Recruiting
Phase 1

Depression & Neuromodulation

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT06719427

Conditions

Major Depressive Diorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcranial Magnetic Stimulation

Study Details

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.

Conditions

Major Depressive Diorder

Study ID

NCT06719427

Start date

Jan 6, 2025

Status verified date

Nov, 2024

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Cluster Maintenance TMS

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)

active comparator: Gradual Tapering TMS

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

Interventions

Transcranial 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.

Primary outcome measure

  • Change in Depression Score on the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Sean M Nestor, M.D.

416-347-0257sean.nestor@utoronto.ca

Chris B Pople, MSc

416-474-5512chris.pople@mail.utoronto.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Dara Silver

6474044181ejsilver@rogers.com

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Mar 3, 2025

Last verified

Nov, 2024

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2025-03-03.