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New Stereotactic Frame System for Neurosurgery

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04283812
Recruitment Status : Not yet recruiting
First Posted : February 25, 2020
Last Update Posted : April 13, 2020
Sponsor:
Collaborator:
NaviNetics Inc.
Information provided by (Responsible Party):
Kai J. Miller, Mayo Clinic

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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): NCT04283812


Contacts
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Contact: Matthew Hoplin 507-422-2121 hoplin.matthew@mayo.edu
Contact: Kendall Lee, MD, PhD 507-284-7852 Lee.Kendall@mayo.edu

Locations
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United States, Minnesota
Kai Miller
Rochester, Minnesota, United States, 55905
Contact: Kendell H Lee, MD, PhD    507-284-7852    Lee.Kendell@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
NaviNetics Inc.
Investigators
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Principal Investigator: Kai Miller, MD, PhD Mayo Clinic
Additional Information:
Publications:

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Responsible Party: Kai J. Miller, Principle Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04283812    
Other Study ID Numbers: 18-011914
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Kai J. Miller, Mayo Clinic:
deep brain stimulation
sterotactic surgery
neurological disorders
stereotactic instruments
Additional relevant MeSH terms:
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Parkinson Disease
Dystonia
Tourette Syndrome
Essential Tremor
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Personality Disorders
Mental Disorders
Anxiety Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Tic Disorders
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Neurodevelopmental Disorders