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Clinical Trials in Canada / NCT06095063
Recruiting Not applicable

dTMS for Subjective Cognitive Decline

NCT06095063 · tracked via the Priya Life Science Canada tracker
Sponsor
Rotman Research Institute at Baycrest
Phase
Not applicable
Started
2023-11-15
Last updated
2025-10-27

Condition(s) studied

Alzheimer DiseaseSubjective Cognitive Decline

Investigational drug(s) / intervention(s)

Active Brainsway H7-Coil Deep TMS SystemSham Brainsway H7-Coil Deep TMS SystemCognitive Training

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.

Study 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.

Eligibility

Sex
ALL
Min age
55 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Percentage of scheduled treatment sessions that are attended by study participants — 19 weeks
    There are in total 20 sessions of dTMS intervention and 20 sessions of sham stimulation.

Trial sites (1)

FacilityCityRegionStatus
Rotman Research Institute at Baycrest Toronto Ontario Recruiting

More Rotman Research Institute at Baycrest trials in Canada

Deep TMS for Comorbid Depression and Cognitive Impairment in Older Adults Recruiting
Effect of Accelerated Neuromodulation of Anterior Cingulate Cortex to Enhance Cognition in Older Adults With Mild Memory Problems Recruiting
Accelerated Neuromodulation of Anterior Cingulate Cortex for Depression Recruiting

Other trials for the same condition

Clinical Trial on Agitation in Alzheimer's Dementia Active, not recruiting
Combined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia Recruiting
rTMS for Apathy Clinical Trial Recruiting
Deep TMS for Comorbid Depression and Cognitive Impairment in Older Adults Recruiting
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06095063 on ClinicalTrials.gov ↗ ← All trials in Canada