Neuropsychiatric Effects of Deep Brain Stimulation in Patients With Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Procedure: Stimulation of the subthalamic nucleus

• Registration Number: NCT01306539
• Lead Sponsor: University of California, San Diego

Brief Summary

Stimulation of the subthalamic nucleus will have effects on various aspects of neuropsychiatric function.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2011-02-28
• Study First Submitted QC: 2011-03-01
• Study First Posted: 2011-03-02
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-31
• Last Update Posted: 2019-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Participants diagnosed with idiopathic Parkinson's disease that meet criteria for treatment of their disease with STN-DBS. Participants will be selected for this study without regard for age (provided they are older than 18), gender or ethnic background.
• Participants must have undergone subthalamic nucleus DBS surgery and be receiving treatment at the Scripps Clinic in La Jolla, CA

Exclusion Criteria

• Patients under 18 years old.
• Patients with mini-mental status scores below 26/30.
• Patients with known psychiatric disease.
• Patients who are too infirm, demented or dysarthric to clearly understand the consenting process, task instructions, or to communicate verbally regarding participation or non-participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Deep Brain Stimulation	Stimulation of the subthalamic nucleus	Parkinson's patients with deep brain stimulation in the subthalamic nucleus.

Primary Outcome Measures

Name	Time	Method
behavioral task performance	1 to 2 hours	Participants will complete behavioral tasks at each of three visits to assess the effects of stimulation settings on task performance. At each research visit, behavior will be assessed beginning at 1 hour after the stimulation is adjusted to the experimental settings. Stimulation settings will be returned to each patient's treatment levels at the culmination of each visit.

Trial Locations

Locations (1)

Scripps Clinic Torrey Pines; 🇺🇸 La Jolla, California, United States