Recruiting

dTMS

Sponsor:

Rotman Research Institute at Baycrest

Code:

NCT07212465

Conditions

Major Depressive Disorder (MDD)

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

Active Brainsway H7-Coil Deep TMS System

Sham Brainsway H1-Coil Deep TMS System

Study Details

Brief summary:

The goal of this clinical trial is to test whether an accelerated deep Transcranial Magnetic Stimulation (dTMS) protocol can reduce depressive symptoms in older adults (ages 60-85) with Major Depressive Disorder (MDD) who have not tolerated or responded to antidepressant medications. The study will evaluate whether accelerated dTMS administered over 5 consecutive days is safe and well-tolerated in this population, and whether it produces greater reductions in depressive symptoms compared to placebo stimulation.

Conditions

Major Depressive Disorder (MDD)

Study ID

NCT07212465

Start date

Jul 21, 2025

Status verified date

Sep, 2025

Completion date

Feb 15, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • are between 60- 85 years old (on the day of randomization)
  • have been diagnosed with DSM5 Major Depressive Disorder, with the current episode longer than 4 weeks but less than 5 years
  • did not respond to/did not tolerate, or failed to achieve remission with at least one antidepressant trial of 8 week minimum duration
  • are willing to provide informed consent
  • are able to follow the treatment schedule
  • are stable on medications for 2 months and are not expected to change medication during the entire study period (if they are taking medications)
  • have a satisfactory safety screening questionnaire for TMS

Exclusion Criteria:

  • have a metal plate in your head (such as an ear implant, implanted brain stimulators, aneurysm clips). Dental devices and implants that are non-magnetic are safe
  • have known increased pressure or a history of increased pressure in their brain, which may increase their risk for having seizures
  • have a cardiac pacemaker
  • have an implanted medication pump
  • have a central venous line
  • have a history of any psychotic disorder, bipolar disorder, eating disorder, obsessive compulsive disorder, post-traumatic stress disorder, or dementia
  • have a history of substance abuse in the last 6 months
  • have a history of stroke or other brain lesions
  • have a personal history of epilepsy
  • have a family history of epilepsy
  • are a pregnant or breast-feeding woman
  • have a history of abnormal MRI of the brain
  • have untreated hypo- or hyper-thyroidism
  • have unstable medical condition(s)
  • have any other known contraindications to TMS
  • are on unstable doses of any psychotropic medication such as - antidepressants, antipsychotic, mood stabilizers or memory enhancing medications
  • require daily doses of benzodiazepines or hypnotics within two weeks of randomization

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: 20-40 sessions of sham stimulation

Participants will receive sham intervention if randomized into sham condition. The sham intervention consists of treatment with similar technical parameters which induce scalp sensations but do not penetrate into the brain.

experimental: 20-40 sessions of iTBS dTMS

Participants will receive dTMS if randomized into the active condition. The motor threshold (MT) will be measured by delivering single stimulations to the motor cortex with gradually increased intensity. The stimulation protocol consists of 6-8 dTMS sessions of intermittent theta burst stimulation delivered at an intensity of 80-90% of resting MT each day for five consecutive days

Interventions

Active Brainsway H7-Coil Deep TMS System

Deep Transcranial Magnetic Stimulation (dTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The H-coil is a novel dTMS coil designed to allow deeper brain stimulation without a significant increase of electric fields induced in superficial cortical regions. dTMS will be administered 6-8 times a day for 5 consecutive days.

Sham Brainsway H1-Coil Deep TMS System

In addition to the active H7-coil, a sham coil is included in the H1-coil helmet. The sham treatment will be administered 6-8 times a day for 5 consecutive days.

Primary outcome measure

  • Percentage of scheduled treatment sessions that are attended by study participants [ Time Frame: 6 weeks ]
  • Participant-reported comfort and feasibility based on the frequency and type of adverse events as measured using the Adverse Events Questionnaire (AEQ) [ Time Frame: 6 weeks ]
  • The number of participants who have prematurely withdraw and reasons for withdrawal [ Time Frame: 6 weeks ]
  • The change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) scores following the final treatment on day 5 (i.e., after 5 days of H7-coil a-iTBS) in the treatment group compared to the sham group. [ Time Frame: 1 week ]

Central Contacts and Locations

Central contacts

Amanda Chao, MPH

416-785-2500preventad@research.baycrest.org

Linda Mah, MD

416-785-2500preventad@research.baycrest.org

Locations

Rotman Research Institute at Baycrest

Recruiting

Toronto, Ontario, Canada, M6A 2E1

Contacts

Linda Mah, MD

416-785-2500preventad@research.baycrest.org

More Information

Sponsor

Rotman Research Institute at Baycrest

Last update posted

Oct 28, 2025

Last verified

Sep, 2025

Keywords

  • Transcranial Magnetic Stimulation (TMS)
  • Treatment Resistant Depression
  • Intermittent Theta Burst Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rotman Research Institute at Baycrest on 2025-10-28.