NCT00954772

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

December 2, 2011

Status Verified

August 1, 2009

Enrollment Period

5.9 years

First QC Date

August 5, 2009

Last Update Submit

November 30, 2011

Conditions

Movement Disorders

Keywords

Staged versus Simultaneous Bilateral DBS

Study Arms (2)

Staged Bilateral STN DBS

Simultaneous Bilateral STN DBS

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parkinson's patients who undergo STN DBS

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mt. Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Study Officials

  • Michael S Okun, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 7, 2009

Study Start

July 1, 2005

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

December 2, 2011

Record last verified: 2009-08

Locations

US(1)