Mood and Subthalamic Nucleus (STN) Deep Brain Stimulation | NCT00954772

Studies
Mood and Subthalamic Nucleus (STN) Deep Brain Stimulation

NCT00954772

Sponsor

University of Florida

Status

Completed

Last Update Posted

Dec 2, 2011Estimated

Enrollment

91Actual

Phase

Not provided

Conditions

Movement Disorders

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Aug 5, 2009

First Submission Date that Met QC Criteria

Aug 6, 2009

First Posted Date

Aug 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2011

Last Update Posted Date

Dec 2, 2011Estimated

Name	Class
National Parkinson Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

91Actual

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Parkinson's patients who undergo STN DBS

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael S Okun, MD	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mt. Sinai School of Medicine		New York	New York	10029	United States

Condition Browse Module

MeSH Terms

ID	Term
D009069	Movement Disorders

Ancestor Terms

ID	Term
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Staged Bilateral STN DBS
Simultaneous Bilateral STN DBS