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Идёт набор NCT06733714

Association of Transcranial Alternating Current Stimulation with Digital Cognitive Training for Cognitive Remediation in Older Adults

Без фазы С лечением Cognitive Dysfunction Alzheimer Disease Mild Cognitive Impairment Cognitive Decline

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Transcranial Alternating Current Stimulation, Digital Cognitive Training.
Кому может быть актуально
Состояния в реестре: Cognitive Dysfunction, Alzheimer Disease, Mild Cognitive Impairment, Cognitive Decline. Базовые параметры: от 50 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бразилия
Следующий шаг
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Обзор

BACKGROUND Cognitive decline in older adults, especially those who develop Mild Cognitive Impairment and Alzheimer's Disease, currently has limited options of pharmacological treatments, with modest efficacy. Digital Cognitive Training (DCT) and Transcranial Alternating Current Stimulation (tACS) are two promising tools for cognitive remediation in this population. In this exploratory study, we investigate feasibility, tolerability and preliminary effects of the association of both interventions in older adults with cognitive complaints. METHODS Older adults with cognitive complaints are being enrolled for this study, which comprises 5 daily sessions of 30 minutes of DCT using the BrainHQ platform while simultaneously receiving theta tACS (6Hz, 1.6mA) targeting the Left Dorsolateral Prefrontal Cortex.

Подробное описание

Our goals in this study are:

* To investigate the feasibility and safety of transcranial direct current stimulation (tDCS) adjunctive to cognitive training (CT) in a cohort of individuals diagnosed with mild cognitive impairment (MCI), Subjective Cognitive Decline or Alzheimer's desease in it's initial phase (CDR 1). * To assess the efficacy of this combined intervention in modulating cognitive function, as measured by a comprehensive neuropsychological battery. * To explore the underlying neural mechanisms of this intervention by examining changes in event-related potentials (ERPs), specifically the N200 and P300 components, which are sensitive to cognitive processes and neural plasticity. * To identify potential peripheral biomarkers in serum that may correlate with cognitive decline and response to the intervention. * To determine whether the combined intervention can induce lasting changes in neurophysiological markers, as assessed by repeated ERP measurements. * To examine the relationship between the observed cognitive improvements, alterations in neurophysiological measures, and changes in serum biomarker levels, with the aim of elucidating the biological mechanisms underlying the intervention's effects.

Вмешательства

  • Устройство Transcranial Alternating Current Stimulation
    An alternate eletric current of 1.6mA in theta frequency is applied in the scalp, using two eletrodes (5x5cm). The eletrodes are located aiming for the left dorsolateral prefrontal Cortex area.
  • Устройство Digital Cognitive Training
    Using a tablet, the participant will do exercises that were designed to stimulate cognitive domains, especially attention and memory. In this case, we use the BrainHQ platform.

Первичные конечные точки

  • MONTREAL COGNITIVE ASSESSMENT (MOCA) [Срок оценки: 1 week after intervention]
Вторичные конечные точки (11)
  • Five digits test (FDT) [Срок оценки: 1 week after intervention]
  • Rey-Osterrieth complex figure (ROCF) [Срок оценки: 1 week after intervention]
  • Semantic and phonemic verbal fluency [Срок оценки: 1 week after intervention]
  • The Rey Auditory Verbal Learning Test (RAVLT) [Срок оценки: 1 week after intervention]
  • Visual P300 (Event-Related Potential) [Срок оценки: 1 week after intervention]
  • Serum GFAP Analysis [Срок оценки: before intervention]
  • Serum Beta-Amyloid Analysis [Срок оценки: before intervention]
  • Serum Tau Protein Analysis [Срок оценки: before intervention]
  • Prosaccade Task (Eye Tracking) [Срок оценки: 1 week after intervention]
  • Antisaccade Task (Eye Tracking) [Срок оценки: 1 week after intervention]
  • Visual Search Task (Eye Tracking): [Срок оценки: 1 week after intervention]

Критерии участия

Критерии включения

  • Healthy subjects over 50 years old, with cognitive complaints

Критерии исключения

  • Estimated Intelligence Quotient <80
  • Dependence on psychoactive substances (DSM-V)
  • Severe psychiatric or neurological disorders
  • Uncorrected visual/hearing problems
  • History of syncope for an unexplained reason or seizure less than a year ago
  • Previous stroke
  • Use of anticoagulants
  • Intracranial metallic prosthesis or cardiac pacemaker
  • Any contraindication to performing 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

Бразилия · 1 центр
  • Clínica da Memória - IPUB / UFRJ — Rio de Janeiro

Идентификаторы

NCT: NCT06733714 · 38114820.3.0000.5263

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗