Functional Magnetic Resonance Imaging (fMRI) During Deep Brain Stimulation (DBS) to Treat Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT01809613|
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : August 3, 2017
|Condition or disease||Intervention/treatment|
|Parkinson Disease Essential Tremor Dystonia Obsessive Compulsive Disorder||Procedure: Functional Magnetic Resonance Imaging (fMRI)|
|Study Type :||Observational|
|Actual Enrollment :||88 participants|
|Official Title:||Functional Magnetic Resonance Imaging (fMRI) During Deep Brain Stimulation (DBS) to Treat Parkinson's Disease|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||July 27, 2017|
|Actual Study Completion Date :||July 27, 2017|
Deep Brain Stimulation
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.
- Mean Score on Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 6 months after Deep Brain Stimulation ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809613
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Kendall Lee, MD, PhD||Mayo Clinic|