Improvement of Memory in Mild Cognitive Impairment

Официальное название

Improvement of Memory in Mild Cognitive Impairment (MCI) Using Transcranial Alternating Current Stimulation (tACS) Guided by EEG and MRI: a Randomized, Sham-controlled, Parallel-arm, Double-blind Study

Обзор

The Clinical Trial will systematically examine the feasibility of remote, caregiver-led tACS for older adults with memory deficits and evaluate whether repeated tACS leads to sustained improvement of neuronal activity and memory functions.

Подробное описание

The proposed investigation will systematically examine the feasibility and efficacy of remote, caregiver-led tACS for older adults with memory decline. This study will provide data to support the safety and effectiveness of home-based tACS in this population and will lead to future research to increase access to tACS as a part of memory decline prevention and treatment for older adults.

Вмешательства

• Устройство transcranial alternating current stimulation (tACS)
  tACS will be delivered by a battery-driven current stimulator Starstim SS32 (Neuroelectrics) through surface Ag/AgCl electrodes placed into holes of a neoprene cap corresponding to the international 10/20 EEG system. Gel (Parker Lab, Inc.) will be applied to optimize signal conductivity and lower impedance. Two tACS (active and sham) conditions will be applied in randomized order. 40 Hz tACS will be delivered to different brain areas of the memory network. We will employ a multielectrode montage
• Устройство high-density electroencephalography (hdEEG)
  EEG will be recorded with a 257-channel EEG system. An EEG net is applied at once on the head with evenly spaced sensors that provide full scalp coverage, including the cheek. The net contains Ag/Ag-Cl electrodes that are interconnected by thin rubber bands and contain small sponges soaked with saline water that touch the participant's scalp surface directly. Net application takes about 10 min to derive to impedances of \<30 kOhms. EEG is recorded with 1 kHz and band-pass filtered between DC-200
• Диагностический тест Montreal Cognitive Assessment (MoCA)
  Clinical Evaluation and Cognitive Assessment - to characterize the level of dementia and changes in cognitive status measured at the baseline and after 4 weeks of gamma/sham tACS intervention, and in a follow-up 3 months after the stimulation using MoCA.

Первичные конечные точки

• cognitive status measured by Montreal Cognitive Assessment (MoCA) [Срок оценки: baseline, after 4 weeks]

Вторичные конечные точки (1)

• modulation of gamma activity assessed with high-density EEG [Срок оценки: baseline, after 4 weeks,]

Критерии участия

Критерии включения

Mild Cognitive Impairment (MCI) patients

• age ≥ 55 years old
• clinical diagnosis of mild cognitive impairment (MCI) based on a comprehensive clinical assessment and standard neuropsychological examination including tests of language, visuospatial thinking, executive functions, and memory
• confirmation of diagnosis will be made by Prof. Paul Unschuld, the study MD, based on a participant's cognitive evaluation and history
• understanding of the informed consent
• able and willing to comply with all study requirements
• informed consent form was signed
• women of childbearing potential (WOCBP) must perform a pregnancy test during screening

Caregiver

• minimum 21 years of age
• self-reported computer/tablet proficiency
• willingness to learn how to use tACS
• availability during the study period to administer tACS to the participant
• informed consent form was signed
• women of childbearing potential (WOCBP) must perform a pregnancy test during screening

Критерии исключения

Mild Cognitive Impairment (MCI) patients

• age < 55 years old
• any current diagnosis of a psychiatric disorder (e.g., schizophrenia, bipolar disorder, depressive disorder)
• other than MCI, any history of other progressive or genetic neurologic disorder (e.g., Parkinson's disease, multiple sclerosis, tubular sclerosis) or acquired neurological disease (e.g., stroke, traumatic brain injury, tumor), including intracranial lesions
• history of head trauma resulting in prolonged loss of consciousness
• current history of poorly controlled headaches including chronic medication for migraine prevention
• history of fainting spells of unknown or undetermined etiology that might constitute seizures
• history of seizures, diagnosis of epilepsy
• any unstable medical condition or chronic uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
• contraindication for undergoing MRI or receiving tACS
• any metal in the brain or skull (excluding dental fillings) or elsewhere in the body unless cleared by the responsible covering MD (e.g., MRI compatible joint replacement)
• any skin problems, such as dermatitis, psoriasis, or eczema
• any electrically, magnetically, or mechanically activated implanted devices such as a pacemaker, intracranial electrodes, implanted defibrillators, medication pumps, nerve stimulators, vascular clips, or any other prosthesis in the brain
• any serious life-threatening disease such as congestive heart failure, pulmonary obstructive chronic disease, or active neoplasia
• pregnant women
• adults lacking capacity for consent

Caregiver

• insufficient understanding of study procedures
• poor eyesight, severe arthritis in the hands, pain, deformity or other condition that interferes with successful administration of tACS

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• University of Geneva, Campus Biotech — Geneva

Публикации

• Brechet L, Brunet D, Birot G, Gruetter R, Michel CM, Jorge J. Capturing the spatiotemporal dynamics of self-generated, task-initiated thoughts with EEG and fMRI. Neuroimage. 2019 Jul 1;194:82-92. doi: 10.1016/j.neuroimage.2019.03.029. Epub 2019 Mar 19. PMID 30902640
• Brechet L, Michel CM, Schacter DL, Pascual-Leone A. Improving autobiographical memory in Alzheimer's disease by transcranial alternating current stimulation. Curr Opin Behav Sci. 2021 Aug;40:64-71. doi: 10.1016/j.cobeha.2021.01.003. Epub 2021 Feb 14. PMID 34485630
• Brechet L, Yu W, Biagi MC, Ruffini G, Gagnon M, Manor B, Pascual-Leone A. Patient-Tailored, Home-Based Non-invasive Brain Stimulation for Memory Deficits in Dementia Due to Alzheimer's Disease. Front Neurol. 2021 May 20;12:598135. doi: 10.3389/fneur.2021.598135. eCollection 2021. PMID 34093384
• Benussi A, Cantoni V, Grassi M, Brechet L, Michel CM, Datta A, Thomas C, Gazzina S, Cotelli MS, Bianchi M, Premi E, Gadola Y, Cotelli M, Pengo M, Perrone F, Scolaro M, Archetti S, Solje E, Padovani A, Pascual-Leone A, Borroni B. Increasing Brain Gamma Activity Improves Episodic Memory and Restores Cholinergic Dysfunction in Alzheimer's Disease. Ann Neurol. 2022 Aug;92(2):322-334. doi: 10.1002/ana. PMID 35607946
• Bouhour C, Konstantopoulou S, Piton T, Tingaud M, Mauriello C, Lory K, Unschuld PG, Brechet L. Family caregiver perspectives on administering home-based stimulation in patients with mild cognitive impairment. J Alzheimers Dis. 2026 May;111(1):249-257. doi: 10.1177/13872877261429857. Epub 2026 Mar 15. PMID 41834385

Идентификаторы

NCT: NCT05708001 · 2021-D0055

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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