Demand-driven Management of Essential Tremor

Essential Tremor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02443181
• Other study ID #: STUDY00001079
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: February 2022

Study information

• Verified date: March 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

Device:
• Activa PC+S
Implementation of closed loop DBS for essential tremor

Locations

Country	Name	City	State
United States	University of Washington Department of Neurological Surgery	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events	Adverse events will be tracked using CTCAE terminology.	18 months
Secondary	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.	18 months