Mapping the Target for the MRgFUS Treatment of Tremor

NCT04661241 | Completed DMC

• 1 other identifier: 20-00981
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Tremor, Essential; Parkinson's Disease

Keywords

Tremor; Parkinson's Disease; MRgFUS; magnetic resonance-guided focused ultrasound

Outcome Measures

Primary Outcomes (1)

• Tremor improvement

  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).

  6 weeks

Study Arms (2)

Investigational Scan

EXPERIMENTAL

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

Current Clinical Practice

ACTIVE COMPARATOR

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

Other: Routine clinical MRI protocol

Interventions

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

Investigational Scan

Routine clinical MRI protocol 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.

Current Clinical Practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• 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

You may not qualify if:

• Inability to give informed consent
• Contraindications for MRI, including
• Intracranial clips
• Metal implants
• External metallic devices/objects/clips within 10 mm of the head
• Suspected or confirmed metal in eyes (history of welding or similar activity)
• Cardiac pacemaker
• 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.
• No vulnerable populations will be enrolled.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Essential Tremor; Parkinson Disease; Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sohae Chung, MD

  NYU Langone

  PRINCIPAL INVESTIGATOR

• Timothy Shepherd, MD

  NYU Langone

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 10, 2020
• Study Start: September 10, 2020
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: beginning 9 months and ending 36 months following article publication
• Access Criteria: Requests may be directed to sohae.chung@nyulangone.org.

Locations

US (1)