Major Depressive Disorder (MDD)NACC-DNCT07212465
Accelerated Neuromodulation of Anterior Cingulate Cortex for Depression
A study testing Active Brainsway H7-Coil Deep TMS System in people with Major Depressive Disorder (MDD), run by Rotman Research Institute at Baycrest at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Active Brainsway H7-Coil Deep TMS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jul 2025to 15 Feb 2027
- Phase
- Interventional
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Rotman Research Institute at Baycrest
Toronto, Ontario, M6A 2E1
Linda Mah, MD, 416-785-2500 ext. 3434, preventad@research.baycrest.org
About this study
Official title: Feasibility, Tolerability, and Preliminary Efficacy for Non-Invasive Neuromodulation of the Anterior Cingulate Cortex for Depression (NACC-D) in Older Adults Using Deep Transcranial Magnetic Stimulation With an Accelerated Intermittent Theta Burst Protocol
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.
Read the 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)
- Being tested
- Active Brainsway H7-Coil Deep TMS System, Sham Brainsway H1-Coil Deep TMS System
- Keywords
- Transcranial Magnetic Stimulation (TMS), Treatment Resistant Depression, Intermittent Theta Burst Stimulation
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Brainsway H7-Coil Deep TMS SystemDevice
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 SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 20-40 sessions of sham stimulation | Sham comparator | 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. Receives: Device: Sham Brainsway H1-Coil Deep TMS System |
| 20-40 sessions of iTBS dTMS | Experimental | 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 Receives: Device: Active Brainsway H7-Coil Deep TMS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of scheduled treatment sessions that are attended by study participants
Measured: 6 weeks
Participant-reported comfort and feasibility based on the frequency and type of adverse events as measured using the Adverse Events Questionnaire (AEQ)
Severity of symptoms is rated from 1 to 4, with 1 being absent and 4 being severe. Whether symptoms are perceived to be relatedTMS treatment are rated from 1 to 5, with 1 being no and 5 being definitely.
Measured: 6 weeks
The number of participants who have prematurely withdraw and reasons for withdrawal
Measured: 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.
An effect size (Cohen's d) of 0.5 will be considered a minimally important effective size. The MADRS ranges from 0-60, with a greater score indicating greater depressive symptoms.
Measured: 1 week
Secondary outcomes (8)
Response rates compared between treatment groups following 5 days of treatment, where the response rate refers to the percentage of patients who responded to a-ITBS treatment and response is defined as a ≥50% reduction in MADRS score from baseline
Response rates will be compared from baseline to after 5 day treatment and at 1 month follow-up. MADRS scores range from 0-60, with a greater score indicating greater severity of depressive symptoms.
Measured: 6 weeks
Remission rates compared between treatment groups following 5 days of treatment, where the remission rate is defined as MADRS score <10
MADRS scores will be compared between baseline, after 5 days of treatment and at 1-month follow-up. The MADRS ranges from 0-60, with a greater score indicating greater depressive symptoms
Measured: 6 weeks
The change in baseline slow wave and resting state activity as measured with electroencephalography (EEG) following 5 days of treatment and at 1-month follow-up
Measured: 6 weeks
The change in functional connectivity within the default mode and central autonomic networks on Magnetic Resonance Imaging (MRI)
Measured: 1 week
The change in slow wave activity in the posterior default mode network (posterior cingulate cortex) as measured with MEG
Measured: 1 week
The change in baseline cognitive tests following 5 days of treatment and at 1-month follow-up (cognitive domains tested include executive function and memory),
Baseline cognitive tests will be measured using a neuropsychological test battery.
Measured: 6 weeks
The change in baseline resting state heart rate variability (HRV) following a single TMS session and after 5 days of treatment
Measured: 1 week
The change in baseline emotional processing as measured with an Affective Simon task following a single TMS session, after 5 days of treatment and at 1-month follow-up
The Affective Simon task will measure the number of correct responses to stimuli in the task.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start21 Jul 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rotman Research Institute at Baycrest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Mah, MD, Rotman Research Institute at Baycrest
- Investigators
- Linda Mah, MD, Principal investigator, Baycrest Rotman Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212465
- Sponsor's protocol ID
- 25-03
- Acronym
- NACC-D
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 28 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Tolerability, and Preliminary Efficacy for Non-Invasive Neuromodulation of the Anterior Cingulate Cortex for Depression (NACC-D) in Older Adults Using Deep Transcranial Magnetic Stimulation With an Accelerated Intermittent Theta Burst Protocol
- ClinicalTrials.gov ID
- NCT07212465
- Acronym / sponsor ID
- NACC-D / 25-03
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Transcranial Magnetic Stimulation (TMS), Treatment Resistant Depression, Intermittent Theta Burst Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Rotman Research Institute at BaycrestUniversity, hospital or other
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 8 Oct 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20-40 sessions of sham stimulation | Sham comparator | Device: Sham Brainsway H1-Coil Deep TMS SystemParticipants 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. |
| 20-40 sessions of iTBS dTMS | Experimental | Device: Active Brainsway H7-Coil Deep TMS SystemParticipants 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 |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| Active Brainsway H7-Coil Deep TMS SystemDeep 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 | 20-40 sessions of iTBS dTMS |
| Sham Brainsway H1-Coil Deep TMS SystemIn 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. | Device | 20-40 sessions of sham stimulation |
Primary outcome
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
Severity of symptoms is rated from 1 to 4, with 1 being absent and 4 being severe. Whether symptoms are perceived to be relatedTMS treatment are rated from 1 to 5, with 1 being no and 5 being definitely.
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
An effect size (Cohen's d) of 0.5 will be considered a minimally important effective size. The MADRS ranges from 0-60, with a greater score indicating greater depressive symptoms.
8 secondary outcomes
Response rates compared between treatment groups following 5 days of treatment, where the response rate refers to the percentage of patients who responded to a-ITBS treatment and response is defined as a ≥50% reduction in MADRS score from baseline
Time frame: 6 weeks
Remission rates compared between treatment groups following 5 days of treatment, where the remission rate is defined as MADRS score <10
Time frame: 6 weeks
The change in baseline slow wave and resting state activity as measured with electroencephalography (EEG) following 5 days of treatment and at 1-month follow-up
Time frame: 6 weeks
The change in functional connectivity within the default mode and central autonomic networks on Magnetic Resonance Imaging (MRI)
Time frame: 1 week
The change in slow wave activity in the posterior default mode network (posterior cingulate cortex) as measured with MEG
Time frame: 1 week
The change in baseline cognitive tests following 5 days of treatment and at 1-month follow-up (cognitive domains tested include executive function and memory),
Time frame: 6 weeks
The change in baseline resting state heart rate variability (HRV) following a single TMS session and after 5 days of treatment
Time frame: 1 week
The change in baseline emotional processing as measured with an Affective Simon task following a single TMS session, after 5 days of treatment and at 1-month follow-up
Time frame: 6 weeks
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 28 Oct 2025.
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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.
Linda Mah, MD principal investigator
Baycrest Rotman Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Brainsway H7-Coil Deep TMS System in people with Major Depressive Disorder (MDD), run by Rotman Research Institute at Baycrest at 1 site 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 7 inclusion and 17 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 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Amanda Chao, MPH (416-785-2500 ext. 3434, preventad@research.baycrest.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of scheduled treatment sessions that are attended by study participants (time frame: 6 weeks). The study lists 4 primary outcomes in all. 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 28 Oct 2025.