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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01037686
First received: September 29, 2009
Last updated: December 22, 2009
Last verified: December 2009
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • CBF values in different brain regions [ Time Frame: 3 months to 2 years post-surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of words produced in the semantic fluency task [ Time Frame: 3 months to 2 years post-surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2006
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037686

Contacts
Contact: Sharon Hassin, MD 97235305791 sharon.hassin@sheba.health.gov.il
Contact: Yafit Kuttner, B.Sc 97235304753 yafitkuttner@yahoo.com

Locations
Israel
Movement Disorders Clinic, Sheba Medical Center Recruiting
Ramat Gan, Israel, 52621
Contact: Sharon Hassin, MD    97235305791    sharon.hassin@sheba.health.gov.il   
Contact: Yafit Kuttner, B.Sc    97235304753    yafitkuttner@yahoo.com   
Principal Investigator: Sharon Hassin, MD         
Sponsors and Collaborators
Sheba Medical Center
  More Information

No publications provided

Responsible Party: Dr. Sharon Hassin, principal investigator, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01037686     History of Changes
Other Study ID Numbers: SHEBA-05-3972-SH-CTIL
Study First Received: September 29, 2009
Last Updated: December 22, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
PD
DBS

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 26, 2014