Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2023-11-15
2026-11-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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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.
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.
Cognitive Training
Cognitive training will be conducted using the BrainHQ software program.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
55 Years
70 Years
ALL
No
Sponsors
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Brainsway
INDUSTRY
Centre for Addiction and Mental Health
OTHER
Rotman Research Institute at Baycrest
OTHER
Responsible Party
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Linda Mah, MD
Clinician Scientist
Principal Investigators
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Linda Mah
Role: PRINCIPAL_INVESTIGATOR
Baycrest Rotman Research Institute
Locations
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Rotman Research Institute at Baycrest
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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21-01
Identifier Type: -
Identifier Source: org_study_id
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