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Completed

NCT Number: NCT02443181

Demand-driven Management of Essential Tremor

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.

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Key information

Conditions

Essential Tremor Central Nervous System Diseases Movement Disorders Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington Department of Neurological Surgery

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Activa PC+S

Device

Implementation of closed loop DBS for essential tremor

Primary outcomes

  1. Number of participants with adverse events

    Time frame: 18 months

    Adverse events will be tracked using CTCAE terminology.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

The Application of DBS Technologies for Demand-driven Management of Essential Tremor

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
May 13, 2015
Registry last updated
Mar 16, 2022

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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