RecruitingPhase 1NCT06719427

qEEG Brain Signature of Depression & Neuromodulation-induced Recovery

Quantitative Electroencephalography to Longitudinally Assess the Functional Brain Signature of Treatment-resistant Depression and Recovery With Therapeutic Neuromodulation


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

100 participants

Start Date

Jan 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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.
  • Able to provide informed consent and comply with the study protocol.

Exclusion Criteria5

  • 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
  • Pregnant

Interventions

DEVICETranscranial Magnetic Stimulation

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.


Locations(2)

Sunnybrook Health Sciences Centre

North York, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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NCT06719427


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