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Demand-driven Management of Essential Tremor

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ClinicalTrials.gov Identifier: NCT02443181
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : March 16, 2022
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
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
Actual Primary Completion Date : February 2022
Actual Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

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.

Information from the National Library of Medicine

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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

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

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United States, Washington
University of Washington Department of Neurological Surgery
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
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Principal Investigator: Andrew Ko, MD University of Washington
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Responsible Party: Andrew Ko, Assistant Professor, Department of Neurological Surgery, University of Washington
ClinicalTrials.gov Identifier: NCT02443181    
Other Study ID Numbers: STUDY00001079
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: March 16, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Andrew Ko, University of Washington:
Essential tremor; closed-loop DBS
Additional relevant MeSH terms:
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Essential Tremor
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases