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)

Not Applicable

• Conditions: Parkinson's Disease; Deep Brain Stimulation
• Interventions: Radiation: Injection of 15mCi of Tc-ECD and scanning by SPECT camera; Behavioral: Semantic verbal fluency task performance; Device: Turning off the stimulator

• Registration Number: NCT01037686
• Lead Sponsor: Sheba Medical Center

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.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2009-09-29
• Status Verified: 2009-12
• Study First Submitted QC: 2009-12-22
• Last Update Submitted: 2009-12-22
• Study First Posted: 2009-12-23
• Last Update Posted: 2009-12-23
• Primary Completion: 2010-04
• Study Completion: 2010-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PD, DBS, healthy controls	Semantic verbal fluency task performance	Patients with idiopathic PD before or after DBS surgery (during on or off-stimulation) and healthy controls.
PD, DBS, healthy controls	Turning off the stimulator	Patients with idiopathic PD before or after DBS surgery (during on or off-stimulation) and healthy controls.
PD, DBS, healthy controls	Injection of 15mCi of Tc-ECD and scanning by SPECT camera	Patients with idiopathic PD before or after DBS surgery (during on or off-stimulation) and healthy controls.

Primary Outcome Measures

Name	Time	Method
CBF values in different brain regions	3 months to 2 years post-surgery

Secondary Outcome Measures

Name	Time	Method
Number of words produced in the semantic fluency task	3 months to 2 years post-surgery

Trial Locations

Locations (1)

Movement Disorders Clinic, Sheba Medical Center; 🇮🇱 Ramat Gan, Israel