Demand-driven Management of Essential Tremor

Not Applicable

Completed

• Conditions: Essential Tremor
• Interventions: Device: Activa PC+S

• Registration Number: NCT02443181
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-04-28
• Study First Submitted QC: 2015-05-09
• Study First Posted: 2015-05-13
• Primary Completion: 2022-02
• Study Completion: 2022-02
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Activa PC+S	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	18 months	Adverse events will be tracked using CTCAE terminology.

Secondary Outcome Measures

Name	Time	Method
Battery usage using demand-driven strategies for tremor control	18 months	Battery usage will be measured as stimulation on-time and voltage over time using demand-driven stimulation paradigms versus continuous stimulation paradigm.

Trial Locations

Locations (1)

University of Washington Department of Neurological Surgery; 🇺🇸 Seattle, Washington, United States