The Effect of Electrode Implantation for Deep Brain Stimulation (DBS) on Brain Function Using Single Photon Emission Computed Tomography (SPECT) With Technetium-99m-ethyl Cysteinatedimer (Tc-ECD)
Exploring the Effect of Electrode Implantation for DBS on Brain Function During Rest and During Semantic Verbal Fluency Task Using SPECT With Tc-ECD
1 other identifier
interventional
120
1 country
1
Brief Summary
The goal of this study is to explore the effect of subthalamic nucleus (STN)-DBS surgery and stimulation in PD (Parkinson's disease) patients on regional cerebral blood (CBF) flow during cognitive task performance or at rest.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2006
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 29, 2009
CompletedFirst Posted
Study publicly available on registry
December 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedDecember 23, 2009
December 1, 2009
4.2 years
September 29, 2009
December 22, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CBF values in different brain regions
3 months to 2 years post-surgery
Secondary Outcomes (1)
Number of words produced in the semantic fluency task
3 months to 2 years post-surgery
Study Arms (1)
PD, DBS, healthy controls
OTHERPatients with idiopathic PD before or after DBS surgery (during on or off-stimulation) and healthy controls.
Interventions
All subjects (PD patients with or without DBS and healthy controls) will be injected with 15mCi of Tc-ECD and afterwards will be scanned by an Irix SPECT camera.
All Subjects (PD patients with or without DBS and healthy controls) before one of the two scans will perform the semantic verbal fluency task during the Tc-ECD uptake for 9 minutes. Before the other scan subjects will be at rest.
For PD patients treated with DBS, the neurologist will turn off the stimulator after the injection of Tc-ECD for ten minutes and then turn it back on.
Eligibility Criteria
You may qualify if:
- Progressive idiopathic PD
- For control group - age-matched to study groups
You may not qualify if:
- Progressive dementia or other psychiatric disorders
- Other neurological conditions
- Other physical disease
- Intolerance of "off stimulation" state
- Involuntary head motions
- Hearing deficits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Movement Disorders Clinic, Sheba Medical Center
Ramat Gan, 52621, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
September 29, 2009
First Posted
December 23, 2009
Study Start
February 1, 2006
Primary Completion
April 1, 2010
Study Completion
October 1, 2010
Last Updated
December 23, 2009
Record last verified: 2009-12