Mapping the Target for the MRgFUS Treatment of Tremor

Not Applicable

Completed

• Conditions: Tremor, Essential; Parkinson's Disease
• Interventions: Other: Automatic DRT/VIM target-recognition method using MR-SISET and ML approaches; Other: Routine clinical MRI protocol

• Registration Number: NCT04661241
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2020-09-10
• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-10
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-15
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-12
• Last Update Posted: 2022-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigational Scan	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 if subjects agree to participate.
Current Clinical Practice	Routine clinical MRI protocol	All patients will undergo a routine clinical preoperative MRI of the brain under general anesthesia to reduce movement artifacts.

Primary Outcome Measures

Name	Time	Method
Tremor improvement	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).

Trial Locations

Locations (1)

NYU Langone; 🇺🇸 New York, New York, United States