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)

Sponsor

Sheba Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01037686

Collaborator

(none)

120

Enrollment

Location

Arm

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease Deep Brain Stimulation	Radiation: Injection of 15mCi of Tc-ECD and scanning by SPECT camera Behavioral: Semantic verbal fluency task performance Device: Turning off the stimulator	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Study Start Date :

Feb 1, 2006

Anticipated Primary Completion Date :

Apr 1, 2010

Anticipated Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: PD, DBS, healthy controls Patients with idiopathic PD before or after DBS surgery (during on or off-stimulation) and healthy controls.	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.

Arm

Intervention/Treatment

Other: PD, DBS, healthy controls

Patients with idiopathic PD before or after DBS surgery (during on or off-stimulation) and healthy controls.

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.

Outcome Measures

Primary Outcome Measures

CBF values in different brain regions [3 months to 2 years post-surgery]

Secondary Outcome Measures

Number of words produced in the semantic fluency task [3 months to 2 years post-surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Movement Disorders Clinic, Sheba Medical Center	Ramat Gan		Israel	52621

Sponsors and Collaborators

Sheba Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01037686

Other Study ID Numbers:

SHEBA-05-3972-SH-CTIL

First Posted:

Dec 23, 2009

Last Update Posted:

Dec 23, 2009

Last Verified:

Dec 1, 2009

Keywords provided by , ,

DBS

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Dec 23, 2009