Visualization of Neural Targets With 3T MRI

NCT05175417 | Recruiting

• 1 other identifier: 21-6105
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuro-Degenerative Disease

Keywords

MRI sequence parameters

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Case

Patients being considered for functional neurosurgical procedures, such as deep brain stimulation (DBS), radiofrequency ablation (RFA), gamma knife radiosurgery (GKR), or magnetic resonance-guided focused ultrasound (MRgFUS).

Other: MRI

Control

Healthy control volunteers.

Other: MRI

Interventions

MRI OTHER

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

Case; Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients indicated for deep brain stimulation (DBS), radiofrequency ablation (RFA), gamma knife radiosurgery (GKR), or magnetic resonance-guided focused ultrasound (MRgFUS).

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Related 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. Print 2021 Nov 1.

  PMID: 33770759 BACKGROUND

Related Links

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

Study Officials

• Andres M Lozano, MD/PhD

  University Health Network, Toronto, ON

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tasnuva T Hoque, BSc

CONTACT

4166035800; tasnuva.hoque@uhnresearch.ca

Monika Singh

CONTACT

4166035800; Monika.Singh@uhn.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Professor

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 3, 2022
• Study Start: January 29, 2022
• Primary Completion: August 29, 2024
• Study Completion: December 31, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)