Demand-driven Management of Essential Tremor
Primary Purpose
Essential Tremor
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Activa PC+S
Sponsored by
About this trial
This is an interventional basic science trial for Essential Tremor focused on measuring Essential tremor; closed-loop DBS
Eligibility 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
Sites / Locations
- University of Washington Department of Neurological Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Activa PC+S
Arm 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.
Outcomes
Primary Outcome Measures
Number of participants with adverse events
Adverse events will be tracked using CTCAE terminology.
Secondary Outcome Measures
Battery usage using demand-driven strategies for tremor control
Battery usage will be measured as stimulation on-time and voltage over time using demand-driven stimulation paradigms versus continuous stimulation paradigm.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02443181
Brief Title
Demand-driven Management of Essential Tremor
Official Title
The Application of DBS Technologies for Demand-driven Management of Essential Tremor
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2022 (Actual)
Study Completion Date
February 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
Essential tremor; closed-loop DBS
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Activa PC+S
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Activa PC+S
Intervention Description
Implementation of closed loop DBS for essential tremor
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Description
Adverse events will be tracked using CTCAE terminology.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Battery usage using demand-driven strategies for tremor control
Description
Battery usage will be measured as stimulation on-time and voltage over time using demand-driven stimulation paradigms versus continuous stimulation paradigm.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Ko, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Department of Neurological Surgery
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Demand-driven Management of Essential Tremor
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