MER Versus MRI Guidance DBS in Parkinson's Disease
Recruitment status was Recruiting
Idiopathic Parkinson's Disease (PD)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Randomized Study of Deep Brain Stimulation (DBS) Implantation Using A Microelectrode-Guided Technique Versus DBS Implantation Using MRI Guidance Alone|
- percentage improvement in the UPDRS part III motor score [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||May 2011|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|