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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 : Not yet recruiting
First Posted : July 25, 2018
Last Update Posted : July 25, 2018
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
BioSensics

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
Huntington Disease Other: HD Wear

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Wearable Sensors for Quantitative Assessment of Motor Impairment in Huntington's Disease
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Chorea severity score [ Time Frame: 12 months ]
    Remotely monitored chorea severity score based on movement data during activities of daily living



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Huntington's Disease
Criteria

Inclusion Criteria:

  • CAG expansion ≥ 36

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599076


Contacts
Contact: Joseph Gwin, PhD 888-589-6213 info@biosensics.com

Sponsors and Collaborators
BioSensics
University of Rochester

Responsible Party: BioSensics
ClinicalTrials.gov Identifier: NCT03599076     History of Changes
Other Study ID Numbers: 1R44NS103648-01 ( U.S. NIH Grant/Contract )
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
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
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders