Mild Cognitive Impairment (MCI)NACC-ECNCT07212504
Effect of Accelerated Neuromodulation of Anterior Cingulate Cortex to Enhance Cognition in Older Adults With Mild Memory Problems
A study testing Active Brainsway H7-Coil Deep TMS System in people with Mild Cognitive Impairment (MCI) and Subjective Cognitive Decline (SCD), 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 in combination with cognitive training can improve cognitive abilities in older adults with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI). Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Subjective Cognitive Decline (SCD)
- 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
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2025to 15 Mar 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 55 - 85 years of age (on the day of randomization)
- are male or post-menopausal female
- have a diagnosis of mild cognitive impairment (MCI) based on Montreal Cognitive Assessment score < 26 or where available, results from clinical neuropsychological assessment, OR subjective memory concerns and first degree relative, living or deceased, with a probable or confirmed diagnosis of AD
- score 24 or higher on the Mini Mental State Examination (MMSE)
- 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 their 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
- 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
The goal of this clinical trial is to test whether an accelerated deep Transcranial Magnetic Stimulation (dTMS) protocol in combination with cognitive training can improve cognitive abilities in older adults with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI). The study will look at whether it is safe and tolerable to use accelerated dTMS to enhance the benefits of cognitive training in older adults, and will also gather early information on the effects of accelerated dTMS on memory and other cognitive abilities.
Read the detailed description
This study will examine the effects of combining cognitive remediation with accelerated intermittent theta burst stimulation (a-iTBS) using the H7 deep Transcranial Magnetic Stimulation (dTMS) coil to target the anterior cingulate cortex (ACC) in older adults aged 55-85 with MCI or SCD. Thirty older adults will participate in a single site, double-blind, randomized sham-controlled trial using an accelerated schedule of multiple dTMS sessions per day for 2-5 consecutive days, followed by 6 weeks of online cognitive remediation for both sham and dTMS interventions. The primary goal of the study is to establish the feasibility of an a-iTBS protocol combined with cognitive training in older adults with Mild Cognitive Impairment (MCI) and Subjective Cognitive Decline (SCD) and to obtain preliminary evidence of treatment efficacy.
- Being tested
- Active Brainsway H7-Coil Deep TMS System, Sham Brainsway H1-Coil Deep TMS System
- Keywords
- Mild Cognitive Impairment, Subjective Cognitive Decline, Transcranial Magnetic Stimulation (TMS), Intermittent Theta Burst Stimulation
- Medical subject headings
- Cognitive Dysfunction
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 2-5 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 using the H1-coil helmet 6-8 times a day for 2-5 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| 20-40 sessions of iTBS dTMS and 6-weeks of online cognitive remediation | Experimental | Not described Receives: Device: Active Brainsway H7-Coil Deep TMS System |
| 20-40 sessions of sham stimulation and 6-weeks of online cognitive remediation | Sham comparator | Not described Receives: Device: Sham Brainsway H1-Coil Deep TMS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of dTMS sessions attended by participants
Measured: 1 week
Incidence and type of of adverse events experienced during treatment (participant-reported tolerability) based on the Adverse Events Questionnaire (AEQ)
The AEQ asks about symptoms related immediately after TMS administration where patients rate symptom severity from 1 (absent) to 4 (severe) and whether they believe it is related to TMS from 1 (no) to 5 (definitely).
Measured: 9 weeks
The number of participants who prematurely withdraw and reasons for withdrawal
Measured: 9 weeks
Change from baseline memory scores on computerized neuropsychological battery following the final session on day 5
Memory score from memory tests in the neuropsychological battery at baseline will be compared to after 5 days of TMS and after 6 weeks of cognitive training the active intervention group compared to the sham. A higher memory score indicates better memory performance. An effect size (Cohen's d) of 0.5 will be considered a minimally important effect size.
Measured: 9 weeks
Change from baseline executive function scores on computerized neuropsychological battery following final session on day 5
Executive function scores from tests on the neuropsychological battery will be compared from baseline to after days of dTMS and after 6 weeks of cognitive training in the active intervention group compared to sham. A higher score on these tests indicate greater executive functioning. An effect size (Cohen's d) of 0.5 will be considered a minimally important effect size.
Measured: 9 weeks
Secondary outcomes (6)
The change in baseline in scores on the Geriatric Anxiety Inventory (GAI) following 5 days of dTMS
The GAI is a 20-item self-report measure of anxiety developed for older adults. Administration time is approximately 5 minutes. The GAI scores range from 0-20, with higher scores indicating more anxiety.
Measured: 1 week
The change in resting state activity as measured with electroencephalography (EEG) following 5 days of dTMS
Measured: 1 week
The change in slow wave activity in the posterior default mode network (posterior cingulate cortex) as measured with MEG following 5 days of dTMS
Measured: 1 week
The change in functional connectivity within the default mode network based on Magnetic Resonance Imaging (MRI) following 5 days of dTMS
Measured: 1 week
The 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. GDS scores range from 0-15 with a greater score indicating greater depressive symptoms.
Measured: 1 week
The change in baseline slow wave as measured with electroencephalography (EEG) following 5 days of dTMS
Measured: 1 week
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 start15 Nov 2025 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)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
- 30 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
- NCT07212504
- Sponsor's protocol ID
- 25-04
- Acronym
- NACC-EC
- 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
- Effect of Accelerated Neuromodulation of Anterior Cingulate Cortex to Enhance Cognition in Older Adults With Mild Memory Problems
- ClinicalTrials.gov ID
- NCT07212504
- Acronym / sponsor ID
- NACC-EC / 25-04
- Keywords
- Mild Cognitive Impairment, Subjective Cognitive Decline, Transcranial Magnetic Stimulation (TMS), Intermittent Theta Burst Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rotman Research Institute at BaycrestUniversity, hospital or other
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 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 in combination with cognitive training can improve cognitive abilities in older adults with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI). The study will look at whether it is safe and tolerable to use accelerated dTMS to enhance the benefits of cognitive training in older adults, and will also gather early information on the effects of accelerated dTMS on memory and other cognitive abilities.
Detailed description
This study will examine the effects of combining cognitive remediation with accelerated intermittent theta burst stimulation (a-iTBS) using the H7 deep Transcranial Magnetic Stimulation (dTMS) coil to target the anterior cingulate cortex (ACC) in older adults aged 55-85 with MCI or SCD. Thirty older adults will participate in a single site, double-blind, randomized sham-controlled trial using an accelerated schedule of multiple dTMS sessions per day for 2-5 consecutive days, followed by 6 weeks of online cognitive remediation for both sham and dTMS interventions. The primary goal of the study is to establish the feasibility of an a-iTBS protocol combined with cognitive training in older adults with Mild Cognitive Impairment (MCI) and Subjective Cognitive Decline (SCD) 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 iTBS dTMS and 6-weeks of online cognitive remediation | Experimental | Device: Active Brainsway H7-Coil Deep TMS System |
| 20-40 sessions of sham stimulation and 6-weeks of online cognitive remediation | Sham comparator | Device: Sham Brainsway H1-Coil Deep TMS System |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 55 - 85 years of age (on the day of randomization)
- are male or post-menopausal female
- have a diagnosis of mild cognitive impairment (MCI) based on Montreal Cognitive Assessment score < 26 or where available, results from clinical neuropsychological assessment, OR subjective memory concerns and first degree relative, living or deceased, with a probable or confirmed diagnosis of AD
- score 24 or higher on the Mini Mental State Examination (MMSE)
- are willing to provide informed consent
Key exclusion criteria (17 listed)
- have a metal plate in their 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 2-5 consecutive days. | Device | 20-40 sessions of iTBS dTMS and 6-weeks of online cognitive remediation |
| 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 using the H1-coil helmet 6-8 times a day for 2-5 consecutive days. | Device | 20-40 sessions of sham stimulation and 6-weeks of online cognitive remediation |
Primary outcome
Percentage of dTMS sessions attended by participants
Time frame: 1 week
Incidence and type of of adverse events experienced during treatment (participant-reported tolerability) based on the Adverse Events Questionnaire (AEQ)
Time frame: 9 weeks
The AEQ asks about symptoms related immediately after TMS administration where patients rate symptom severity from 1 (absent) to 4 (severe) and whether they believe it is related to TMS from 1 (no) to 5 (definitely).
The number of participants who prematurely withdraw and reasons for withdrawal
Time frame: 9 weeks
Change from baseline memory scores on computerized neuropsychological battery following the final session on day 5
Time frame: 9 weeks
Memory score from memory tests in the neuropsychological battery at baseline will be compared to after 5 days of TMS and after 6 weeks of cognitive training the active intervention group compared to the sham. A higher memory score indicates better memory performance. An effect size (Cohen's d) of 0.5 will be considered a minimally important effect size.
Change from baseline executive function scores on computerized neuropsychological battery following final session on day 5
Time frame: 9 weeks
Executive function scores from tests on the neuropsychological battery will be compared from baseline to after days of dTMS and after 6 weeks of cognitive training in the active intervention group compared to sham. A higher score on these tests indicate greater executive functioning. An effect size (Cohen's d) of 0.5 will be considered a minimally important effect size.
6 secondary outcomes
The change in baseline in scores on the Geriatric Anxiety Inventory (GAI) following 5 days of dTMS
Time frame: 1 week
The change in resting state activity as measured with electroencephalography (EEG) following 5 days of dTMS
Time frame: 1 week
The change in slow wave activity in the posterior default mode network (posterior cingulate cortex) as measured with MEG following 5 days of dTMS
Time frame: 1 week
The change in functional connectivity within the default mode network based on Magnetic Resonance Imaging (MRI) following 5 days of dTMS
Time frame: 1 week
The change in baseline in scores on the Geriatric Depression Scale (GDS)
Time frame: 1 week
The change in baseline slow wave as measured with electroencephalography (EEG) following 5 days of dTMS
Time frame: 1 week
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 Mild Cognitive Impairment (MCI) and Subjective Cognitive Decline (SCD), 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 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 dTMS sessions attended by participants (time frame: 1 week). The study lists 5 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.