Accelerated Neuromodulation of Anterior Cingulate Cortex for Depression

NCT ID: NCT07212465

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-21
• Study Completion Date: 2027-02-15

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.

Detailed Description

This study will investigate the effects of an accelerated intermittent theta burst protocol (a-iTBS) using the H7 deep Transcranial Magnetic Stimulation (dTMS) coil to target the anterior cingulate cortex (ACC) in older adults (aged 60-85) with Major Depressive Disorder (MDD). Twenty-four older adults with treatment-resistant MDD will participate in a single site, double-blind, randomized sham-controlled trial using an accelerated schedule of multiple dTMS sessions per day for 5 consecutive days. The primary goal of the study is to establish the feasibility of an accelerated aiTBS protocol of the ACC in older adults with treatment resistant depression, and to obtain preliminary evidence of treatment efficacy.

Conditions

Major Depressive Disorder (MDD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Sham Brainsway H1-Coil Deep TMS System

Intervention Type: DEVICE

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.

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

Group Type: EXPERIMENTAL

Active Brainsway H7-Coil Deep TMS System

Intervention Type: DEVICE

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.

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rotman Research Institute at Baycrest

OTHER

Sponsor Role: lead

Responsible Party

Linda Mah, MD

Clinician Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Linda Mah, MD

Role: PRINCIPAL_INVESTIGATOR

Baycrest Rotman Research Institute

Locations

Rotman Research Institute at Baycrest

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Amanda Chao, MPH

Role: CONTACT

preventad@research.baycrest.org

416-785-2500 ext. 3434

Linda Mah, MD

Role: CONTACT

preventad@research.baycrest.org

416-785-2500 ext. 3434

Facility Contacts

Linda Mah, MD

Role: primary

preventad@research.baycrest.org

416-785-2500 ext. 3434

Other Identifiers

25-03

Identifier Type: -

Identifier Source: org_study_id