Testing Active Brainsway H7-Coil Deep TMS System against a placebo for mild cognitive impairment (MCI)
Official title: Effect of Accelerated Neuromodulation of Anterior Cingulate Cortex to Enhance Cognition in Older Adults With Mild Memory Problems
- 2 groups
- One site, in Toronto
- Recruiting
Interventions
- Medical device
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 2-5 consecutive days.
- Medical 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 using the H1-coil helmet 6-8 times a day for 2-5 consecutive days.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Rotman Research Institute at Baycrest
Toronto, Ontario
Eligibility Criteria
See who this study is looking for25 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +55 - 85 years of age (on the day of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →)
- +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more → questionnaire for TMS
Exclusion
- −have a history of stroke or other brain lesions
- −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
- −have a history of substance abuse in the last 6 months
- −have a personal history of epilepsy
- −have a family history of epilepsy
- −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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- −are a pregnant or breast-feeding woman
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Active Brainsway H7-Coil Deep TMS System.
Registry label: A: 20-40 sessions of iTBS dTMS and 6-weeks of online cognitive remediation
Group B, the shamSham procedureA procedure made to feel like the real one, without the active step.Read more → group, receives Sham Brainsway H1-Coil Deep TMS System.
Registry label: B: 20-40 sessions of sham stimulation and 6-weeks of online cognitive remediation
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a sham procedureSham procedureA procedure made to feel like the real one, without the active step.Read more → — one made to feel like the real thing but without the active step.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 55 years to 85 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 30 people.
The study is currently expected to finish around March 2027.
The main measurement is taken over: 1 week.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Percentage of dTMS sessions attended by participants — measured over 1 week.
Incidence and type of of adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → experienced during treatment (participant-reported tolerability) based on the Adverse Events Questionnaire (AEQ) — measured over 9 weeks.
The number of participants who prematurely withdraw and reasons for withdrawal — measured over 9 weeks.
Change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → memory scores on computerized neuropsychological battery following the final session on day 5 — measured over 9 weeks.
The study lists 1 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07212504 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About 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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 55 years to 85 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study includes a shamSham procedureA procedure made to feel like the real one, without the active step.Read more → comparison — a procedure made to feel like the real one, without the active step.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 55 years to 85 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 1 week.
The study as a whole is currently expected to finish around 2027-03-15.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 30 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.