NCT01978080

Brief Summary

The specific aim of this study is to evaluate if tremor severity and quality of life can be improved more using continuous home monitoring along with traditional assessments versus traditional assessments alone.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

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

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

December 10, 2014

Status Verified

December 1, 2014

Enrollment Period

1.2 years

First QC Date

October 31, 2013

Last Update Submit

December 9, 2014

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Impression-Change Scale score

    Utilized to measure any improvement or worsening of symptoms relative to a baseline state at enrollment

    End of Month 1, End of Month 2, End of Month 3

Secondary Outcomes (3)

  • Clinical Global Impression-Severity Scale Score

    Enrollment, End of Month 1, End of Month 2, End of Month 3

  • Washington Heights Inwood Genetic Study of Essential Tremor (WHIGET) Tremor Rating Scale

    Enrollment, End of Month 1, End of Month 2, End of Month 3

  • Quality of Life in Essential Tremor Questionnaire

    Enrollment, End of Month 1, End of Month 2, End of Month 3

Study Arms (2)

Tremor reports provided

EXPERIMENTAL

Kinesia HomeView utilized to monitor tremor at home and reports provided to treating clinician

Device: Kinesia HomeView

Tremor reports not provided

ACTIVE COMPARATOR

Kinesia HomeView utilized to monitor tremor at home and reports not provided to treating clinician

Device: Kinesia HomeView

Interventions

Kinesia HomeViewDEVICE
Tremor reports not providedTremor reports provided

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with essential tremor
  • Currently taking medication to control tremor

You may not qualify if:

  • Cognitive limitations that prevent comprehension or execution of study protocol

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 Tremor

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Dustin Heldman, PhD

    Great Lakes NeuroTechnologies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 7, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Last Updated

December 10, 2014

Record last verified: 2014-12

Locations

US(2)