dTMS for Subjective Cognitive Decline
Effect of Deep Transcranial Magnetic Stimulation (dTMS) on Cognition in Older Adults With Subjective Cognitive Decline (SCD)
1 other identifier
interventional
30
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable alzheimer-disease
Started Nov 2023
Typical duration for not_applicable alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2023
CompletedFirst Posted
Study publicly available on registry
October 23, 2023
CompletedStudy Start
First participant enrolled
November 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 15, 2026
October 27, 2025
September 1, 2025
2.9 years
October 11, 2023
October 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
19 weeks
Secondary Outcomes (6)
Change in baseline memory performance on a neuropsychological battery
19 weeks
Change in executive function performance on a neuropsychological battery
19 weeks
Change in baseline in scores on the Geriatric Depression Scale (GDS).
19 weeks
Change in baseline in scores on the Geriatric Anxiety Inventory (GAI).
19 weeks
Change in baseline in scores on the Neuropsychiatric Inventory Questionnaire (NPI-Q)
19 weeks
- +1 more secondary outcomes
Study Arms (2)
20 sessions of dTMS and Cognitive Training
EXPERIMENTALParticipants 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 COMPARATORParticipants 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.
Interventions
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.
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 training will be conducted using the BrainHQ software program.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rotman Research Institute at Baycrestlead
- Brainswaycollaborator
- Centre for Addiction and Mental Healthcollaborator
Study Sites (1)
Rotman Research Institute at Baycrest
Toronto, Ontario, M6A 2E1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Linda Mah
Baycrest Rotman Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinician Scientist
Study Record Dates
First Submitted
October 11, 2023
First Posted
October 23, 2023
Study Start
November 15, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
November 15, 2026
Last Updated
October 27, 2025
Record last verified: 2025-09