NCT01602042

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2012

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

December 4, 2012

Status Verified

December 1, 2012

Enrollment Period

6 months

First QC Date

May 16, 2012

Last Update Submit

December 3, 2012

Conditions

Essential Tremor

Keywords

essential tremormotion sensorstremor

Outcome Measures

Primary Outcomes (1)

  • Tremor ratings during activities of daily living versus standardized tasks.

    10 hours each day the sensor is worn.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Essential tremor

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Essential TremorTremor

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dustin A Heldman, PhD

    CleveMed Inc. also dba Great Lakes NeuroTechnologies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2012

First Posted

May 18, 2012

Study Start

May 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

December 4, 2012

Record last verified: 2012-12

Locations

US(2)