MER Versus MRI Guidance DBS in Parkinson's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01883973|
Recruitment Status : Unknown
Verified June 2013 by Ashwin Viswanathan, Baylor College of Medicine.
Recruitment status was: Recruiting
First Posted : June 21, 2013
Last Update Posted : June 21, 2013
|Condition or disease|
|Idiopathic Parkinson's Disease (PD)|
Patients who have been randomized into Group 1 will undergo DBS implantation while awake. On the morning of surgery, the patient will undergo placement of the stereotactic head frame under local anesthesia. A CT scan will be performed for stereotactic planning, which will be fused to a preoperatively obtained MRI. The coordinates for the planned target will be selected using standard coordinates based on known relationships with the anterior commissure - posterior commissure plane, along with anatomical structures visualized on the MRI scan.
The surgery will be performed with the patient awake. Two simultaneous microelectrode tracks will be used for each DBS electrode to be implanted. If neither electrophysiological recording is adequate, additional MER tracks may be performed. Macro-stimulation will also be used to evaluate for clinical efficacy and stimulation induced side effects. The DBS electrode will be placed into the track with the optimal electrophysiological and clinical findings. The identical procedure will be followed for the contralateral side. A post-operative stereotactic CT scan will be performed to assess lead location and evaluate for intracranial bleeding.
Patients who have been randomized into Group 2 will undergo DBS implantation under general anesthesia in an operating room equipped with an intraoperative MRI. Once under anesthesia the patient will be placed into a rigid head holder, and an MRI scan will be obtained to register the navigation system. The location for the holes in the skull will be identified, and the surgery will be commenced. Once the holes have been made in the skull and the dura has been opened, a second MRI scan will be obtained to identify the target. A ceramic stylet will then be stereotactically introduced to the target, and a third MRI sequence will be performed to verify the stylet is indeed at the desired target. The DBS electrode will then be implanted after removing the stylet. A post-operative stereotactic CT scan will be performed to assess lead location and evaluate for intracranial bleeding.
Neither of the surgical groups will undergo investigational procedures. Both surgical techniques utilize FDA approved devices, used in the manner for which FDA approval was given. They represent two different, but both accepted, means for implanting deep brain stimulator electrodes.
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Randomized Study of Deep Brain Stimulation (DBS) Implantation Using A Microelectrode-Guided Technique Versus DBS Implantation Using MRI Guidance Alone|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||December 2014|
Will undergo DBS implantation in the awake state using a frame based stereotactic technique and intraoperative microelectrode recording to guide final lead placement.
Will undergo DBS implantation under general anesthesia using anatomical targeting in an operating room equipped with an intraoperative MRI to guide electrode placement
- percentage improvement in the UPDRS part III motor score [ Time Frame: from baseline to 6 months ]The primary outcome measure for this study is the percentage improvement in the Unified Parkinson Disease Rating Scale (UPDRS) part III motor score from baseline to 6 months in patients who receiving stimulation in the "OFF" medication state. Secondary outcome measures include rate of radiographically visible intracranial hemorrhage and changes in neurocognitive function and quality of life testing. The student's two sample t-test will be used to perform the statistically comparisons.
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): NCT01883973
|Contact: Ashwin Viswanathan, MDfirstname.lastname@example.org|
|Contact: Erica Smith-Gloyd, MSemail@example.com|
|United States, Texas|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|Sub-Investigator: Joseph Jankovic, MD|
|Sub-Investigator: Mary Ann Thenganatt, MD|
|Principal Investigator:||Ashwin Viswanathan, MD||Baylor College of Medicine|
|Principal Investigator:||Joohi Jimenez-Shahed, MD||Baylor College of Medicine|