dTMS for Subjective Cognitive Decline

Rotman Research Institute at Baycrest

Status: Enrolling

Conditions: Alzheimer Disease; Subjective Cognitive Decline

Treatments: Other: Cognitive Training; Device: Active Brainsway H7-Coil Deep TMS System; Device: Sham Brainsway H7-Coil Deep TMS System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06095063

21-01

Details and patient eligibility

About

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.

Full description

This study will examine the effects of combining cognitive remediation with neurostimulation using deep transcranial magnetic stimulation (dTMS) and the H7-coil to target the anterior cingulate cortex (ACC) in older adults at risk for developing Alzheimer's disease (AD). Thirty older adults with subjective cognitive decline (SCD) and a family history of AD will participate in a single-site randomized double-blind sham-controlled cross-over trial of dTMS of the ACC in conjunction with active cognitive remediation for both sham and dTMS interventions. The primary goal of the study is to establish the feasibility of dTMS and cognitive training as a means to improve cognitive abilities in SCD. Secondary goals are to obtain preliminary evidence of improvement in executive function and memory abilities following dTMS and cognitive training. This trial is a first step towards developing effective neurostimulation protocols to reduce cognitive decline in older adults at risk for developing AD.

Enrollment: 30 estimated patients

Sex: All

Ages: 55 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

20 sessions of dTMS and Cognitive Training

Experimental group

Description:

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.

Treatment:

Other: Cognitive Training

Device: Active Brainsway H7-Coil Deep TMS System

20 sessions of sham/control stimulation and Cognitive Training

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Brainsway H7-Coil Deep TMS System

Other: Cognitive Training