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
2 other identifiers
interventional
100
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2025
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2024
CompletedFirst Posted
Study publicly available on registry
December 5, 2024
CompletedStudy Start
First participant enrolled
January 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
March 3, 2025
November 1, 2024
2 years
November 27, 2024
February 26, 2025
Conditions
Keywords
Outcome Measures
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
2 years
Secondary Outcomes (2)
Changes in functional connectivity
2 years
Relapse rates measured on the Montgomery-Asberg Depression Rating Scale
2 years
Study Arms (2)
Cluster Maintenance TMS
ACTIVE COMPARATORParticipants will receive a cluster of treatments consisting of 5 treatments over two consecutive week days (either 2 treatments on day 1 followed by 3 treatments day 2 or vice-versa, based on scheduling)
Gradual Tapering TMS
ACTIVE COMPARATORParticipants will receive a once daily treatment protocol delivered once weekly for 1 month, and gradually tapering the frequency of treatment to 1 treatment every 2 weeks for 2 months
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sunnybrook Health Sciences Centrelead
- Mitacscollaborator
- iMediSynccollaborator
Study Sites (2)
Sunnybrook Health Sciences Centre
North York, Ontario, M4N 3M5, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 27, 2024
First Posted
December 5, 2024
Study Start
January 6, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
March 3, 2025
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share