted Date June 27, 2018
First Posted Date July 25, 2018
Last Update Posted Date January 24, 2019
Actual Study Start Date September 25, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 23, 2018)
Chorea severity score [ Time Frame: 12 months ]
Remotely monitored chorea severity score based on movement data during activities of daily living
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03599076 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Wearable Sensors for Quantitative Assessment of Motor Impairment in Huntington's Disease Huntington's Disease
Official Title Wearable Sensors for Quantitative Assessment of Motor Impairment in Huntington's Disease
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Huntington's Disease
Condition Huntington Disease
Intervention Other: HD Wear
Wearable sensor system for monitoring Huntington's chorea during activities of daily living
Study Groups/Cohorts
  • Manifest HD
    Intervention: Other: HD Wear
  • Premanifest HD
    Intervention: Other: HD Wear
  • Control
    Intervention: Other: HD Wear
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 23, 2018)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • CAG expansion ≥ 36

Exclusion Criteria:

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Joseph Gwin, PhD 888-589-6213 info@biosensics.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03599076
Other Study ID Numbers 1R44NS103648-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party BioSensics
Study Sponsor BioSensics
Collaborators University of Rochester
Investigators Not Provided
PRS Account BioSensics
Verification Date January 2019