Wearable Sensors for Quantitative Assessment of Motor Imp... | NCT03599076

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

NCT03599076

Sponsor

BioSensics

Status

Unknown status

Last Update Posted

Jan 24, 2019Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Huntington Disease

Interventions

HD Wear

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 25, 2018Actual

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Jun 27, 2018

First Submission Date that Met QC Criteria

Jul 23, 2018

First Posted Date

Jul 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2019

Last Update Posted Date

Jan 24, 2019Actual

Name	Class
University of Rochester	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Manifest HD			Other: HD Wear
Premanifest HD			Other: HD Wear
Control			Other: HD Wear

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HD Wear	Other	Wearable sensor system for monitoring Huntington's chorea during activities of daily living	Control Manifest HD Premanifest HD

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CAG expansion ≥ 36

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Huntington's Disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joseph Gwin, PhD	Contact	888-589-6213		info@biosensics.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Rochester	Recruiting	Rochester	New York	14642	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006816	Huntington Disease

Ancestor Terms

ID	Term
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided