Mapping the Target for the MRgFUS Treatment of Tremor

NYU Langone Health

Status

Completed

Conditions

Tremor, Essential

Parkinson's Disease

Treatments

Other: Routine clinical MRI protocol

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04661241

20-00981

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.