Recruiting

dTMS

Sponsor:

Rotman Research Institute at Baycrest

Code:

NCT06095063

Conditions

Alzheimer Disease

Subjective Cognitive Decline

Eligibility Criteria

Sex: All

Age: 55 - 70

Healthy Volunteers: Not accepted

Interventions

Active Brainsway H7-Coil Deep TMS System

Sham Brainsway H7-Coil Deep TMS System

Cognitive Training

Study Details

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.

Conditions

Alzheimer Disease

Subjective Cognitive Decline

Study ID

NCT06095063

Start date

Nov 15, 2023

Status verified date

Sep, 2025

Completion date

Nov 15, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • have TMS contraindications
  • have unstable medical condition(s)
  • regularly use benzodiazepines or other hypnotics within 2 weeks of randomization

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 20 sessions of dTMS and Cognitive Training

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.

sham comparator: 20 sessions of sham/control stimulation and Cognitive Training

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.

Interventions

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 daily for 4 consecutive weeks.

Sham Brainsway H7-Coil Deep TMS System

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

Cognitive training will be conducted using the BrainHQ software program.

Primary outcome measure

  • Percentage of scheduled treatment sessions that are attended by study participants [ Time Frame: 19 weeks ]

Central Contacts and Locations

Central contacts

Amanda Rahmadian

416-785-2500dtms@research.baycrest.org

Linda Mah

416-785-2500preventad@research.baycrest.org

Locations

Rotman Research Institute at Baycrest

Recruiting

Toronto, Ontario, Canada, M6A 2E1

Contacts

Linda Mah, MD

416-785-2500preventad@research.baycrest.org

More Information

Sponsor

Rotman Research Institute at Baycrest

Last update posted

Oct 27, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rotman Research Institute at Baycrest on 2025-10-27.