MRI Guided Closed-loop TMS-EEG

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Sep 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to use a technique called transcranial magnetic stimulation (TMS) to help people with mild cognitive impairment (MCI), particularly those who have memory issues but still can function independently. The goal is to personalize the treatment by using advanced brain imaging techniques to ensure that the TMS is applied precisely where it's needed in the brain. By combining TMS with other methods that measure brain activity, the researchers hope to enhance the effectiveness of the treatment.

To participate in this study, healthy volunteers aged 18 to 65 or patients aged 50 to 80 with amnestic MCI may be eligible, provided they have certain cognitive test scores and meet other specific criteria. Participants can expect to undergo brain scans and receive TMS treatment in a comfortable setting, while being monitored closely. It’s important to note that individuals with certain medical conditions or those who may feel anxious in small spaces, like an MRI machine, may not qualify for this study. This trial aims to create a more targeted approach to brain stimulation that could lead to better outcomes for individuals experiencing memory challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria for Healthy participants:
• • Ages between 18 and 65 years;
• • Healthy with no history of neurological impairment;
• • Normal or correct-to-normal vision.
• Inclusion Criteria for aMCI patients:
• • Age 50-80 years;
• • MCI clinical criteria: (a) self- or informant-reported cognitive complaint; (b) preserved independence in functional abilities; and (c) absence of dementia;
• • Objective cognitive impairment supported by the following measures of general cognitive function: (a) Mini-Mental State Exam (MMSE) 24-27 (inclusive); (b) Montreal Cognitive Assessment (MoCA) 18-26 (inclusive); or (c) Clinical Dementia Rating Scale score of 0.5;
• • Normal or correct-to-normal vision.
• Exclusion Criteria for all participants:
• • Women who are pregnant or breastfeeding;
• • History of seizure (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain tumor, brain surgery, head injury, known structural brain lesion;
• • Have metal in the eye or skull area, brain stimulator, surgical metal, clips in the brain, cochlear implants, mental fragments in the eye, as these make TMS unsafe;
• • Have non-MRI compatible metal in the body, for example metallic (forromagnetic) implants (e.g., cardiac pacemaker, aneurysm clip);
• • Subjects who are uncomfortable in small closed spaces (have claustrophobia), unable to lie comfortably supine for up to 1 hour, and would feel uncomfortable in the MRI machine;
• • Participation in any other study involving non-invasive brain stimulation less than two weeks ago;
• • Abnormal findings on neurological examination that we will perform.