dTMS for Subjective Cognitive Decline

Официальное название

Effect of Deep Transcranial Magnetic Stimulation (dTMS) on Cognition in Older Adults With Subjective Cognitive Decline (SCD)

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.
• Другое Cognitive Training
  Cognitive training will be conducted using the BrainHQ software program.

Первичные конечные точки

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

Вторичные конечные точки (6)

• Change in baseline memory performance on a neuropsychological battery [Срок оценки: 19 weeks]
• Change in executive function performance on a neuropsychological battery [Срок оценки: 19 weeks]
• Change in baseline in scores on the Geriatric Depression Scale (GDS). [Срок оценки: 19 weeks]
• Change in baseline in scores on the Geriatric Anxiety Inventory (GAI). [Срок оценки: 19 weeks]
• Change in baseline in scores on the Neuropsychiatric Inventory Questionnaire (NPI-Q) [Срок оценки: 19 weeks]
• Change in slow wave and resting state activity [Срок оценки: 17 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Rotman Research Institute at Baycrest — Toronto

Идентификаторы

NCT: NCT06095063 · 21-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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