Recruiting

MRI

Sponsor:

University Health Network, Toronto

Code:

NCT05175417

Conditions

Neuro-Degenerative Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

MRI

Study Details

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

Study ID

NCT05175417

Start date

Jan 29, 2022

Status verified date

May, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Aug 29, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: 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).

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

Control

Healthy control volunteers.

Interventions

MRI

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

Primary outcome measure

  • Quantitative image quality metrics [ Time Frame: ≤ 1 week before surgery ]
  • Qualitative image quality metrics [ Time Frame: ≤ 1 week before surgery ]

Central Contacts and Locations

Central contacts

Tasnuva T Hoque, BSc

4166035800tasnuva.hoque@uhnresearch.ca

Monika Singh

4166035800Monika.Singh@uhn.ca

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 8, 2024

Last verified

May, 2024

Keywords

  • MRI sequence parameters

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2024-05-08.