Deep Brain Stimulation, Parkinson's Disease
Conditions
Keywords
PD, DBS
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.
Detailed description
In this study subjects undergo SPECT scans for CBF mapping. PD patients before the surgery and healthy controls undergo two scans. PD patients after the surgery undergo four scans. PD patients who undergo two scans before the surgery, undergo only two scans after the surgery. Uptake of Tc-ECD, a CBF radiotracer, is done in the following conditions: * For PD patients before the surgery - during the performance of the semantic verbal fluency task or at rest (total of 2 scans). * For PD patients after the surgery- during the performance of the semantic verbal fluency task or at rest, either at on-stimulation or off-stimulation condition (total of 4 scans). The stimulator is turned off by the neurologist for 10 min. * PD patients before and after the surgery- during performance of the semantic verbal fluency task or at rest before the surgery and during performance of the semantic verbal fluency task or at rest after the surgery only at off-stimulation condition (Total of 4 scans). * Healthy controls - during the performance of the semantic verbal fluency task or at rest (total of 2 scans). Following the Tc-ECD injection, the subjects are scanned by Irix SPECT camera for 15min. Scans are analyzed and the regional CBF is measured using imaging software. Statistical analysis is done to discover the effect of the surgery, stimulation and the disease on blood flow at rest and during task performance. In addition, differences between groups in number of words produced during the task are also statistically analyzed.
Interventions
RADIATIONInjection of 15mCi of Tc-ECD and scanning by SPECT camera
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.
BEHAVIORALSemantic verbal fluency task performance
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.
DEVICETurning off the stimulator
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.
Sponsors
Sheba Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Progressive idiopathic PD * For control group - age-matched to study groups
Exclusion criteria
* Progressive dementia or other psychiatric disorders * Other neurological conditions * Other physical disease * Intolerance of off stimulation state * Involuntary head motions * Hearing deficits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CBF values in different brain regions | 3 months to 2 years post-surgery |
Secondary
| Measure | Time frame |
|---|---|
| Number of words produced in the semantic fluency task | 3 months to 2 years post-surgery |
Countries
Israel
Contacts
Primary ContactSharon Hassin, MD
Backup ContactYafit Kuttner, B.Sc
Outcome results
None listed