Mapping Mood in the Subthalamic Nucleus in Parkinson's Disease (PD)

NCT ID: NCT00847431

Last Updated: 2016-05-04

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

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2015-12-31

Brief Summary

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

The goal of this study is to determine the vulnerability of mood-related neurocircuitry in Parkinson Disease (PD) using deep brain stimulation of the subthalamic nucleus (STN DBS).

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's Disease Depression Anxiety

Study Design

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

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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

STN DBS Group

PD patients with deep brain stimulators in the subthalamic nucleus. Subjects within this group will be placed into either a 1 contact group, or 2 contact group, depending on contact location requirements for this study.

No interventions assigned to this group

Control Group

PD patients without deep brain stimulator surgery, with similar symptoms to the study group.

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

* Age 40 or older
* DBS STN Surgery in past 2 to 36 months
* Ability to tolerate turning off Stimulators
* Ability to read and comprehend questions
* English speaking


* Age 40 or older
* Ability to read and comprehend questions
* English speaking

Exclusion Criteria

* Other severe complications post surgery: stroke, seizure, major loss of consciousness, other brain trauma/surgery, or head injuries(i.e. near drowning), encephalitis, or hydrocephalus, blindness, deafness
* Clinically determined Dementia ( Most recent MMSE score of \>24)


* Other severe complications post surgery: stroke, seizure, major loss of consciousness, other brain trauma/surgery, or head injuries(i.e. near drowning), encephalitis, or hydrocephalus, blindness, deafness
* Clinically determined Dementia ( Most recent MMSE score of \>24)
* Plans to have DBS STN surgery in the next 24 months
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Washington University School of Medicine

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.

Tamara G Hershey, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

University of Cincinnati, Movement Disorder Center

Cincinnati, Ohio, 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.

R01NS058797-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

08-0354

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Deep Brain Stimulation and Parkinson's Disease
NCT02795663 COMPLETED EARLY_PHASE1