Electrophysiological Recordings of Deep Brain Stimulation in the Basal Ganglia (DBSMER)
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|ClinicalTrials.gov Identifier: NCT03088592|
Recruitment Status : Unknown
Verified March 2017 by Madelon Petersen, St. Joseph's Hospital and Medical Center, Phoenix.
Recruitment status was: Recruiting
First Posted : March 23, 2017
Last Update Posted : March 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Device: Deep Brain Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Electrophysiological Recordings of Deep Brain Stimulation in the Basal Ganglia|
|Actual Study Start Date :||February 1, 2016|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||August 2019|
Deep Brain Stimulation
After informed consent is obtained, the patients will undergo routine DBS pre-operative evaluation and diagnostic testing. This includes a pre-operative 3T-MRI with and without gadolinium as well as pre-operative medical clearance by the patient's PCP or general practitioner and/or other medical specialist if necessary. They will also receive a baseline clinical evaluation including both motor function (Unified Parkinson's Disease Rating Scale on and off anti-parkinsonian medication) quality of life assessment (Parkinson's disease Questionnaire-39) and a full neuropsychological evaluation, if not already completed as part of the routine DBS candidacy evaluation within 2 months of surgery. Subjects will have medical clearance from their specialists and be be evaluated by an internal medicine physician prior to surgery and cleared to proceed.
Device: Deep Brain Stimulation
Subjects will have awake or asleep DBS surgery with STN or GPi placement. Microelectrode recordings will define the electrophysiological target prior to lead implantation. Cortical recordings will be done using µECoG grids (2.0 x 0.8 cm) placed over the cortex through the same burr hole used for lead implantation. Neural recordings will be made continuously throughout the procedure: before, during, and after DBS, and at all levels of anesthesia. A pulse generator will be connected and implanted either during the operation or within 7-10 days post-operatively. Subjects will be admitted overnight for observation with anticipated discharge the next morning. The researchers will also be collecting other routine data points (length of surgery, stereotactic accuracy, length of hospital stay, and post-operative complications).
Other Name: Activa PC Neurostimulator Model 37601 (Medtronic)
- Neural Recordings [ Time Frame: pre-operative; intra-operative ; 10-14 post-operative; 12 week post-operative; 6 months post-operative ]Simultaneous neural recordings from sub-cortical structures (e.g. subthalamic nucleus [STN] or globus pallidus internus [GPi]) and the cerebral cortex will be collected. Recordings include action potentials and local field potentials from sub-cortical structures while subdural microelectrocorticography grids will be used to record local field potential from the cerebral cortex. Time, frequency, and phase relationships between action potentials and local field potentials will also be studied in the context of the level of anesthesia. Analysis of these simultaneous recordings, including assessing any changes, may provide insight in the pathology of PD and the mechanism of DBS.
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): NCT03088592
|Contact: Margaret M Lambert, RN, BSNfirstname.lastname@example.org|
|United States, Arizona|
|St. Joseph's Hospital and Medical Center||Recruiting|
|Phoenix, Arizona, United States, 85013|
|Contact: Margaret M Lambert, RN, BSN 602-406-3755 email@example.com|
|Principal Investigator: Francisco A Ponce, MD|
|Sub-Investigator: Zaman Mirzadeh, MD|
|Principal Investigator:||Francisco A Ponce, MD||Barrow Brain and Spine physician with SJHMC privileges|