Mood and Subthalamic Nucleus (STN) Deep Brain Stimulation

NCT ID: NCT00954772

Last Updated: 2011-12-02

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

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2011-06-30

Brief Summary

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

The purpose of this research study is to investigate any changes seen in mood or behavior following deep brain stimulation for movement disorders.

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.

Movement Disorders

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Staged versus Simultaneous Bilateral DBS

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

Staged Bilateral STN DBS

No interventions assigned to this group

Simultaneous Bilateral STN DBS

No interventions assigned to this group

Eligibility Criteria

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

Inclusion Criteria

* Idiopathic PD diagnosed by a movement disorders neurologist
* Approved by a movement disorders neurologist as clinically needing a DBS device
* Absence of significant cognitive dysfunction (Mattis Dementia Rating Scale Score of greater than or equal to 116)
* MRI without evidence of structural abnormality (stroke, tumor, malformation, etc)
* No prior neurosurgical intervention

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

National Parkinson Foundation

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael S Okun, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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

Mt. Sinai School of Medicine

New York, New York, United States

Site Status

Countries

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

United States

Other Identifiers

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

00056229

Identifier Type: -

Identifier Source: org_study_id