NCT02443181

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

7 years

First QC Date

April 28, 2015

Last Update Submit

March 1, 2022

Conditions

Essential Tremor

Keywords

Essential tremor; closed-loop DBS

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events

    Adverse events will be tracked using CTCAE terminology.

    18 months

Secondary Outcomes (1)

  • Battery usage using demand-driven strategies for tremor control

    18 months

Study Arms (1)

Activa PC+S

EXPERIMENTAL

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.

Device: Activa PC+S

Interventions

Activa PC+SDEVICE

Implementation of closed loop DBS for essential tremor

Activa PC+S

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Appropriate candidates for DBS with essential tremor

You may not qualify if:

  • Prior trauma to the brain on side of putative implantation of stimulator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Department of Neurological Surgery

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Andrew Ko, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Neurological Surgery

Study Record Dates

First Submitted

April 28, 2015

First Posted

May 13, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

March 16, 2022

Record last verified: 2022-03

Locations

US(1)