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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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06719427
Enrollment
100
Registered
2024-12-05
Start date
2025-01-06
Completion date
2028-01-01
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Diorder

Keywords

Transcranial Magnetic Stimulation, Treatment-resistant Depression, Mood Disorders, Mental Disorders, Depressive Disorder, Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, qEEG, resting-state connectivity, neuromodulation, brain networks

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.

Detailed description

The objective of this study is to evaluate functional brain activity measures that correlate with clinically assessed mood symptoms and their changes before, during, and after repetitive transcranial magnetic stimulation (rTMS) treatment for a major depressive episode. A secondary aim is to explore the relationship between pre- and post-treatment functional brain changes and depression outcomes, including changes in depression scores, response rates, and remission status. The dorsolateral prefrontal cortex (DLPFC), a brain region involved in mood regulation, shows altered activity in depression and will be targeted in this study. All patients in this study will undergo an accelerated rTMS protocol over the course of five days, using the pre-treatment imaging to localize the brain region (i.e. DLPFC) targeted by the TMS coil. In addition to rTMS, the investigators will administer questionnaires to evaluate mood and function at multiple time points: before, during, and after treatment. Patients will also undergo dry quantitative EEG (qEEG), which records brain electrical activity to see how these networks are altered in depression and rescued by rTMS. Participants will also undergo dry quantitative EEG (qEEG) recordings, a method that measures brain electrical activity, to investigate how brain networks are disrupted in depression and how they are modulated by rTMS. Participants who respond to rTMS will be monitored for recurrence of depressive symptoms during follow-up visits. If depressive symptoms worsen, maintenance treatment will be administered. Two maintenance TMS protocols will be compared in this study: 1) a gradually tapering protocol involving once-daily treatments delivered weekly for one month, followed by a gradual taper to one treatment every two weeks for two months, 2) a cluster protocol involving five treatments delivered over two consecutive weekdays (e.g., two treatments on Day 1 and three treatments on Day 2, or vice versa). This research aims to deepen our understanding of the mechanisms by which rTMS modulates brain activity, improve our ability to predict treatment response, and determine the most effective maintenance treatment protocol for sustained symptom relief.

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.

Sponsors

Mitacs
CollaboratorINDUSTRY
iMediSync
CollaboratorUNKNOWN
Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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. * Patients will not be excluded solely based on communication (i.e., non-English speaking) unless they have

Exclusion criteria

that is the cause of the communication difficulties.

Design outcomes

Primary

MeasureTime frameDescription
Change in Depression Score on the Montgomery-Asberg Depression Rating Scale (MADRS)2 yearsChange in depression symptomatology as assessed by the clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) (range 0-60). Higher scores indicate worse outcomes

Secondary

MeasureTime frameDescription
Changes in functional connectivity2 yearsChange between baseline measured qEEG resting-state connectivity and post TMS qEEG connectivity
Relapse rates measured on the Montgomery-Asberg Depression Rating Scale2 yearsExamine relapse rates on the depression rating scale (0-60) over 12 months, following successful response to neuromodulation with qEEG

Countries

Canada

Contacts

Primary ContactSean M Nestor, M.D.
sean.nestor@utoronto.ca416-347-0257
Backup ContactChris B Pople, MSc
chris.pople@mail.utoronto.ca416-474-5512

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026