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Completed

NCT Number: NCT01334814

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Model 7438 Therapy Controller

Primary outcomes

  1. 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.

Secondary outcomes

  1. measures of tremor,voltage threshold for optimal tremor control

    Time frame: 10 weeks

  2. Side effects

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2002
Primary completion
2005
Study completion
2010
First posted
Apr 13, 2011
Registry last updated
Jan 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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