NCT04661241

Mapping the Target for the MRgFUS Treatment of Tremor

MRI-guided Personalized Targeting of the Ventral Intermediate Nucleus (VIM)/Dentato-rubro-thalamic Tract (DRT) for the MRgFUS Tremor Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2020-09-10
• Primary completion: 2022-06-15
• Completion: 2022-06-15
• First posted: 2020-12-10
• Last updated: 2022-08-15

Locations

1 site across 1 country: United States