NCT01334814

Brief Summary

The proposed study is a randomized, single blind trial of intermittent versus continuous stimulation among essential tremor (ET) patients with a chronic history of continuous stimulation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2002

Longer than P75 for not_applicable

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

January 1, 2002

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2010

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

April 13, 2011

Completed
Last Updated

January 6, 2012

Status Verified

January 1, 2012

Enrollment Period

3.7 years

First QC Date

March 9, 2010

Last Update Submit

January 4, 2012

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (1)

  • sleep quality

    The trial is 10 weeks in length with clinical evaluations (about 60 minutes) performed on weeks 1, 2, 6, and 10, and phone interviews (about 5 minutes) on weeks 3, 4, 5, 7, 8, and 9.

    10 weeks

Secondary Outcomes (2)

  • measures of tremor,voltage threshold for optimal tremor control

    10 weeks

  • Side effects

    10 weeks

Interventions

Deep Brain Stimulation (Model 7438 Therapy Controller)DEVICE

Deep brain stimulation (DBS) is a surgical procedure used to treat a variety of disabling neurological symptoms

Also known as: Model 7438 Therapy Controller

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • individuals with essential tremor who are at least 6 months status-post thalamic stimulator placement
  • maintained a consistent chronic or intermittent stimulation schedule for at least 4 consecutive weeks prior to study enrollment
  • no changes in stimulation parameters for at least 2 consecutive months prior to study enrollment

You may not qualify if:

  • patients with clinically significant dementia (i.e., a score less than 24 out of 30 on the Mini Mental Status Exam14)
  • women who are not post-menopausal
  • patients with other significant neurological or psychiatric disease other than essential tremor
  • patients treated with pallidotomy or thalamotomy
  • patients with significant psychiatric disturbance as determined by Diagnostic and Statistical Manual-IV criteria which would make informed consent/cooperation problematic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Essential Tremor

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Ryan Uitti, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 9, 2010

First Posted

April 13, 2011

Study Start

January 1, 2002

Primary Completion

September 1, 2005

Study Completion

January 1, 2010

Last Updated

January 6, 2012

Record last verified: 2012-01