Neuro-Degenerative DiseaseNCT05175417
Visualization of Neural Targets With 3T MRI
An observational study of Neuro-Degenerative Disease, run by University Health Network, Toronto at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuro-Degenerative Disease
- What is being tested?
- MRI
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jan 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients indicated for deep brain stimulation (DBS), radiofrequency ablation (RFA), gamma knife radiosurgery (GKR), or magnetic resonance-guided focused ultrasound (MRgFUS).
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Clement T Chow, MSc
About this study
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.
Read the detailed 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.
- Conditions
- Neuro-Degenerative Disease
- Being tested
- MRI
- Keywords
- MRI sequence parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
3 tesla (T) MRI to provide higher resolution and quality brain images.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: MRI | |
| Control | Healthy control volunteers. Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ≤ 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.
Measured: ≤ 1 week before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start29 Jan 2022
- Primary completion29 Aug 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuro-Degenerative DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres M. Lozano, University Health Network, Toronto
- Investigators
- Andres M Lozano, MD/PhD, Principal investigator, University Health Network, Toronto, ON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175417
- Sponsor's protocol ID
- 21-6105
- Status last verified
- May 2024
- First submitted
- 14 Dec 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33770759
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualization of Neural Targets With 3T MRI
- ClinicalTrials.gov ID
- NCT05175417
- Acronym / sponsor ID
- 21-6105
- Conditions
- Neuro-Degenerative Disease
- Keywords
- MRI sequence parameters
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 29 Jan 2022 (actual)
- Primary completion
- 29 Aug 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: MRIPatients 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 | – | Other: MRIHealthy control volunteers. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients indicated for deep brain stimulation (DBS), radiofrequency ablation (RFA), gamma knife radiosurgery (GKR), or magnetic resonance-guided focused ultrasound (MRgFUS).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI3 tesla (T) MRI to provide higher resolution and quality brain images. | Other | Case, Control |
Primary outcome
Quantitative image quality metrics
Time frame: ≤ 1 week before surgery
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.
Qualitative image quality metrics
Time frame: ≤ 1 week before surgery
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 33770759Boutet 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.
- A literature review of magnetic resonance imaging sequence advancements in visualizing functional neurosurgery targetsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andres M Lozano, MD/PhD principal investigator
University Health Network, Toronto, ON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuro-Degenerative Disease, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tasnuva T Hoque, BSc (4166035800 ext. 2797, tasnuva.hoque@uhnresearch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative image quality metrics (time frame: ≤ 1 week before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05175417, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.