Health TrialsbyHealthPanel

qEEG Brain Signature of Depression & Neuromodulation-induced Recovery

ConditionMajor Depressive Diorder
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSunnybrook Health Sciences Centre

About this trial

This study aims to explore how repetitive transcranial magnetic stimulation (rTMS), a treatment for depression, affects brain function. Depression disrupts the brain's complex network or regions that regulate cognition, emotion, and behavior. rTMS targets these disruptions to restore network function. To measure these effects, researchers will use dry quantitative EEG (qEEG), a new technology that records brain electrical activity quickly (15 minutes compared to 1 hour for traditional EEG) without the need for gel or lengthy electrode setups. This study will evaluate a novel qEEG activity developed by iMediSync (Republic of South Korea) in patients treated with neuromodulation for depression before, during, and up to 12 months after treatment to see if changes in brain activity to identify patterns associated with symptomatic improvement and relapse risk. Findings could help personalize depression treatments by predicting patient outcomes and optimizing care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

A diagnosis of Depression based on Diagnostic and Statistical Manual (DSM) 5.0 criteria.

Receiving a neuromodulation (rTMS) treatment for depression at the HCN

Physically healthy

Age 18-80, inclusive.

Disqualifiers

Moderate substance use disorder or greater severity based on DSM 5.0 criteria and confirmed by a study MD on clinical assessment.

Mild and major comorbid medical conditions (as determined by investigators - e.g., neurological diseases, uncontrolled hypertension or diabetes, malignancy)

A major comorbid psychiatric disorder (as determined by investigators - e.g., schizophrenia or bipolar disorder) and/or psychosis at the time of study enrollment.

History of seizure disorder

Trial design

Design model

Single group

Treatments tested in this trial

  • Transcranial Magnetic Stimulation

    Device

    rTMS is a non-invasive brain stimulation that uses magnetic fields to stimulate specific areas of the brain. It is commonly used for the treatment of neurological and psychiatric disorders, such as major depressive disorder (MDD), anxiety, and sometimes ALS.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Cluster Maintenance TMSActive comparator 1 intervention
Group B: Gradual Tapering TMSActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Depression Score on the Montgomery-Asberg Depression Rating Scale (MADRS)

Change in depression symptomatology as assessed by the clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) (range 0-60). Higher scores indicate worse outcomes

Time frame
2 years

Secondary outcomes

1

Changes in functional connectivity

Change between baseline measured qEEG resting-state connectivity and post TMS qEEG connectivity

Time frame
2 years
2

Relapse rates measured on the Montgomery-Asberg Depression Rating Scale

Examine relapse rates on the depression rating scale (0-60) over 12 months, following successful response to neuromodulation with qEEG

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sunnybrook Health Sciences Centre

Lead sponsor

Mitacs

Collaborator

iMediSync

Collaborator

Source ClinicalTrials.gov
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