Functional Magnetic Resonance Imaging (fMRI) During Deep Brain Stimulation (DBS) to Treat Parkinson's Disease
This study is investigating the usefulness of using functional magnetic resonance imaging (fMRI) to monitor brain activation during deep brain stimulation for Parkinson's Disease. The study may determine the relationship between patterns of brain activation and therapeutic outcome and/or side effects.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Functional Magnetic Resonance Imaging (fMRI) During Deep Brain Stimulation (DBS) to Treat Parkinson's Disease|
- Mean Score on Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 6 months after Deep Brain Stimulation ] [ Designated as safety issue: No ]The UPDRS is a rating scale used to follow the longitudinal course of Parkinson's disease. The version of the scale used in this study has a total of 14 items; each of these item has a scale of 0-4, with 0 being no impairment, and 4 being severe impairment. All of the parts are combined to give a numeric score: 0 indicating no sign of disease, and 56, the highest score indicating severely incapacitated.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Stimulation-evoked blood-oxygen-level dependence (BOLD) signal
Functional Magnetic Resonance Imaging (fMRI) will be performed to determine the areas of BOLD signal modulation with DBS.
Procedure: Functional Magnetic Resonance Imaging (fMRI)
During the deep brain stimulation (DBS) surgery of the subthalamic nucleus within the thalamocortical basal ganglion, an additional lead extendor will be connected to the DBS electrode to allow externalization of the lead. Following confirmation of electrode location with MRI, a series of fMRI scans will be run. Total scanning time will be limited to 35 minutes.
Deep brain stimulation (DBS) of the subthalamic nucleus (STN) within the thalamocortical basal ganglion (BG) complex is an effective neurosurgical approach for treating motor symptoms of Parkinson's disease (PD). However, because the nature of its underlying mechanisms and clinical effects are not fully understood, precision targeting, decreasing adverse effects, and improving clinical outcomes represent major clinical and scientific challenges in PD and other disorders treated by DBS. Our goal is to investigate the inter-relationships between site-specific neural activation and clinical outcomes during STN DBS. To do so, we will perform non-invasive functional Magnetic Resonance Imaging (fMRI) to investigate DBS-mediated activation of thalamocortical BG network circuitry. Our proposed protocol involves the addition of intraoperative fMRI to the standard DBS protocol in order to determine the major sites of activation in the thalamocortical BG complex during application of clinically effective DBS to the dorsal and ventral regions of the STN (dSTN and ventral subthalamic nucleus (vSTN), respectively). Patients will undergo clinical assessment using the Unified Parkinson's Disease Rating Scale (UPDRS) to determine the relative efficacy of dSTN and vSTN DBS, applied during the fMRI and at every standard follow visit post-surgery. Our Specific Aims are to: (1) Identify fMRI-activated brain regions by vSTN and dSTN DBS in PD patients and (2) correlate fMRI activation with clinical outcomes (UPDRS) and side effects. With the goal of improving DBS electrode targeting for optimal and reproducible clinical outcomes, these experiments will be the first attempt to relate site-specific DBS with functional in vivo imaging data and quantitative longitudinal clinical outcome measures in PD patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01809613
|Contact: Emily Knightemail@example.com|
|Contact: Su Youne Chang, PhDfirstname.lastname@example.org|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Emily Knight 507-293-0512 email@example.com|
|Principal Investigator: Su-youne Chang, PhD|
|Principal Investigator: Kendall Lee, M.D. Phd|
|Principal Investigator:||Su Youne Chang, Ph.D.||Mayo Clinic|