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Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01334814
First Posted: April 13, 2011
Last Update Posted: January 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mayo Clinic
March 9, 2010
April 13, 2011
January 6, 2012
January 2002
September 2005   (Final data collection date for primary outcome measure)
sleep quality [ Time Frame: 10 weeks ]
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.
Same as current
Complete list of historical versions of study NCT01334814 on ClinicalTrials.gov Archive Site
  • measures of tremor,voltage threshold for optimal tremor control [ Time Frame: 10 weeks ]
  • Side effects [ Time Frame: 10 weeks ]
Same as current
Not Provided
Not Provided
 
Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor
Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor
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.
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. 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. The study includes outcome measures of tremor, stimulation-induced side effects, sleep quality, and voltage threshold for optimal tremor control and sustained side-effects.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Essential Tremor
Device: Deep Brain Stimulation (Model 7438 Therapy Controller)
Deep brain stimulation (DBS) is a surgical procedure used to treat a variety of disabling neurological symptoms
Other Name: Model 7438 Therapy Controller
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
January 2010
September 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
50 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01334814
1324-02
No
Not Provided
Not Provided
Ryan J. Uitti, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Ryan Uitti, MD Mayo Clinic
Mayo Clinic
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP