Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-11

Study Completion Date

2025-04-02

Brief Summary

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

The objective of this study is to evaluate the performance of novel DBS programming methods compared to traditional programming methods.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease

NCT01839396

Parkinson's Disease

COMPLETED NA

Coordinated Reset Deep Brain Stimulation

NCT03732898

Parkinson's Disease (PD)

COMPLETED NA

Evaluation of Remote DBS Programming.

NCT05193825

Deep Brain Stimulation Telemedicine Parkinson Disease

COMPLETED NA

Circuit-Based Deep Brain Stimulation for Parkinson's Disease; Udall Project 1 Aim 2 and 3

NCT03079037

Parkinson Disease

COMPLETED

Deep Neural Network Approaches for Closed-Loop Deep Brain Stimulation

NCT04277689

Parkinson Disease

ENROLLING_BY_INVITATION NA

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.

Parkinson Disease

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.

Novel Arm

Programming completed by a novel method

Group Type ACTIVE_COMPARATOR

Vercise Deep Brain Stimulation System

Intervention Type DEVICE

Standard of Care Arm

Programming completed as Standard of care

Group Type OTHER

Vercise Deep Brain Stimulation System

Intervention Type DEVICE

Interventions

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

Vercise Deep Brain Stimulation System

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Implanted bilaterally in STN or GPi with a Vercise™ DBS system for Parkinson's disease, including directional leads, for at least four months and programming optimized according to standard of care with no changes to electrode configuration of primary settings for at least four weeks.
* Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
* Be at least 18 years of age.
* Device must have been implanted on label or must be on label by the time the subject gets enrolled.