Atlas Predicted DBS Settings in Essential Tremor

NCT ID: NCT02678429

Last Updated: 2023-03-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2021-11-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Programming Deep Brain Stimulation for the treatment of Essential Tremor can be a time intensive process. Using an atlas created using functional tremor responses in the operating room to determine the optimal settings would lead to a faster response for the patient and improved quality of life.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Essential Tremor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DBS programming, standard of care

DBS settings determined from the standard Neurologist symptomatic response first then change to settings from Atlas

Group Type ACTIVE_COMPARATOR

Change DBS programming

Intervention Type DEVICE

Patient will change their DBS settings to move from one DBS setting to the other, allowed one hour to adjust to the new setting prior to testing

DBS progamming from Atlas

DBS settings determined from the a functional atlas first then change to settings determined by standard of care

Group Type EXPERIMENTAL

Change DBS programming

Intervention Type DEVICE

Patient will change their DBS settings to move from one DBS setting to the other, allowed one hour to adjust to the new setting prior to testing

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Change DBS programming

Patient will change their DBS settings to move from one DBS setting to the other, allowed one hour to adjust to the new setting prior to testing

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Seleced for DBS of the VIM nucleus at Vanderbilt Medical center Diagnosis of essential tremor

Exclusion Criteria

Unable to use the patient handheld programmer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fenna Phibbs

Assistant Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

160155

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Connectomic Guided DBS for Parkinson's Disease
NCT06618157 ENROLLING_BY_INVITATION NA
Responsive Deep Brain Stimulator for Essential Tremor
NCT02649166 ACTIVE_NOT_RECRUITING NA