Recruiting

Accelerated Neuromodulation of Anterior Cingulate Cortex for Depression

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.

ClinicalTrials.gov IDNCT07212465

PhaseNA

Enrollment24

SponsorRotman Research Institute at Baycrest

Age60 Years – 85 Years

SexALL

I'm interested View official listing

Conditions studied

Major Depressive Disorder (MDD)

About this study

Interventions

Device: 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.
Device: 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 outcomes

Percentage of scheduled treatment sessions that are attended by study participants (6 weeks)
Participant-reported comfort and feasibility based on the frequency and type of adverse events as measured using the Adverse Events Questionnaire (AEQ) (6 weeks)
The number of participants who have prematurely withdraw and reasons for withdrawal (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. (1 week)

Eligibility information

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 locations

Rotman Research Institute at Baycrest, Toronto, Ontario M6A 2E1 Canada

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-13.