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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306539
• Other study ID #: HSC-07-4849
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Est. completion date: December 2014

Study information

• Verified date: July 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Procedure:
• Stimulation of the subthalamic nucleus
Stimulation is delivered to the subthalamic nucleus at experimentally prescribed settings.

Locations

Country	Name	City	State
United States	Scripps Clinic Torrey Pines	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

United States, 

References & Publications (1)

Greenhouse I, Gould S, Houser M, Hicks G, Gross J, Aron AR. Stimulation at dorsal and ventral electrode contacts targeted at the subthalamic nucleus has different effects on motor and emotion functions in Parkinson's disease. Neuropsychologia. 2011 Feb;49 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	behavioral task performance	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.	1 to 2 hours