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)

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01037686
• Other study ID #: SHEBA-05-3972-SH-CTIL
• Status: Recruiting
• Phase: N/A
• First received: September 29, 2009
• Last updated: December 22, 2009
• Start date: February 2006
• Est. completion date: October 2010

Study information

• Verified date: December 2009
• Source: Sheba Medical Center
• Contact: Sharon Hassin, MD
• Phone: 97235305791
• Email: sharon.hassin[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Parkinson Disease
• Parkinson's Disease

Intervention

Radiation:
• Injection 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.

Behavioral:
• Semantic 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.

Device:
• Turning 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.

Locations

Country	Name	City	State
Israel	Movement Disorders Clinic, Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CBF values in different brain regions		3 months to 2 years post-surgery	No
Secondary	Number of words produced in the semantic fluency task		3 months to 2 years post-surgery	No