Major Depressive DisorderNCT03665831
Deep TMS for Comorbid Depression and Cognitive Impairment in Older Adults
A study testing Brainsway H1-Coil Deep TMS System in people with Major Depressive Disorder and Alzheimer Disease, run by Rotman Research Institute at Baycrest at 1 site in Canada.
Trial summary
In this study, the investigators will be examining the effects of the deep repetitive transcranial magnetic stimulation (rTMS) using the H1 coil in patients over the age of 60 diagnosed with mild to early-moderate Alzheimer's disease (AD) or mild cognitive impairment (MCI) and comorbid Major Depressive Disorder (MDD)… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Major Depressive Disorder, Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- Brainsway H1-Coil Deep TMS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 23 Oct 2018to 15 Sep 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meet DSM 5 criteria for Major or Mild Neurocognitive Disorder due to Alzheimer's disease with Clinical Dementia Rating Scale (CDR) score of at least 0.5
- 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 or did not tolerate antidepressant treatment
- 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
- have an informant/study partner who is able to complete study questionnaires regarding the participant
Who cannot join
- have a metal plate in their head, except in the mouth (such as an ear implant, implanted brain stimulators, aneurysm clips)
- 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 significant heart disease or history of stroke
Show all 18Show fewer
- Modified Hachinski Score (MHIS) > 3 (to exclude those with significant vascular component to memory loss)
- have a history of any psychotic disorder, bipolar disorder, eating disorder, obsessive compulsive disorder, post-traumatic stress disorder, or dementia other than AD
- 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
- are taking psychotropic medications including antidepressant medications, antipsychotics or mood stabilizing medications due to increased risk of seizure
- are taking memantine
- have a history of abnormal MRI of the brain
- have significant hearing loss requiring use of hearing aids
- have untreated hypo- or hyper-thyroidism
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, MHS, FRCPC, 416-785-2500 ext. 3434, preventad@research.baycrest.org
About this study
Official title: Treatment of Comorbid Depression and Cognitive Impairment in Older Adults With Neurocognitive Disorders Using Deep Transcranial Magnetic Stimulation (dTMS)
In this study, the investigators will be examining the effects of the deep repetitive transcranial magnetic stimulation (rTMS) using the H1 coil in patients over the age of 60 diagnosed with mild to early-moderate Alzheimer's disease (AD) or mild cognitive impairment (MCI) and comorbid Major Depressive Disorder (MDD) who have been unable to tolerate or failed to respond to antidepressant medications. The coil was designed to stimulate deeper regions of the left dorsolateral prefrontal cortex (DLPFC). Based on prior research, the investigators propose that active stimulation with the H1 coil for 4 weeks may result in significant remission rates and will be tolerable and safe.
Read the detailed description
This study is an open-label trial to evaluate the safety and efficacy of H1-coil dTMS in treating depression in MCI and mild AD patients over 60 years of age who have not tolerated or failed to respond to antidepressant medications. 28 patients will be assigned to receive 4 consecutive weeks of daily active dTMS treatment. The long-term effects of treatment on emotional cognitive measures will be assessed at a 4-week follow-up visit (8 weeks from baseline). Symptom change and remission criteria will be assessed using the Montogmery-Asberg Depression Rating Scale (MADRS). Cognition will be assessed using a validated neuropsychological battery.
We will also offer patients to receive 4 weeks of treatment using theta-burst TMS, which is a milder version of TMS.
- Being tested
- Brainsway H1-Coil Deep TMS System
- Keywords
- dTMS, depression, magnetic, iTBS
- Medical subject headings
- Depressive Disorder, Major, Alzheimer Disease, Cognitive Dysfunction, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brainsway H1-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 daily for 4 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active H1 Coil deep rTMS active treatment | Experimental | Not described Receives: Device: Brainsway H1-Coil Deep TMS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS)
Therapeutic efficacy will be evaluated with the MADRS, a 10-item checklist. An effect size (Cohen's d) of 0.5 will be considered a minimally important effect size.
Measured: 4 weeks
Secondary outcomes (7)
Remission Rates Compared Within Treatment Group
Remission defined as MADRS < 10.
Measured: 4 weeks
Response Rates Compared Within Treatment Group
Response rate refers to the percentage of patients who responded to dTMS treatment and response is defined as a ≥50% reduction in MADRS score from baseline.
Measured: 4 weeks
Change From Baseline on the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
This 16-item questionnaire is designed to help assess the degree of enjoyment and satisfaction experienced during the past week. Administration time is approximately 5 minutes.
Measured: 4 weeks
Change From Baseline on the Neuropsychological Battery
Cognitive scores from the neuropsychological battery at baseline will be compared to 4 weeks post-intervention Cognitive domains tested include executive function, memory, language, attention, and intelligence.
Measured: 4 weeks
Change in Functional Connectivity between PFC and Limbic Regions
Subjects will have magnetic resonance imaging (MRI) scans of the brain. The change in functional connectivity between PFC and limbic regions, and within the default mode network, at rest is measured using resting state fMRI.
Measured: 4 weeks
Change in Perfusion within Prefrontal Cortex (PFC) and Posterior Cingulate Cortex (PCC)
Measured using Arterial Spin Labeling (ASL) fMRI scan.
Measured: 4 weeks
Change in frontal theta power within the Anterior Cingulate Cortex (ACC)
Measured with electroencephalography (EEG) and/or magnetoencephalography (MEG).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start23 Oct 2018
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rotman Research Institute at Baycrest
- Sponsor type
- University, hospital or other
- Collaborators
- Brainsway, Centre for Addiction and Mental Health
- Responsible party
- Principal investigator, Linda Mah, MD, Rotman Research Institute at Baycrest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665831
- Sponsor's protocol ID
- CICP-2-00095
- Status last verified
- Apr 2025
- First submitted
- 7 Sep 2018
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Hodzic-Santor BH, Meltzer JA, Verhoeff NPLG, Blumberger DM, Mah L. Safety, tolerability, and feasibility of deep transcranial magnetic stimulation for late-life depression with comorbid major or mild neurocognitive disorder. Int Psychogeriatr. 2021 Jan;33(1):99-101. doi: 10.1017/S1041610220003543. Epub 2020 Nov 6. No abstract available.
PubMed 33153503
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Comorbid Depression and Cognitive Impairment in Older Adults With Neurocognitive Disorders Using Deep Transcranial Magnetic Stimulation (dTMS)
- ClinicalTrials.gov ID
- NCT03665831
- Acronym / sponsor ID
- CICP-2-00095
- Keywords
- dTMS, depression, magnetic, iTBS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Rotman Research Institute at BaycrestUniversity, hospital or other
- Collaborators
- Brainsway, Centre for Addiction and Mental Health
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 11 Sep 2018 (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.
In this study, the investigators will be examining the effects of the deep repetitive transcranial magnetic stimulation (rTMS) using the H1 coil in patients over the age of 60 diagnosed with mild to early-moderate Alzheimer's disease (AD) or mild cognitive impairment (MCI) and comorbid Major Depressive Disorder (MDD) who have been unable to tolerate or failed to respond to antidepressant medications. The coil was designed to stimulate deeper regions of the left dorsolateral prefrontal cortex (DLPFC). Based on prior research, the investigators propose that active stimulation with the H1 coil for 4 weeks may result in significant remission rates and will be tolerable and safe.
Detailed description
This study is an open-label trial to evaluate the safety and efficacy of H1-coil dTMS in treating depression in MCI and mild AD patients over 60 years of age who have not tolerated or failed to respond to antidepressant medications. 28 patients will be assigned to receive 4 consecutive weeks of daily active dTMS treatment. The long-term effects of treatment on emotional cognitive measures will be assessed at a 4-week follow-up visit (8 weeks from baseline). Symptom change and remission criteria will be assessed using the Montogmery-Asberg Depression Rating Scale (MADRS). Cognition will be assessed using a validated neuropsychological battery.
We will also offer patients to receive 4 weeks of treatment using theta-burst TMS, which is a milder version of TMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active H1 Coil deep rTMS active treatment | Experimental | Device: Brainsway H1-Coil Deep TMS System |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- meet DSM 5 criteria for Major or Mild Neurocognitive Disorder due to Alzheimer's disease with Clinical Dementia Rating Scale (CDR) score of at least 0.5
- 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 or did not tolerate antidepressant treatment
- are willing to provide informed consent
- are able to follow the treatment schedule
Key exclusion criteria (18 listed)
- have a metal plate in their head, except in the mouth (such as an ear implant, implanted brain stimulators, aneurysm clips)
- 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 |
|---|---|---|
| Brainsway H1-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 daily for 4 consecutive weeks. | Device | Active H1 Coil deep rTMS active treatment |
Primary outcome
Change From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 4 weeks
Therapeutic efficacy will be evaluated with the MADRS, a 10-item checklist. An effect size (Cohen's d) of 0.5 will be considered a minimally important effect size.
7 secondary outcomes
Remission Rates Compared Within Treatment Group
Time frame: 4 weeks
Response Rates Compared Within Treatment Group
Time frame: 4 weeks
Change From Baseline on the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Time frame: 4 weeks
Change From Baseline on the Neuropsychological Battery
Time frame: 4 weeks
Change in Functional Connectivity between PFC and Limbic Regions
Time frame: 4 weeks
Change in Perfusion within Prefrontal Cortex (PFC) and Posterior Cingulate Cortex (PCC)
Time frame: 4 weeks
Change in frontal theta power within the Anterior Cingulate Cortex (ACC)
Time frame: 4 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 27 Oct 2025.
- Derived from this study: PubMed 33153503Hodzic-Santor BH, Meltzer JA, Verhoeff NPLG, Blumberger DM, Mah L. Safety, tolerability, and feasibility of deep transcranial magnetic stimulation for late-life depression with comorbid major or mild neurocognitive disorder. Int Psychogeriatr. 2021 Jan;33(1):99-101. doi: 10.1017/S1041610220003543. Epub 2020 Nov 6. No abstract available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brainsway H1-Coil Deep TMS System in people with Major Depressive Disorder and Alzheimer Disease, 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 8 inclusion and 18 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 27 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. 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 Rahmadian, BSc (416-785-2500 ext. 3434, dtms@research.baycrest.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03665831, which also lists 1 linked publication.
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 27 Oct 2025.