Alzheimer DiseaseNCT06095063
dTMS for Subjective Cognitive Decline
A study testing Active Brainsway H7-Coil Deep TMS System and Cognitive Training in people with Alzheimer Disease and Subjective Cognitive Decline, run by Rotman Research Institute at Baycrest at 1 site in Canada.
Trial summary
Deep transcranial magnetic stimulation (dTMS) is a brain stimulation technique that involves generating a brief magnetic field in a coil that is placed on the scalp. The magnetic field passes through the skull and induces a weak electrical current in the brain that briefly activates neural circuits at the stimulation… Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Alzheimer Disease, Subjective Cognitive Decline
- What is being tested?
- Active Brainsway H7-Coil Deep TMS System and Cognitive Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2023to 15 Nov 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 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have a family history of late onset sporadic Alzheimer's disease (AD) as defined by having a first degree relative, living or deceased, with a probable or confirmed diagnosis of AD
- have subjective memory decline and concern about memory changes
- score 26 or higher on the Montreal Cognitive Assessment (MoCA)
- 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 condition
Show all 18Show fewer
- have current depression or 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
- have a history of abnormal MRI of the brain
- have significant hearing loss requiring use of hearing aids
- have untreated hypo- or hyper-thyroidism
- have TMS contraindications
- have unstable medical condition(s)
- regularly use benzodiazepines or other hypnotics within 2 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: Effect of Deep Transcranial Magnetic Stimulation (dTMS) on Cognition in Older Adults With Subjective Cognitive Decline (SCD)
Deep transcranial magnetic stimulation (dTMS) is a brain stimulation technique that involves generating a brief magnetic field in a coil that is placed on the scalp. The magnetic field passes through the skull and induces a weak electrical current in the brain that briefly activates neural circuits at the stimulation site. The Brainsway dTMS H7-Coil is able to target an area of the brain that has been shown in studies to be linked to greater resilience to cognitive decline. In this study, the investigators will combine dTMS with cognitive training in older adults with subjective cognitive decline (SCD) and examine the effect of this treatment on memory, other cognitive abilities, and mood. In addition, the investigators will examine the combined effects of dTMS and cognitive training on brain activity as measured using electroencephalography (EEG).
Approximately 30 older adults from ages 55 to 70 with SCD and a positive family history of Alzheimer's disease will be enrolled in this study.
Read the detailed description
This study will examine the effects of combining cognitive remediation with neurostimulation using deep transcranial magnetic stimulation (dTMS) and the H7-coil to target the anterior cingulate cortex (ACC) in older adults at risk for developing Alzheimer's disease (AD). Thirty older adults with subjective cognitive decline (SCD) and a family history of AD will participate in a single-site randomized double-blind sham-controlled cross-over trial of dTMS of the ACC in conjunction with active cognitive remediation for both sham and dTMS interventions. The primary goal of the study is to establish the feasibility of dTMS and cognitive training as a means to improve cognitive abilities in SCD. Secondary goals are to obtain preliminary evidence of improvement in executive function and memory abilities following dTMS and cognitive training. This trial is a first step towards developing effective neurostimulation protocols to reduce cognitive decline in older adults at risk for developing AD.
- Conditions
- Alzheimer Disease, Subjective Cognitive Decline
- Being tested
- Active Brainsway H7-Coil Deep TMS System, Sham Brainsway H7-Coil Deep TMS System, Cognitive Training
- Medical subject headings
- Alzheimer Disease
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 daily for 4 consecutive weeks.
Sham Brainsway H7-Coil Deep TMS SystemDevice
In addition to the active H-coil, a sham coil is included in the system. The active and sham coils are connected to a control switch, which alternates between real and sham operation modes. The sham treatment will be administered daily for 4 consecutive weeks.
Cognitive TrainingOther
Cognitive training will be conducted using the BrainHQ software program.
| Study group | Role | What they receive |
|---|---|---|
| 20 sessions of dTMS and Cognitive Training | Experimental | Participants will receive dTMS followed by computerized cognitive training.
dTMS: The motor threshold (MT) will be measured by delivering single stimulations to the motor cortex with gradually increased intensity. After defining the MT, the coil will be positioned anterior to the hot spot using the ruler on the participant's cap, and a dTMS session will be performed with the dosing of the stimulus intensity titrated slowly to approximately 120% of the motor threshold. On Day 1 of the treatment, stimulation will be delivered at an intensity ranging from 80% to 100% of the participant's MT depending on their initial tolerance to the stimulation. Stimulation intensity will then be slowly titrated by sequentially increasing the intensity by 10% over the remaining days of the first week until a maximum intensity of 120% of MT is achieved depending on the tolerability of the patient.
Immediately following dTMS, participants will complete 20-30 minutes of cognitive training. Receives: Device: Active Brainsway H7-Coil Deep TMS System; Other: Cognitive Training |
| 20 sessions of sham/control stimulation and Cognitive Training | Sham comparator | Participants will receive sham intervention followed by computerized cognitive training.
The sham intervention consists of treatment with similar technical parameters which induce scalp sensations but do not penetrate into the brain.
Immediately following dTMS, participants will complete 20-30 minutes of cognitive training. Receives: Device: Sham Brainsway H7-Coil Deep TMS System; Other: Cognitive Training |
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
There are in total 20 sessions of dTMS intervention and 20 sessions of sham stimulation.
Measured: 19 weeks
Secondary outcomes (6)
Change in baseline memory performance on a neuropsychological battery
Memory score from the neuropsychological battery at baseline will be compared to 4 weeks of intervention and at 1-month follow-up.
Measured: 19 weeks
Change in executive function performance on a neuropsychological battery
Executive function scores from the neuropsychological battery at baseline will be compared to 4 weeks of intervention and at 1-month follow-up.
Measured: 19 weeks
Change in baseline in scores on the Geriatric Depression Scale (GDS).
GDS is a 15-item self-report scale that measures an elderly individual's mood. A score greater than 5 suggests that the individual may be depressed. Administration time is approximately 5 minutes.
The scores at baseline will be compared to 4 weeks of intervention and at 1-month follow-up.
Measured: 19 weeks
Change in baseline in scores on the Geriatric Anxiety Inventory (GAI).
The GAI is a 20-item self-report measure of anxiety developed for older adults. Administration time is approximately 5 minutes.
The scores at baseline will be compared to 4 weeks of intervention and at 1-month follow-up.
Measured: 19 weeks
Change in baseline in scores on the Neuropsychiatric Inventory Questionnaire (NPI-Q)
The NPI assesses dementia-related behavioural symptoms including delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, aberrant motor activity, night-time behavioural disturbances and appetite and eating abnormalities. Administration time is approximately 15 minutes.
The scores at baseline will be compared to 4 weeks of intervention and at 1-month follow-up.
Measured: 19 weeks
Change in slow wave and resting state activity
Measured with electroencephalography (EEG) following 4 weeks of intervention and at 1-month follow-up.
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start15 Nov 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 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
- Investigators
- Linda Mah, Principal investigator, Baycrest Rotman Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095063
- Sponsor's protocol ID
- 21-01
- Status last verified
- Sep 2025
- First submitted
- 11 Oct 2023
- Last updated
- 27 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 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Deep Transcranial Magnetic Stimulation (dTMS) on Cognition in Older Adults With Subjective Cognitive Decline (SCD)
- ClinicalTrials.gov ID
- NCT06095063
- Acronym / sponsor ID
- 21-01
- Conditions
- Alzheimer Disease, Subjective Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rotman Research Institute at BaycrestUniversity, hospital or other
- Collaborators
- Brainsway, Centre for Addiction and Mental Health
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 23 Oct 2023 (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.
Deep transcranial magnetic stimulation (dTMS) is a brain stimulation technique that involves generating a brief magnetic field in a coil that is placed on the scalp. The magnetic field passes through the skull and induces a weak electrical current in the brain that briefly activates neural circuits at the stimulation site. The Brainsway dTMS H7-Coil is able to target an area of the brain that has been shown in studies to be linked to greater resilience to cognitive decline. In this study, the investigators will combine dTMS with cognitive training in older adults with subjective cognitive decline (SCD) and examine the effect of this treatment on memory, other cognitive abilities, and mood. In addition, the investigators will examine the combined effects of dTMS and cognitive training on brain activity as measured using electroencephalography (EEG).
Approximately 30 older adults from ages 55 to 70 with SCD and a positive family history of Alzheimer's disease will be enrolled in this study.
Detailed description
This study will examine the effects of combining cognitive remediation with neurostimulation using deep transcranial magnetic stimulation (dTMS) and the H7-coil to target the anterior cingulate cortex (ACC) in older adults at risk for developing Alzheimer's disease (AD). Thirty older adults with subjective cognitive decline (SCD) and a family history of AD will participate in a single-site randomized double-blind sham-controlled cross-over trial of dTMS of the ACC in conjunction with active cognitive remediation for both sham and dTMS interventions. The primary goal of the study is to establish the feasibility of dTMS and cognitive training as a means to improve cognitive abilities in SCD. Secondary goals are to obtain preliminary evidence of improvement in executive function and memory abilities following dTMS and cognitive training. This trial is a first step towards developing effective neurostimulation protocols to reduce cognitive decline in older adults at risk for developing AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20 sessions of dTMS and Cognitive Training | Experimental | Device: Active Brainsway H7-Coil Deep TMS System, Other: Cognitive TrainingParticipants will receive dTMS followed by computerized cognitive training. dTMS: The motor threshold (MT) will be measured by delivering single stimulations to the motor cortex with gradually increased intensity. After defining the MT, the coil will be positioned anterior to the hot spot using the ruler on the participant's cap, and a dTMS session will be performed with the dosing of the stimulus intensity titrated slowly to approximately 120% of the motor threshold. On Day 1 of the treatment, stimulation will be delivered at an intensity ranging from 80% to 100% of the participant's MT depending on their initial tolerance to the stimulation. Stimulation intensity will then be slowly titrated by sequentially increasing the intensity by 10% over the remaining days of the first week until a maximum intensity of 120% of MT is achieved depending on the tolerability of the patient. Immediately following dTMS, participants will complete 20-30 minutes of cognitive training. |
| 20 sessions of sham/control stimulation and Cognitive Training | Sham comparator | Device: Sham Brainsway H7-Coil Deep TMS System, Other: Cognitive TrainingParticipants will receive sham intervention followed by computerized cognitive training. The sham intervention consists of treatment with similar technical parameters which induce scalp sensations but do not penetrate into the brain. Immediately following dTMS, participants will complete 20-30 minutes of cognitive training. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- have a family history of late onset sporadic Alzheimer's disease (AD) as defined by having a first degree relative, living or deceased, with a probable or confirmed diagnosis of AD
- have subjective memory decline and concern about memory changes
- score 26 or higher on the Montreal Cognitive Assessment (MoCA)
- 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 |
|---|---|---|
| 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 daily for 4 consecutive weeks. | Device | 20 sessions of dTMS and Cognitive Training |
| Sham Brainsway H7-Coil Deep TMS SystemIn addition to the active H-coil, a sham coil is included in the system. The active and sham coils are connected to a control switch, which alternates between real and sham operation modes. The sham treatment will be administered daily for 4 consecutive weeks. | Device | 20 sessions of sham/control stimulation and Cognitive Training |
| Cognitive TrainingCognitive training will be conducted using the BrainHQ software program. | Other | 20 sessions of dTMS and Cognitive Training, 20 sessions of sham/control stimulation and Cognitive Training |
Primary outcome
Percentage of scheduled treatment sessions that are attended by study participants
Time frame: 19 weeks
There are in total 20 sessions of dTMS intervention and 20 sessions of sham stimulation.
6 secondary outcomes
Change in baseline memory performance on a neuropsychological battery
Time frame: 19 weeks
Change in executive function performance on a neuropsychological battery
Time frame: 19 weeks
Change in baseline in scores on the Geriatric Depression Scale (GDS).
Time frame: 19 weeks
Change in baseline in scores on the Geriatric Anxiety Inventory (GAI).
Time frame: 19 weeks
Change in baseline in scores on the Neuropsychiatric Inventory Questionnaire (NPI-Q)
Time frame: 19 weeks
Change in slow wave and resting state activity
Time frame: 17 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.
Related trials for Alzheimer Disease
Not yet recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-08161842 Are Tolerated and Act in the Body in Healthy and Older Adults
Alzheimer Disease
Active, not recruiting
Emergency Preparedness for Caregivers of Persons With Dementia: Disaster PrepWise
Caregiver Resilience and Stress
Active, not recruitingObservational study
A Community-Based Screening Program to Identify Participants at High Risk for Amyloid Pathology
Alzheimer's Disease
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
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 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 and Cognitive Training in people with Alzheimer Disease and Subjective Cognitive Decline, 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. 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 Rahmadian (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?
Percentage of scheduled treatment sessions that are attended by study participants (time frame: 19 weeks). 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 27 Oct 2025.