Demand-driven Management of Essential Tremor
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02443181|
Recruitment Status : Recruiting
First Posted : May 13, 2015
Last Update Posted : May 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Essential Tremor||Device: Activa PC+S||Not Applicable|
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|
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
- Number of participants with adverse events [ Time Frame: 18 months ]Adverse events will be tracked using CTCAE terminology.
- 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.
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
|Contact: Andrew Ko, MDfirstname.lastname@example.org|
|Contact: Jeff Ojemann, MDemail@example.com|
|United States, Washington|
|University of Washington Department of Neurological Surgery||Recruiting|
|Seattle, Washington, United States, 98195|
|Contact: Andrew Ko, MD 206-543-3570 firstname.lastname@example.org|
|Contact: Jeff Ojemann, MD 206-543-3570 email@example.com|
|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|
|Principal Investigator:||Andrew Ko, MD||University of Washington|