Deep TMS for Comorbid Depression and Cognitive Impairment in Older Adults

Официальное название

Treatment of Comorbid Depression and Cognitive Impairment in Older Adults With Neurocognitive Disorders Using Deep Transcranial Magnetic Stimulation (dTMS)

Обзор

In this study, the investigators will be examining the effects of the deep repetitive transcranial magnetic stimulation (rTMS) using the H1 coil in patients over the age of 60 diagnosed with mild to early-moderate Alzheimer's disease (AD) or mild cognitive impairment (MCI) and comorbid Major Depressive Disorder (MDD) who have been unable to tolerate or failed to respond to antidepressant medications. The coil was designed to stimulate deeper regions of the left dorsolateral prefrontal cortex (DLPFC). Based on prior research, the investigators propose that active stimulation with the H1 coil for 4 weeks may result in significant remission rates and will be tolerable and safe.

Подробное описание

This study is an open-label trial to evaluate the safety and efficacy of H1-coil dTMS in treating depression in MCI and mild AD patients over 60 years of age who have not tolerated or failed to respond to antidepressant medications. 28 patients will be assigned to receive 4 consecutive weeks of daily active dTMS treatment. The long-term effects of treatment on emotional cognitive measures will be assessed at a 4-week follow-up visit (8 weeks from baseline). Symptom change and remission criteria will be assessed using the Montogmery-Asberg Depression Rating Scale (MADRS). Cognition will be assessed using a validated neuropsychological battery.

We will also offer patients to receive 4 weeks of treatment using theta-burst TMS, which is a milder version of TMS.

Вмешательства

• Устройство Brainsway H1-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.

Первичные конечные точки

• Change From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) [Срок оценки: 4 weeks]

Вторичные конечные точки (7)

• Remission Rates Compared Within Treatment Group [Срок оценки: 4 weeks]
• Response Rates Compared Within Treatment Group [Срок оценки: 4 weeks]
• Change From Baseline on the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [Срок оценки: 4 weeks]
• Change From Baseline on the Neuropsychological Battery [Срок оценки: 4 weeks]
• Change in Functional Connectivity between PFC and Limbic Regions [Срок оценки: 4 weeks]
• Change in Perfusion within Prefrontal Cortex (PFC) and Posterior Cingulate Cortex (PCC) [Срок оценки: 4 weeks]
• Change in frontal theta power within the Anterior Cingulate Cortex (ACC) [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• meet DSM 5 criteria for Major or Mild Neurocognitive Disorder due to Alzheimer's disease with Clinical Dementia Rating Scale (CDR) score of at least 0.5
• have been diagnosed with DSM5 Major Depressive Disorder, with the current episode longer than 4 weeks but less than 5 years
• did not respond to or did not tolerate antidepressant treatment
• 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 disease or history of stroke
• Modified Hachinski Score (MHIS) > 3 (to exclude those with significant vascular component to memory loss)
• have 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
• are taking psychotropic medications including antidepressant medications, antipsychotics or mood stabilizing medications due to increased risk of seizure
• are taking memantine
• have a history of abnormal MRI of the brain
• have significant hearing loss requiring use of hearing aids
• have untreated hypo- or hyper-thyroidism

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Rotman Research Institute at Baycrest — Toronto

Публикации

• Hodzic-Santor BH, Meltzer JA, Verhoeff NPLG, Blumberger DM, Mah L. Safety, tolerability, and feasibility of deep transcranial magnetic stimulation for late-life depression with comorbid major or mild neurocognitive disorder. Int Psychogeriatr. 2021 Jan;33(1):99-101. doi: 10.1017/S1041610220003543. Epub 2020 Nov 6. No abstract available. PMID 33153503

Идентификаторы

NCT: NCT03665831 · CICP-2-00095

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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