Seattle, Washington 98195


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

STUDY00001079


NCT ID:

NCT02443181


Secondary ID:


Study Acronym:


Brief Title:

Demand-driven Management of Essential Tremor


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Washington


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

10


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Andrew Ko, MD
Principal Investigator
University of Washington
Primary Contact:Andrew Ko, MD
206-543-3570
alko00@u.washington.edu
Backup Contact:Jeff Ojemann, MD
206-543-3570
jojemann@u.washington.edu

Study Dates

Start Date:February 2015
Completion Date:February 2020
Completion Type:Anticipated
Primary Completion Date:February 2020
Primary Completion Type:Anticipated
Verification Date:May 2018
Last Changed Date:May 10, 2018
First Received Date:April 28, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Battery usage using demand-driven strategies for tremor control
Time Frame:18 months
Safety Issues:False
Description:Battery usage will be measured as stimulation on-time and voltage over time using demand-driven stimulation paradigms versus continuous stimulation paradigm.
Outcome Type:Primary Outcome
Measure:Number of participants with adverse events
Time Frame:18 months
Safety Issues:False
Description:Adverse events will be tracked using CTCAE terminology.

Study Interventions

Intervention Type:Device
Name:Activa PC+S
Description:Implementation of closed loop DBS for essential tremor
Arm Name:Activa PC+S

Study Arms

Study Arm Type:Experimental
Arm Name:Activa PC+S
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Washington

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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