Visualization of Neural Targets With 3T MRI

NCT ID: NCT05175417

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-29

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuro-Degenerative Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

MRI

Intervention Type OTHER

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

Control

Healthy control volunteers.

MRI

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MRI

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Andres M. Lozano

University Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andres M Lozano, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto, ON

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Tasnuva T Hoque, BSc

Role: CONTACT

4166035800 ext. 2797

Monika Singh

Role: CONTACT

4166035800 ext. 2797

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Clement T Chow, MSc

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 33770759 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://pubmed.ncbi.nlm.nih.gov/33770759/

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

21-6105

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

31P-MRS and Huntington Disease
NCT01359774 COMPLETED NA