NCT02443181

Demand-driven Management of Essential Tremor

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DEVICE	Activa PC+S	Implementation of closed loop DBS for essential tremor

Timeline

• Start date: 2015-02-01
• Primary completion: 2022-02-01
• Completion: 2022-02-01
• First posted: 2015-05-13
• Last updated: 2022-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study