Health TrialsbyHealthPanel

dTMS for Subjective Cognitive Decline

ConditionsAlzheimer DiseaseSubjective Cognitive Decline
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-70
SponsorRotman Research Institute at Baycrest

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Active Brainsway H7-Coil Deep TMS System

    Device

    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

    Device

    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

    Other intervention

    Cognitive training will be conducted using the BrainHQ software program.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: 20 sessions of dTMS and Cognitive TrainingExperimental treatment 2 interventions
Group B: 20 sessions of sham/control stimulation and Cognitive TrainingSham comparator 2 interventions

Trial outcomes

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.

Time frame
19 weeks

Secondary outcomes

1

Change in baseline memory performance on a neuropsychological battery

Memory score from the neuropsychological battery at baseline will be compared to 4 weeks of intervention and at 1-month follow-up.

Time frame
19 weeks
2

Change in executive function performance on a neuropsychological battery

Executive function scores from the neuropsychological battery at baseline will be compared to 4 weeks of intervention and at 1-month follow-up.

Time frame
19 weeks
3

Change in baseline in scores on the Geriatric Depression Scale (GDS).

GDS is a 15-item self-report scale that measures an elderly individual's mood. A score greater than 5 suggests that the individual may be depressed. Administration time is approximately 5 minutes. The scores at baseline will be compared to 4 weeks of intervention and at 1-month follow-up.

Time frame
19 weeks
4

Change in baseline in scores on the Geriatric Anxiety Inventory (GAI).

The GAI is a 20-item self-report measure of anxiety developed for older adults. Administration time is approximately 5 minutes. The scores at baseline will be compared to 4 weeks of intervention and at 1-month follow-up.

Time frame
19 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rotman Research Institute at Baycrest

Lead sponsor

Brainsway

Collaborator

Centre for Addiction and Mental Health

Collaborator

Source ClinicalTrials.gov
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