Skip to main content
Clinical Trials/NCT01037686
NCT01037686
Unknown
Not Applicable

Exploring the Effect of Electrode Implantation for DBS on Brain Function During Rest and During Semantic Verbal Fluency Task Using SPECT With Tc-ECD

Sheba Medical Center1 site in 1 country120 target enrollmentFebruary 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
Sheba Medical Center
Enrollment
120
Locations
1
Primary Endpoint
CBF values in different brain regions
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2006
End Date
October 2010
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

CBF values in different brain regions

Time Frame: 3 months to 2 years post-surgery

Secondary Outcomes

  • Number of words produced in the semantic fluency task(3 months to 2 years post-surgery)

Study Sites (1)

Loading locations...

Similar Trials