Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mapping the Target for the MRgFUS Treatment of Tremor

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: NCT04661241
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : December 10, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
The purpose of this investigation is to determine the optimal DRT/VIM target location and its safety margins based on MR-SISET imaging features by comparing with postoperative lesions and clinical outcomes in patients with tremor who will undergo the MRgFUS tremor therapy.

Condition or disease Intervention/treatment Phase
Tremor, Essential Parkinson's Disease Other: Automatic DRT/VIM target-recognition method using MR-SISET and ML approaches Other: Routine clinical MRI protocol Not Applicable

Detailed Description:

Magnetic susceptibility is an important source of contrast in MRI, which arises from the subtle field perturbations generated by inter-molecular interaction in response to an external magnetic field. The DRT tract consists mainly of axon fibers covered by myelin sheaths that cause magnetic susceptibility variations. In addition, magnetic susceptibility of fiber bundle is in fact anisotropic. Such distinctive features of the DRT can generate a unique type of susceptibility contrast with respect to its neighboring thalamic tissues, yet clinically practical protocols are lacking. This study will utilize a novel MR susceptibility-based method, termed 'MR Susceptibility Imaging with Short Echo Time (MR-SISET)' which leverages short echo times to realize high contrast for direct and individualized DRT targeting. Combined with machine learning (ML) approaches, an automatic, operator-independent DRT-recognition will be achieved. This could provide a valid support to operators in the surgical planning and significantly improve the current operative methodology.

MR imaging will be done on a 3T MRI Magnet at the NYU Langone Health. All patients will undergo a routine clinical preoperative MRI of the brain under general anesthesia to reduce movement artifacts. The proposed sequence (<15 minutes) will be added as a supplementary sequence only for the preoperative imaging for subjects who agree to participate. The operator/clinician will be blinded to the results of this study for the MRgFUS treatment. A routine clinical postoperative MRI will be performed prior to discharge by the clinician, typically the following day of the MRgFUS treatment. The severity of tremor will be assessed before and after the treatment (~6 weeks). Postoperative clinical data will be retrieved to get a surgical target lesion and clinical outcome after treatment in order to confirm our method.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: All patients in this study will be recruited from New York University Langone Health in cooperation with the NYU Neurosurgery and the Center for Neuromodulation. The Department of Neurosurgery will make initial contact with prospective patients who will undergo the MRgFUS tremor treatment. The patient's treating physician will determine suitability based on the subject's known clinical status and ability to be informed consent to participate in the study.
Masking: Single (Care Provider)
Masking Description: As a pilot study, the results of our method will be blinded to the clinician who will operate the MRgFUS tremor therapy in order to compare the locations of the proposed target, surgical lesion and stereotactic coordinates.
Primary Purpose: Other
Official Title: MRI-guided Personalized Targeting of the Ventral Intermediate Nucleus (VIM)/Dentato-rubro-thalamic Tract (DRT) for the MRgFUS Tremor Treatment
Actual Study Start Date : September 10, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
Experimental: Investigational Scan
The proposed sequence (<15 minutes) will be added as a supplementary sequence only for the preoperative imaging if subjects agree to participate.
Other: Automatic DRT/VIM target-recognition method using MR-SISET and ML approaches
The proposed sequence (<15 minutes) will be added as a supplementary sequence only for the preoperative imaging for subjects who agree to participate: a 3D multi-echo GRE sequence will be performed during a preoperative MR imaging, using the following parameters: field of view = 220x170x75 mm3, matrix = 176x136x60, 1.25-mm isotropic resolution, flip angle = 22 degrees, TR = 92 ms, 20 TEs = 1.90 - 45.98 ms with echo spacing of 2.32 ms, bandwidth = 840 Hz/pixel.

Active Comparator: Current Clinical Practice
All patients will undergo a routine clinical preoperative MRI of the brain under general anesthesia to reduce movement artifacts.
Other: Routine clinical MRI protocol
MRI will be performed using 3T scanner (Skyra, Siemens, Erlangen, Germany). All patients will undergo preoperative MRI of the brain including routine clinical MRI protocol (T1-/T2-weighted and diffusion imaging) under general anesthesia to reduce movement artifacts.




Primary Outcome Measures :
  1. Tremor improvement [ Time Frame: 6 weeks ]
    A routine clinical follow-up will be performed to assess the severity of tremor after the treatment (~ 6 weeks) by the clinician. Patients will be categorized into three groups based on their outcome: a good clinical outcome (>65% tremor improvement), a moderate outcome (>33%, but <66% tremor improvement) and a poor outcome (<33% tremor improvement).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female
  • 18 years of age or older
  • Any ethnic background
  • History of a primary diagnosis of essential tremor or Parkinson's disease
  • Present for the MRgFUS tremor treatment
  • Ability to understand and agree to informed consent as determined by referring physician

Exclusion Criteria:

  • Inability to give informed consent
  • Contraindications for MRI, including

    1. Intracranial clips
    2. Metal implants
    3. External metallic devices/objects/clips within 10 mm of the head
    4. Suspected or confirmed metal in eyes (history of welding or similar activity)
    5. Cardiac pacemaker
    6. Pregnant or potentially pregnant - pregnancy tests will be offered to women of childbearing age at no cost to the patient. (A SOC pregnancy test (Urine test) will be done for women of child bearing age if requested/required at the time of check-in at Tisch.This will be billed to the research study). The result of the test (if performed) will be added to the patient's chart in EPIC.
    7. No vulnerable populations will be enrolled.

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): NCT04661241


Contacts
Layout table for location contacts
Contact: Sohae Chung, MD 212-263-3324 sohae.chung@nyulangone.org
Contact: Timothy Shepherd, MD 212-263-8487 Timothy.Shepherd@nyulangone.org

Locations
Layout table for location information
United States, New York
NYU Langone Recruiting
New York, New York, United States, 10016
Contact: Terlika Sood, PhD    212-731-5313    Terlika.sood@nyulangone.org   
Sponsors and Collaborators
NYU Langone Health
Investigators
Layout table for investigator information
Principal Investigator: Sohae Chung, MD NYU Langone
Principal Investigator: Timothy Shepherd, MD NYU Langone
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04661241    
Other Study ID Numbers: 20-00981
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to sohae.chung@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: beginning 9 months and ending 36 months following article publication
Access Criteria: Requests may be directed to sohae.chung@nyulangone.org.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Tremor
Parkinson's Disease
MRgFUS
magnetic resonance-guided focused ultrasound
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Tremor
Essential Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations