New Stereotactic Frame System for Neurosurgery

Learn more about:
Related Clinical Trial
Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics Internet-based Cognitive Behavioral Therapy for Chronic Tic Disorder and Tourette’s Disorder: a Feasibility Trial Longitudinal Impact of Stressors in Adults With Tourette Syndrome Effects of Lactobacillus Plantarum PS128 in Patients With Tourette’s Syndrome Combined CBIT and rTMS to Improve Tourette’s Syndrome Pimavanserin Treatment in TS Median Nerve Stimulation (MNS) Pilot Extinction Learning in Adults With Tourette Syndrome Observational Database on Deep Brain Stimulation in Tourette Syndrome Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome D-cycloserine Augmented Treatment for Youth With Tic Disorders Sensory Symptoms in Tourette Syndrome and Obsessive-Compulsive Disorder Atomoxetine in Patients With Tourette’s Syndrome Deep Brain Stimulation in Forel’s H Field in Tourette’s Syndrome Psychosocial Intervention for Young Children With Chronic Tics Brain Tissue Collection for Neuropathological Studies New Stereotactic Frame System for Neurosurgery Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders. Outcomes Mandate National Integration With Cannabis as Medicine Reliability and Validity of the MINI International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) Brain-Behavior Interactions in Tic Suppression Phase III Study of 5LGr to Treat Tic Disorder Effects of Ondansetron in Obsessive-compulsive and Tic Disorders I-123 Brain Studies of Serotonin Metabolism in Psychiatric Patients and Normal Volunteers Physiological Investigations of Movement Disorders Dissemination of Comprehensive Behavioral Intervention for Tics (CBIT) to Occupational Therapists: A Feasibility Study TicHelper: A Computerized Comprehensive Behavioral Intervention for Tics (CBIT) Safety Study of Galantamine in Tic Disorders Internet-based Coaching for Young Adults With Neuropsychiatric Disorders Modified Comprehensive Behavioral Intervention for Tics (M_CBIT) Incorporating teleCBIT Into a Hospital-Based Tic Program Cognitive Behavior Therapy and Habit Reversal Training for the Treatment of Chronic Tic Disorders in Children An Exploratory Study of Transcranial Magnetic Stimulation (TMS) Based on Functional Magnetic Resonance Imaging (fMRI) in the Treatment of Tic Disorder Brain Stimulation in Movement Disorders Augmentation of Brief Habit Reversal Training With D-cycloserine or Placebo Central Mechanisms in Speech Motor Control Studied With H215O PET Comparison of Keppra and Clonidine in the Treatment of Tics Brain Activation in Vocal and Motor Tics Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders Assessment of Children With Tic Onset in the Past 6 Months Repetitive Transcranial Magnetic Stimulation to Reduce Tics Guanfacine in Children With Tic Disorders Neuropsychological Functioning Among Children With Tourret’s Disorder and ADHD Investigating Circadian Rhythms in Youth With Persistent Tic Disorders The Role of Probiotics PS128 in Movement Disorders Online Mindfulness-based Tic Reduction (Phase Two) Online Mindfulness-based Tic Reduction Investigation of Neurofeedback With Real-Time fMRI in Healthy Volunteers and Patients With Hyperkinetic Movement Disorders A Handwriting Intervention Program for Children With Tic Disorders Study of Clonidine on Sleep Architecture in Children With Tourette’s Syndrome (TS) and Comorbid ADHD National Gilles De La Tourette Study Group Evaluating the Efficacy and Safety of Yi-Gan San in Children and Adolescents With Tourette’s Disorder Evaluation of a Cognitive Psychophysiological Treatment for Tourette Syndrome and Tic Disorders Magnetic Resonance Spectroscopy to Evaluate Tourette s Syndrome Group Intervention for Children With Chronic Tics Syndrome or Tourette Syndrome: CBIT vs Psycho-Educational Intervention Study of the Neurobiology of Tourette Syndrome and Related Disorders Brain Dynamics Involved in Generating Tics and Controlling Voluntary Movement Dopaminergic Effects on Cortical Function in Tourette’s (Levodopa Protocol) Developmental Phenomenology of Obsessive Compulsive Disorder and Tourette Syndrome in Children and Adolescents Online Remote Behavioural Intervention for Tics (ORBIT) CANNAbinoids in the Treatment of TICS (CANNA-TICS) A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome Internet-delivered Behaviour Therapy for Children and Adolescents With Tourette’s Disorder A Study to Evaluate the Effects of ABX-1431 on Patients With Tourette Syndrome Aripiprazole in the Treatment of Tourette’s Syndrome Aripiprazole in Children and Adolescents With Chronic Tic Disorder or Tourette’s Disorder Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder Randomized Study of Pergolide in Children With Tourette Syndrome Phase II Pilot Controlled Study of Short Vs Longer Term Pimozide (Orap) Therapy in Tourette Syndrome tDCS in Tourette (TIC-TDCS) Anger Control Training for Youth With Tourette Syndrome Safety and Tolerability Study of NBI-98854 for the Treatment of Subjects With Tourette Syndrome Neurofeedback for Tourette Syndrome Brain Stimulation for the Treatment of Tourette Syndrome Study of Tics in Patients With Tourette’s Syndrome and Chronic Motor Tic Disorder Timing of Voluntary Movement in Patients With Tourette Syndrome and Chronic Tic Disorder Repetitive Transcranial Magnetic Stimulation of the Posterior Parietal Cortex in Patients Suffering From Gilles de la Tourette Syndrome Methylphenidate for Treating Children With ADHD and Tourette Syndrome Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Tourette Syndrome and Seasonality (Stagionalità Tourette) Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Role of the Sensory Experience in Generating Motor Tics in Tourette Syndrome Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder Proof of Concept Study of an Oral Orthotic to Reduce Tic Severity in Chronic Tic Disorder and Tourette Syndrome Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents Multi-site Transcranial Magnetic Stimulation Therapy of the Supplementary Motor Area in Children With Tourette Syndrome Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome A Randomized, Placebo-controlled, Tourette Syndrome Study. A Trial of Bilateral Deep Brain Stimulation to the Globus Pallidus Internum in Tourette Syndrome A Study of the Effectiveness and Safety of Tetrabenazine MR in Pediatric Subjects With Tourette’s Syndrome An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome. Thalamic Deep Brain Stimulation for Tourette Syndrome Exploration of Glutamatergic System With PET Radiotracer in Gilles de la Tourette Patients: Pilot Study (GlutaTour) ABF Tourette’s Disorder Post Marketing Surveillance Study Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome Brain Activity Associated With Tics in Patients With Tourette Syndrome Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome Internet-based Behaviour Therapy for Tourette’s Disorder and Chronic Tic Disorder Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria Response Inhibition in Tourette Syndrome Alternatives for Reducing Tics in TS: A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents. Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome Pallidal Stimulation and Gilles de la Tourette Syndrome Developing New Treatments for Tourette Syndrome: Therapeutic Trials With Modulators of Glutamatergic Neurotransmission Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device – Safety and Feasibility Study for the Treatment of Tourette Syndrome Pilot Study of the Modified Atkins Diet for Tourette Syndrome Trial to Evaluate the Long-term Efficacy of Oral Aripiprazole in the Treatment of Pediatric Subjects With Tourette’s Disorder Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome Pilot Study for Use of Dysport in Treatment of Vocal Tics in Patients With Tourette’s Syndrome A Study to Examine the Efficacy of a Therapeutic THX-110 for Tourette Syndrome Open Label Trial of Aripiprazole in Children and Adolescents With Tourette’s Disorder Open-label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome Study Evaluating The Safety And Efficacy Of PF-03654746 In Adult Subjects With Tourette’s Syndrome Safety & Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Hypersensitivity in Tourette Syndrome Role of Frontal Cortex in the Pathophysiology of Gilles de la Tourette Syndrome (GTS) Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Safety and Efficacy Study of NBI-98854 in Adults With Tourette Syndrome VoIP Delivered Behavior Therapy for Tourette Syndrome Safety and Efficacy Study of NBI-98854 in Children and Adolescents With Tourette Syndrome Study of ABX-1431 in Adult Patients With Tourette Syndrome or Chronic Motor Tic Disorder Subthalamic Stimulation in Tourette’s Syndrome Study of GABA-A Receptors in the Generation of Tics in Patients With Tourette’s Syndrome Transcranial Magnetic Stimulation (TMS) for Individuals With Tourette’s Syndrome Neural Correlates of Sensory Phenomena in Tourette Syndrome Sensory Symptoms in Tourette Syndrome Tourette Syndrome Deep Brain Stimulation The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Tourette Syndrome Safety, Tolerability, Pharmacokinetic, and Efficacy Study of AZD5213 in Adolescents With Tourette’s Disorder Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Tourette’s Syndrome Facial Expression Recognition of Emotion and Categorization of Emotional Words in Gilles de la Tourette’s Syndrome Thalamic Deep Brain Stimulation for Tourette Syndrome Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome The Effect and Safety of Plum-blossom Needle for Tourette Syndrome Proof-of-Concept Safety Study of CPP-109 (Vigabatrin) for Treatment Refractory Tourette’s Disorder Ecopipam Treatment of Tourette Syndrome High Frequency Stimulation of the GPi or Thalamus in Tourette’s Syndrome Computerized Working Memory Training in Children With ADHD and Comorbid Tourette Syndrome Optimising Anterior Pallidal Deep Brain Stimulation for Tourette’s Syndrome MRI Study of Tic Remission in Tourette Syndrome Thalamic Deep Brain Stimulation for the Treatment of Refractory Tourette Syndrome Selective Microbiota Transplantation for Tourette’s Syndrome Parent Behavioral Training for Disruptive Behaviors in Tourette Syndrome A Pilot Study Of SD-809 (Deutetrabenazine) In Moderate To Severe Tourette Syndrome (TS) Impulsivity in Tourette Syndrome : Behavioral and Neuroimaging Study Developing Cognitive Training for Tourette Syndrome A Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of SNC-102 in Subjects With Tourette Syndrome Safety and Efficacy of Cannabis in Tourette Syndrome Activity in Tourette Syndrome FAAH Inhibitor Trial for Adults With Tourette Syndrome Open-Trial of EPI-743 for Adults With Tourette Syndrome Omega-3 Fatty Acids in Tourette’s Disorder Do Mirror Neurons Play a Role in Tourette Syndrome Physiopathology? A Pilot Study. Apathy in Tourette Syndrome and Changes in Quality of Life Sensory Processing in Tourette Syndrome The Pathophysiology of Tourette Syndrome: a Multimodal Study Behavioral Therapy for Tourette Syndrome Behavioral Therapy for Children and Adolescents With Tourette Syndrome Ecopipam Treatment of Tourette’s Syndrome in Subjects 7-17 Years Transcranial Magnetic Stimulation for Children With Tourette’s Syndrome

Brief Title

New Stereotactic Frame System for Neurosurgery

Official Title

A Re-attachable Stereotactic Frame System for Clinical Interventive Neurosurgery

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.
    

Detailed Description

      Aims:

      This study will evaluate a new stereotactic device (D1 stereotactic system) designed to
      address shortcomings of current stereotactic systems by using a novel surface-mounted
      stereotactic system that is comparatively small, lightweight, user-friendly, and comparable
      in precision and accuracy to current clinical systems.

      Methods:

      Subjects will be recruited exclusively from adult subjects with a neurological disease. These
      subjects will be identified preoperatively from DBS clinical subjects. Each subject will
      undergo an evaluation by the Mayo Clinic Deep Brain Stimulation Committee (comprised of
      neurologists, neuropsychologists, psychiatrists, neurosurgeons, and radiologists) to receive
      a DBS surgery at Mayo Clinic - Rochester for the treatment of a neurological disease. All
      subjects will be pre-screened against the standard Mayo Clinic inclusion/exclusion criteria
      for DBS surgery through face-to-face interviews. Once a subject has been identified, the
      Study Coordinator will contact the subject for interest in participation in the study.

      Step-by-Step Schedule:

      Skull Anchor Key Attachment Location: St. Mary Hospital - Subject Preparation Room

        1. Superior portion of the head, the hair is clipped off in the area where Skull Anchor Key
           would be placed. The clipped area and surrounding region is prepped in usual sterile
           fashion. This begins subject participation in the protocol.

        2. The MR Localizer Box is placed upside down and the Skull Anchor Key is placed within its
           slot in the MR Localizer Box and screwed in using MR compatible screws.

        3. The apparatus is positioned on the subject head and allowed to rest such that the Skull
           Anchor Key is midline and the ear bars lie parallel to the external auditory meatus
           taking caution to prevent the bottom surface of the Skull Anchor Key or the safety caps
           from becoming non sterile.

        4. The Z value of the ear bars is adjusted such that the ear probes are at same horizontal
           level as the external auditory meatus. The ear bars are gently pushed into the external
           auditory meatus on both sides such that it is snug but comfortable to the subject.
           (NOTE: If required, the Y position of the ear bars may be readjusted at this step in
           situations such as the anterior N fiducial bars hitting the forehead of the subject).

        5. After confirming accurate initial placement of the MR Localizer Box, the sites of skull
           screw and pins placement are marked using a surgical pen with the guide Skull Anchor Key
           which has holes instead of screws and pins acting as reference guide. The MR Localizer
           Box is then removed and each of the pen marked site receives an injection of local
           anesthetic.

        6. Following local anesthetic application, the ear bars are removed from the ear while an
           assistant supports the MR Localizer Box. The MR Localizer Box is gradually lowered to
           allow the pins to penetrate scalp until it rests on the bone. At this point, titanium
           self-tapping screws are gently screwed in through the hole on each of the 2 angled legs
           of the Skull Anchor Key until the Skull Anchor Key is level and secure.

        7. The subject is then transferred to the MR/CT Imaging Facility for target planning.

      MRI Acquisition and Target Planning Location: St. Mary Hospital - Neuroradiology Facility

        1. Once in MR suite, the subject rests their head in a custom made MR headrest which sits
           within the lower portion of RF coil. The headrest holds the axis of MR Localizer Box
           parallel to the axis of MR gantry and allows the frame to be held securely during the MR
           imaging.

        2. The subject is positioned in a MR scanner in a supine position.

        3. An anatomical image volume is acquired. The field of view region is adjusted to ensure
           the MR Localizer Box fiducials are visible in the MR images and then all images are
           acquired.

        4. The images are then transferred to the surgical planning computer.

        5. Following image acquisition, the images are reviewed by the surgical team to judge
           whether they are suitable for surgical planning. (If found unsuitable, the imaging and
           review is repeated.) Once satisfactory images are obtained, the subject is moved to the
           subject preparation room where the MR Localizer Box is detached from the KEY.

        6. A DBS surgical plan, comprised of the electrode stereotactic target coordinates and an
           optimal trajectory is created by the navigational software. The plan is documented and
           shared with the surgical team.

        7. The subject is then transferred to the operating room for DBS electrode implantation.

      DBS Electrode Implantation Location: St. Mary Hospital - Operating Room

        1. The subject is shifted to the operating room.

        2. The D1 stereotactic device is attached to the Skull Anchor Key and the X, Y, Z, Arc and
           Collar angles will be adjusted based on MR planned coordinates.

        3. Standard procedure is followed for making the incision and burr hole, putting in the DBS
           electrode, electrophysiologic target confirmation (as required) and securing the
           electrode in place.

        4. A C-arm is then used to obtain a lateral view radiograph to confirm correct placement of
           the DBS electrode as assessed by the alignment of the tip of the DBS electrode with
           X-ray reticules on the stereotactic device.

        5. Above steps are repeated for additional DBS electrode insertion.

        6. After securing the last DBS electrode the stereotactic device is removed from the KEY.
           All DBS electrodes are then coiled and secured under the skin or are tunneled beneath
           the skin of the scalp and neck for battery placement as currently practiced. All
           surgical incisions are then sutured.

        7. The CT Localizer Box is attached to the Skull Anchor Key to acquire a post-operative CT
           scan.

        8. The subject is then transferred to the Neuroradiology Facility for post-operative CT
           imaging.

      CT Confirmation and CT Localizer Box and KEY Removal Location: St. Mary Hospital -
      Neuroradiology Facility

        1. With the subject in the CT imaging room the subject is positioned supine in the CT
           scanner to acquire a postoperative anatomical image volume to confirm the placement of
           the DBS electrode placement using planning software normally used for neurosurgical
           procedures.

        2. Immediately following the CT scan, the subject is taken to the preparation room for
           removal of the CT Localizer Box, the Skull Anchor Key, and post-removal treatments. The
           self-tapping titanium screws are removed and the surgical site is treated appropriately.

      Power Statement:

      This is a pilot study with a unique subject cohort.

      Data Analysis Plan:

      The effectiveness of the D1 Stereotactic System in accurately implanting DBS electrodes in
      adults approved for DBS surgery at Mayo Clinic for treatment of a neurological disease will
      be evaluated by analyzing the following:

        1. A 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.
           Unpaired t-test will be used to determine whether the difference is significantly
           different or not.

        2. 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. Paired t-test will be used for 10 patient data.

        3. 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 will be given to each subject after DBS surgery and removal
           of the device to assess their overall experience with device and surgery.

      Data Exclusion Criteria: If any surgical plan is changed in operating room (i.e., target
      coordinate, trajectory), the data will be excluded. However, the change of DBS electrode
      depth will be accounted as valid data.
    


Study Type

Interventional


Primary Outcome

3D Euclidian distance error


Condition

Parkinson Disease

Intervention

DBS Electrode Implantation using D1 Sterotactic System

Study Arms / Comparison Groups

 D1 Stereotactic System Assessment
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

10

Start Date

May 2021

Completion Date

June 2022

Primary Completion Date

June 2022

Eligibility 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.
      

Gender

All

Ages

18 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

Kai Miller, MD, PhD, 507-422-2121, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04283812

Organization ID

18-011914


Responsible Party

Principal Investigator

Study Sponsor

Mayo Clinic

Collaborators

 NaviNetics Inc.

Study Sponsor

Kai Miller, MD, PhD, Principal Investigator, Mayo Clinic


Verification Date

September 2020