Neuropsychiatric Effects of Deep Brain Stimulation in Patients With Parkinson's Disease
1 other identifier
interventional
20
1 country
1
Brief Summary
Stimulation of the subthalamic nucleus will have effects on various aspects of neuropsychiatric function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 28, 2011
CompletedFirst Posted
Study publicly available on registry
March 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedAugust 2, 2019
July 1, 2019
6.4 years
February 28, 2011
July 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Deep Brain Stimulation
EXPERIMENTALParkinson's patients with deep brain stimulation in the subthalamic nucleus.
Interventions
Stimulation is delivered to the subthalamic nucleus at experimentally prescribed settings.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Scripps Clinic Torrey Pines
La Jolla, California, 92092, United States
Related 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(3):528-34. doi: 10.1016/j.neuropsychologia.2010.12.030. Epub 2010 Dec 22.
PMID: 21184765RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Aron, PhD
University of California, San Diego
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- DOUBLE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 28, 2011
First Posted
March 2, 2011
Study Start
July 1, 2008
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
August 2, 2019
Record last verified: 2019-07