Visualization of Neural Targets With 3T MRI

Neuro-Degenerative Disease Clinical Trial

Official title:

Visualization of Neural Targets With 3T MRI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05175417
• Other study ID #: 21-6105
• Status: Recruiting
• Start date: January 29, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University Health Network, Toronto
• Contact: Tasnuva T Hoque, BSc
• Phone: 4166035800
• Email: tasnuva.hoque[@]uhnresearch.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Functional neurosurgery is dedicated to modulating aberrant neural circuits associated with a wide range of neurological conditions. Recently, technological advances in MRI have permitted marked improvements in the direct visualization of neural targets, which is necessary for the accurate targeting in functional neurosurgery procedures.

This research study focuses on imaging patient brains before their scheduled procedures by using a 3 tesla (T) MRI to provide higher resolution and quality brain images. The reason for this study is to assess the image quality using different MRI sequences or settings to improve the image resolution of the most common functional neurosurgery targets (e.g., subthalamic nucleus, globus pallidus, and thalamus) and compare the image quality of the brains in patients with healthy controls. Performing a preoperative MRI is standard-of-care for patients indicated for deep brain stimulation (DBS), gamma knife radiosurgery (GKRS), radiofrequency ablation (RFA), magnetic resonance-guided focused ultrasound (MRgFUS). MRI sequence parameters shown to improve the image quality of different neural structures in a recent literature review (Boutet et al. 2021) will be reproduced on the 3T MRI at Toronto Western Hospital.

Description:

This is an exploratory prospective experimental study that will assess the ability of different MRI sequences to visualize common functional neurosurgical targets. Some neural structures (i.e., STN) are sometimes not visualized as well, particularly in older patients, when compared to healthy controls. The findings from this study should help in identifying the advanced sequences for direct visualization of these targets, that could then be used for improved preoperative planning of functional neurosurgical procedures.

Several advanced MRI sequences will be conducted when imaging patients or healthy participant. All advanced sequences have previously been published in the literature as viable, safe preoperative planning sequences for functional neurosurgical treatments at other centres. All MRI scans in this study will be acquired at the Toronto Western Hospital (TWH). For example, structural scans using sequences that can null or not receive signals from fluids in the brain and reduce geometric distortion (i.e., fluid attenuated inversion recovery (FLAIR)), null white matter signals (i.e., fast gray matter acquisition T1 inversion recovery (FGATIR)), and enhance the visualization of iron concentrated neural structures (i.e., quantitative susceptibility mapping (QSM)) will be performed. These advanced sequences will be compared to conventional structural MRI sequences (i.e., T1-weighted (T1W) or T2-weighted (T2W)) that are typically used for anatomical purposes and direct visualization of neural structures.

Ultimately, results from this study should enhance quality of care, clinical benefits, and data quality.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: August 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 85 years of age.

• Preparing to undergo a functional neurosurgical intervention (e.g., DBS, RFA, GKR or MRgFUS) at TWH (not applicable for healthy volunteers).

• Participants must be able to understand the purpose of this research and must sign the informed consent form.

• Participants must understand that the role of this research is to enhance our understanding of brain functioning and that he/she will not directly or indirectly benefit from the study.

Exclusion Criteria:

• Contraindication for an MRI (e.g., implanted cardiac device, metal in eyes, aneurysm clip, etc.).

• Participants who have serious cognitive or psychological impairments and cannot give informed consent.

• Participants who are unable to communicate effectively or efficiently (e.g., patients suffering from speech deficits (dysarthria, aphasia) or are non-English speaking).

Related Conditions & MeSH terms

• Neuro-Degenerative Disease
• Neurodegenerative Diseases

Intervention

Other:
• MRI
3 tesla (T) MRI to provide higher resolution and quality brain images.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Boutet A, Loh A, Chow CT, Taha A, Elias GJB, Neudorfer C, Germann J, Paff M, Zrinzo L, Fasano A, Kalia SK, Steele CJ, Mikulis D, Kucharczyk W, Lozano AM. A literature review of magnetic resonance imaging sequence advancements in visualizing functional neurosurgery targets. J Neurosurg. 2021 Mar 26;135(5):1445-1458. doi: 10.3171/2020.8.JNS201125. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative image quality metrics	Two quantitative image quality metrics commonly used are contrast-to-noise ratio (CNR) and signal-to-noise ratio (SNR). CNR (i.e., the ratio of the contrast between the signal in a given region and the background) is a measure of the contrast between the tissue of interest and the neighboring tissue. Similarly, SNR is a measure of the average image signal in a given region to the neighboring tissue or the noise around the region of interest.	= 1 week before surgery
Primary	Qualitative image quality metrics	Qualitative image quality metrics will assess the image quality and clinical acceptability of each scan in a randomized order. Each scan will be scored using a 5-point Likert scale by expert raters. An overall average score will be calculated for each MRI sequence.	= 1 week before surgery

External Links

•   A literature review of magnetic resonance imaging sequence advancements in visualizing functional neurosurgery targets