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Trial record 1 of 121 for:    "Benign essential tremor syndrome"
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Demand-driven Management of Essential Tremor

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ClinicalTrials.gov Identifier: NCT02443181
Recruitment Status : Recruiting
First Posted : May 13, 2015
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew Ko, University of Washington

Brief Summary:
This study evaluates the effectiveness of tremor control using various strategies for implementing demand-driven thalamic deep brain stimulation (DBS) for essential tremor. Therapeutic stimulation at the Vim nucleus of the thalamus will be initiated and modulated using signals derived from external sensors (e.g. EMG, accelerometer) and cortical or thalamic electrodes.

Condition or disease Intervention/treatment Phase
Essential Tremor Device: Activa PC+S Not Applicable

Detailed Description:

Essential tremor is effectively treated with deep brain stimulation of the ventralis intermedius nucleus of the thalamus, presumably because high-frequency stimulation disrupts aberrant cerebellar-thalamic input. For the most part, patients with essential tremor have a kinetic tremor that is present or worsened with movement. However, DBS therapy is currently continuous, and thus, stimulation occurs when the patient will not benefit symptomatically from treatment. This exposes the patient to unnecessary stimulation, which can lead to unnecessary usage of battery, unnecessary exposure to stimulation side-effects, and can possibly contribute to tolerance to DBS therapy.

One possible solution is selective stimulation when movement is required. This study will determine signals predictive of motor activity using external sensors such as EMG, and cortical biomarkers of real and imaginary movement that are well-characterized.

The primary aim is to demonstrate successful initiation and modulation of DBS therapy using the Activa PC+S system and implanted cortical or thalamic electrodes. Putative improvements in battery usage related to stimulation on-time and definition of coupling signals between thalamus and cortex that characterize tremor state are secondary outcomes.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Application of DBS Technologies for Demand-driven Management of Essential Tremor
Study Start Date : February 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
Experimental: Activa PC+S
Patients will be implanted with standard DBS electrodes for treatment of essential tremor, at the Vim nucleus of the thalamus, and an additional subdural electrode array overlying hand motor cortex.. The patient will receive standard of care programming for thalamic stimulation for essential tremor. During research study visits, implementation and evaluation of closed-loop DBS using the PC+S system will be performed.
Device: Activa PC+S
Implementation of closed loop DBS for essential tremor




Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 18 months ]
    Adverse events will be tracked using CTCAE terminology.


Secondary Outcome Measures :
  1. Battery usage using demand-driven strategies for tremor control [ Time Frame: 18 months ]
    Battery usage will be measured as stimulation on-time and voltage over time using demand-driven stimulation paradigms versus continuous stimulation paradigm.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Appropriate candidates for DBS with essential tremor

Exclusion Criteria:

  • Not meeting inclusion criteria based on tremor amplitude, neuropsychological testing, etc.
  • Prior trauma to the brain on side of putative implantation of stimulator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443181


Contacts
Contact: Andrew Ko, MD 206-543-3570 alko00@u.washington.edu
Contact: Jeff Ojemann, MD 206-543-3570 jojemann@u.washington.edu

Locations
United States, Washington
University of Washington Department of Neurological Surgery Recruiting
Seattle, Washington, United States, 98195
Contact: Andrew Ko, MD    206-543-3570    alko00@u.washington.edu   
Contact: Jeff Ojemann, MD    206-543-3570    jojemann@u.washington.edu   
Principal Investigator: Andrew L Ko, MD         
Principal Investigator: Jeff G Ojemann, MD         
Principal Investigator: Howard Chizeck, PhD         
Principal Investigator: Jeff Herron, PhD         
Sub-Investigator: Maggie Thompson, BS         
Sub-Investigator: Brady Houston, BS         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Andrew Ko, MD University of Washington

Responsible Party: Andrew Ko, Assistant Professor, Department of Neurological Surgery, University of Washington
ClinicalTrials.gov Identifier: NCT02443181     History of Changes
Other Study ID Numbers: STUDY00001079
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018

Keywords provided by Andrew Ko, University of Washington:
Essential tremor; closed-loop DBS

Additional relevant MeSH terms:
Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases