Sponsor study identifier
interventional
0
0 countries
N/A
Study Start
January 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study is designed to demonstrate an in-house developed re-attachable stereotactic system that can markedly reduce the overall deep brain stimulation (DBS) procedure time to greatly facilitate subject access to neurosurgical restorative therapies. Subjects will consist exclusively of individuals who have been approved to undergo deep brain stimulation surgery for the treatment of a neurological disorder at Mayo Clinic - Rochester MN. This study is a quantitative comparative, between-subject study enrolling approximately 10 subjects.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 23, 2020
Actual (reported)February 25, 2020
Actual (reported)January 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
3D Euclidian distance error
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.
Within 1 month post-DBS surgery.
Trajectory accuracy
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.
Within 1 month post-DBS surgery.
Operating room time
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
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Ben-Haim S, Falowski SM. Evaluation of Patient Perspectives Toward Awake, Frame-Based Deep-Brain Stimulation Surgery. World Neurosurg. 2018 Mar;111:e601-e607. doi: 10.1016/j.wneu.2017.12.122. Epub 2017 Dec 28.
Bjartmarz H, Rehncrona S. Comparison of accuracy and precision between frame-based and frameless stereotactic navigation for deep brain stimulation electrode implantation. Stereotact Funct Neurosurg. 2007;85(5):235-42. doi: 10.1159/000103262. Epub 2007 May 25.
Kai Miller, MD, PhD
Mayo Clinic
0 participants (actual enrollment reported by the registry).
First Submitted
February 23, 2020
First Posted
February 25, 2020
Study Start
January 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Within 1 month post-DBS surgery.
Comfort level questionnaire
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.
Within 1 month post-DBS surgery.
Contact the study team to confirm eligibility.
Bot M, van den Munckhof P, Bakay R, Sierens D, Stebbins G, Verhagen Metman L. Analysis of Stereotactic Accuracy in Patients Undergoing Deep Brain Stimulation Using Nexframe and the Leksell Frame. Stereotact Funct Neurosurg. 2015;93(5):316-25. doi: 10.1159/000375178. Epub 2015 Jul 29.
Edwards CA, Rusheen AE, Oh Y, Paek SB, Jacobs J, Lee KH, Dennis KD, Bennet KE, Kouzani AZ, Lee KH, Goerss SJ. A novel re-attachable stereotactic frame for MRI-guided neuronavigation and its validation in a large animal and human cadaver model. J Neural Eng. 2018 Dec;15(6):066003. doi: 10.1088/1741-2552/aadb49. Epub 2018 Aug 20.
Goerss S, Kelly PJ, Kall B, Alker GJ Jr. A computed tomographic stereotactic adaptation system. Neurosurgery. 1982 Mar;10(3):375-9. doi: 10.1227/00006123-198203000-00014.
Grahn PJ, Goerss SJ, Lujan JL, Mallory GW, Kall BA, Mendez AA, Trevathan JK, Felmlee JP, Bennet KE, Lee KH. MRI-Guided Stereotactic System for Delivery of Intraspinal Microstimulation. Spine (Phila Pa 1976). 2016 Jul 1;41(13):E806-E813. doi: 10.1097/BRS.0000000000001397.
Kelly PJ, Kall BA, Goerss S. Computer simulation for the stereotactic placement of interstitial radionuclide sources into computed tomography-defined tumor volumes. Neurosurgery. 1984 Apr;14(4):442-8. doi: 10.1227/00006123-198404000-00009.
Kelly PJ, Sharbrough FW, Kall BA, Goerss SJ. Magnetic resonance imaging-based computer-assisted stereotactic resection of the hippocampus and amygdala in patients with temporal lobe epilepsy. Mayo Clin Proc. 1987 Feb;62(2):103-8. doi: 10.1016/s0025-6196(12)61877-1.
Knight EJ, Min HK, Hwang SC, Marsh MP, Paek S, Kim I, Felmlee JP, Abulseoud OA, Bennet KE, Frye MA, Lee KH. Nucleus accumbens deep brain stimulation results in insula and prefrontal activation: a large animal FMRI study. PLoS One. 2013;8(2):e56640. doi: 10.1371/journal.pone.0056640. Epub 2013 Feb 18.
Konrad PE, Neimat JS, Yu H, Kao CC, Remple MS, D'Haese PF, Dawant BM. Customized, miniature rapid-prototype stereotactic frames for use in deep brain stimulator surgery: initial clinical methodology and experience from 263 patients from 2002 to 2008. Stereotact Funct Neurosurg. 2011;89(1):34-41. doi: 10.1159/000322276. Epub 2010 Dec 15.
Min HK, Ross EK, Lee KH, Dennis K, Han SR, Jeong JH, Marsh MP, Striemer B, Felmlee JP, Lujan JL, Goerss S, Duffy PS, Blaha C, Chang SY, Bennet KE. Subthalamic nucleus deep brain stimulation induces motor network BOLD activation: use of a high precision MRI guided stereotactic system for nonhuman primates. Brain Stimul. 2014 Jul-Aug;7(4):603-607. doi: 10.1016/j.brs.2014.04.007. Epub 2014 May 2.
Okun MS, Fernandez HH, Rodriguez RL, Foote KD. Identifying candidates for deep brain stimulation in Parkinson's disease: the role of the primary care physician. Geriatrics. 2007 May;62(5):18-24.
Wang DD, Lau D, Rolston JD, Englot DJ, Sneed PK, McDermott MW. Pain experience using conventional versus angled anterior posts during stereotactic head frame placement for radiosurgery. J Clin Neurosci. 2014 Sep;21(9):1538-42. doi: 10.1016/j.jocn.2014.02.009. Epub 2014 May 6.
Primary Completion
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 3, 2022
Record last verified: 2022-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: