Adaptive Portable Essential Tremor Monitor | NCT01602042

Studies
Adaptive Portable Essential Tremor Monitor

NCT01602042

Sponsor

Great Lakes NeuroTechnologies Inc.

Status

Completed

Last Update Posted

Dec 4, 2012Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Essential Tremor

Interventions

Not provided

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

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

May 16, 2012

First Submission Date that Met QC Criteria

May 17, 2012

First Posted Date

May 18, 2012Estimated

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

Dec 3, 2012

Last Update Posted Date

Dec 4, 2012Estimated

Name	Class
Rush University Medical Center	OTHER
Baylor College of Medicine	OTHER
National Institute on Aging (NIA)	NIH

Description Module

Brief Summary

The purpose of this study is to evaluate the utility of a portable motion sensor-based system designed to monitor essential tremor (ET) to better prescribe therapy to minimize symptoms and expand care for ET patients.

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

Not provided

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

20Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tremor ratings during activities of daily living versus standardized tasks.		10 hours each day the sensor is worn.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18 years or older
Clinical diagnosis of essential tremor
Able to provide informed consent

Exclusion Criteria:

Significant medical or psychiatric illness
Not capable of following the required clinical instructions
Serious medical conditions that compromise safety

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Essential tremor

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dustin A Heldman, PhD	CleveMed Inc. also dba Great Lakes NeuroTechnologies	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rush University Medical Center		Chicago	Illinois	60612	United States
Baylor College of Medicine

Condition Browse Module

MeSH Terms

ID	Term
D020329	Essential Tremor
D014202	Tremor

Ancestor Terms

ID	Term
D009069	Movement Disorders
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020820	Dyskinesias

Browse Leaves

Not provided

Browse Branches

Not provided