Major Depressive DiorderPhase 1NCT06719427
qEEG Brain Signature of Depression & Neuromodulation-induced Recovery
A Phase 1 study testing Transcranial Magnetic Stimulation in people with Major Depressive Diorder, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Major Depressive Diorder
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- 6 Jan 2025to 1 Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Not yet recruiting
Sunnybrook Health Sciences Centre
North York, Ontario, M4N 3M5
Sean M Nestor, M.D., 416-347-0257, sean.nestor@utoronto.ca
Chris B Pople, MSc, 416-474-5512, chris.pople@mail.utoronto.ca
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Dara Silver, 6474044181, ejsilver@rogers.com
About this study
Official title: Quantitative Electroencephalography to Longitudinally Assess the Functional Brain Signature of Treatment-resistant Depression and Recovery With Therapeutic Neuromodulation
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.
Read the 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.
- Conditions
- Major Depressive Diorder
- Being tested
- Transcranial Magnetic Stimulation
- 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
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Mood Disorders, Mental Disorders, Depressive Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Also called rTMS, iTBS
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.
| Study group | Role | What they receive |
|---|---|---|
| Cluster Maintenance TMS | Active comparator | Participants 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) Receives: Device: Transcranial Magnetic Stimulation |
| Gradual Tapering TMS | Active comparator | Participants 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 Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (2)
Changes in functional connectivity
Change between baseline measured qEEG resting-state connectivity and post TMS qEEG connectivity
Measured: 2 years
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start6 Jan 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DiorderStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Mitacs, iMediSync
- Responsible party
- Principal investigator, Dr. Sean Michael Nestor, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719427
- Sponsor's protocol ID
- 6178
- Other IDs
- IT41597
- Status last verified
- Nov 2024
- First submitted
- 27 Nov 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Electroencephalography to Longitudinally Assess the Functional Brain Signature of Treatment-resistant Depression and Recovery With Therapeutic Neuromodulation
- ClinicalTrials.gov ID
- NCT06719427
- Acronym / sponsor ID
- 6178
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Mitacs, iMediSync
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cluster Maintenance TMS | Active comparator | Device: Transcranial Magnetic StimulationParticipants 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 comparator | Device: Transcranial Magnetic StimulationParticipants 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic StimulationAlso: rTMS, iTBSrTMS 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. | Device | Cluster Maintenance TMS, Gradual Tapering TMS |
Primary outcome
Change in Depression Score on the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 2 years
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 secondary outcomes
Changes in functional connectivity
Time frame: 2 years
Relapse rates measured on the Montgomery-Asberg Depression Rating Scale
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transcranial Magnetic Stimulation in people with Major Depressive Diorder, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sean M Nestor, M.D. (416-347-0257, sean.nestor@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression Score on the Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.