Mapping the Target for the MRgFUS Treatment of Tremor

NCT ID: NCT04661241

Last Updated: 2022-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-10
• Study Completion Date: 2022-06-15

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.

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.

Conditions

Tremor, Essential; Parkinson's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Investigational Scan

The proposed sequence (\<15 minutes) will be added as a supplementary sequence only for the preoperative imaging if subjects agree to participate.

Group Type: EXPERIMENTAL

Automatic DRT/VIM target-recognition method using MR-SISET and ML approaches

Intervention Type: OTHER

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.

Current Clinical Practice

All patients will undergo a routine clinical preoperative MRI of the brain under general anesthesia to reduce movement artifacts.

Group Type: ACTIVE_COMPARATOR

Routine clinical MRI protocol

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sohae Chung, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone

Timothy Shepherd, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone

Locations

NYU Langone

New York, New York, United States

Countries

United States

Other Identifiers

20-00981

Identifier Type: -

Identifier Source: org_study_id