MRI Guided Closed-loop TMS-EEG
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSunnybrook Health Sciences Centre
About this trial
The goal of this interventional study is to develop an individualized approach using transcranial magnetic stimulation (TMS) in a high-precision manner. This approach will use TMS to modulate brain activity at multiple locations simultaneously. Functional magnetic resonance imaging (fMRI) and electroencephalograph (EEG) will record the responses and guide the stimulation. Specifically, the placement and orientation of TMS coils will be tailored to stimulate the targeted functional brain areas informed by fMRI. To maximize the interventional effect, stimulation pulses will be delivered based on EEG oscillations.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ages between 18 and 65 years;
Healthy with no history of neurological impairment;
Normal or correct-to-normal vision.
Age 50-80 years;
Disqualifiers
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);
Trial design
Design model
Single group
Treatments tested in this trial
TMS
DeviceThe target locations of TMS will be cortical regions defined by either anatomical landmarks or functional regions derived from the individual's functional and structural MRI for Aim 1. TMS target locations for Aim 2 and 3 are determined by Aim 1's results. These TMS target regions will be guided by a navigation system. TMS will be parametrically varied with combinations of pulse strength and frequencies based on experimental conditions. TMS strength will be referred to the resting motor threshold (rMT), which will be determined independently for each participant. TMS pulses will be delivered at fixed time instants for Aim 2 and at time instants based on the phase of oscillatory neural activity for Aim 3.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Experimental_Aim1: Healthy VolunteersExperimental treatment 1 intervention
Group B: Experimental_Aim2: Amnestic Mild Cognitive ImpairmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Functional connectivity measured by fMRI
Functional connectivity during resting state and psychological tasks
Time frame
At baseline and immediately after treatment2
Response accuracy to psychological tasks
accuracy, or rate of conditioned responses
Time frame
At baseline and immediately after treatment3
Reaction times
Time frame
At baseline and immediately after treatmentSecondary outcomes
1
EEG functional connectivity
Pearson correlation coefficients (r) between electrodes
Time frame
At baseline and immediately after treatmentSponsors and contacts
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Source ClinicalTrials.gov