New Stereotactic Frame System for Neurosurgery
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|ClinicalTrials.gov Identifier: NCT04283812|
Recruitment Status : Not yet recruiting
First Posted : February 25, 2020
Last Update Posted : April 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Essential Tremor Dystonia Tourette Syndrome Obsessive-Compulsive Disorder||Device: DBS Electrode Implantation using D1 Sterotactic System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||No other parties will be masked|
|Primary Purpose:||Device Feasibility|
|Official Title:||A Re-attachable Stereotactic Frame System for Clinical Interventive Neurosurgery|
|Estimated Study Start Date :||May 2020|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: D1 Stereotactic System Assessment
Participants in the clinical study will consist of subjects approved to undergo deep brain stimulation surgery for the treatment of a neurological disorder at Mayo Clinic. Subjects will have a Key secured to their skull for attachment of an MRI-compatible localizer box or D1 stereotactic frame. 3D Euclidian distance error(s), trajectory accuracy(s), operating room time, and comfort level of the system will be assessed.
Device: DBS Electrode Implantation using D1 Sterotactic System
Treatment intervention will consist of subjects undergoing Mayo Clinic standard deep brain stimulation surgery specific to their diagnosed neurological disorder consisting of implantation of stimulating electrodes using the D1 stereotactic system.
- 3D Euclidian distance error [ Time Frame: Within 1 month post-DBS surgery. ]3D Euclidian distance error between the MR planned coordinate (XP, YP, ZP) and CT confirmed actual DBS coordinate (XA, YA, ZA) will be calculated. The 3D distance error comparable or lower to conventional system will be accounted as success criteria.
- Trajectory accuracy [ Time Frame: Within 1 month post-DBS surgery. ]A trajectory accuracy will be determined by comparing Collar Angle (CA) and Arc Angle (AA) between MR planned angles (CAP and AAP) and CT confirmed actual angles (CAA and AAA). The non-significant difference between MR planned and CT confirmed angles will be accounted as success criteria.
- Operating room time [ Time Frame: Within 1 month post-DBS surgery. ]Operating room time will be counted and compared to conventional procedure (using Leksell frame). The average operating room time will be compared between conventional procedure and D1 Stereotactic System procedure. Significantly lower operating room time will be accounted as success criteria
- Comfort level questionnaire [ Time Frame: Within 1 month post-DBS surgery. ]Comfort level questionnaire will be given to each subject after DBS surgery and removal of the device to assess their overall experience with device and surgery.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283812
|Contact: Matthew Hoplinemail@example.com|
|Contact: Kendall Lee, MD, PhD||507-284-7852||Lee.Kendall@mayo.edu|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Kendell H Lee, MD, PhD 507-284-7852 Lee.Kendell@mayo.edu|
|Principal Investigator:||Kai Miller, MD, PhD||Mayo Clinic|