New Stereotactic Frame System for Neurosurgery

NCT04283812 | Withdrawn DMC FDA Device

• 1 other identifier: 18-011914
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Parkinson Disease; Essential Tremor; Dystonia; Tourette Syndrome; Obsessive-Compulsive Disorder

Keywords

deep brain stimulation; sterotactic surgery; neurological disorders; stereotactic instruments

Outcome Measures

Primary Outcomes (4)

• 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

  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.

Study Arms (1)

D1 Stereotactic System Assessment

EXPERIMENTAL

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

Interventions

DBS Electrode Implantation using D1 Sterotactic System DEVICE

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.

D1 Stereotactic System Assessment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be adult subjects with medically intractable neurological disorder who have been approved for DBS surgery by the interdisciplinary Mayo DBS committee.
• Competent and willing to provide signed, informed consent to participate in the study.
• Competent and willing to provide written, informed consent to participate in the study.

You may not qualify if:

• Pregnant subjects, prisoners, individuals ages less than 18 and any subjects identified as unsuitable for DBS surgery by the Mayo Clinic DBS committee.
• Subjects unable to communicate with the investigator and staff.
• Any health condition that in the investigator's opinion should preclude participation in this study.

Sponsors & Collaborators

• Mayo Clinic: lead
• NaviNetics Inc.: collaborator

Related Publications (13)

• 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.

  PMID: 29288853 BACKGROUND

• 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.

  PMID: 17534136 BACKGROUND

• 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.

  PMID: 26227179 BACKGROUND

• 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.

  PMID: 30124202 BACKGROUND

• 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.

  PMID: 7041006 BACKGROUND

• 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.

  PMID: 26679880 BACKGROUND

• 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.

  PMID: 6374493 BACKGROUND

• 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.

  PMID: 3543519 BACKGROUND

• 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.

  PMID: 23441210 BACKGROUND

• 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.

  PMID: 21160241 BACKGROUND

• 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.

  PMID: 24933029 BACKGROUND

• 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.

  PMID: 17489644 BACKGROUND

• 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.

  PMID: 24814855 BACKGROUND

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor; Dystonia; Tourette Syndrome; Obsessive-Compulsive Disorder; Nervous System Diseases

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tic Disorders; Heredodegenerative Disorders, Nervous System; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Anxiety Disorders

Study Officials

• Kai Miller, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No other parties will be masked
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 23, 2020
• First Posted: February 25, 2020
• Study Start: January 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share