Longitudinal Study to Investigate Different Transcranial Electrical Stimulation

Официальное название

Longitudinal Study to Investigate Different Treatment Protocols of Transcranial Electrical Stimulation for Individuals With Dementia

Обзор

This research investigates the effect of different frequencies of tACS (0 Hz, 30 Hz, 50 Hz, 70 Hz, 90 Hz) and tRNS with cognitive exercises in a regimen protocol of 4 weeks, everyday (Monday to Friday). The study design is a longitudinal study design in which participants receive different tES randomly ordered. Treatments occur for 4 weeks, then 12 weeks of no treatment (wash-out period), repeated for each tES treatment type. Participants have the option of having their choice of music in the background while they perform cognitive exercises.

Подробное описание

This research will investigate the effect of applying transcranial electrical stimulation (tES) with different parameters when paired with cognitive exercises with optional background music on older adults in a longitudinal study. In addition, the researchers will investigate and explore novel technological methods not only to monitor the plausible changes due to intervention. Since most technological interventions on dementia have a demanding and costly protocol, it would be of great interest to personalized optimum treatment strategy. The investigators will use Egocentric Spatial Assessment using our Virtual Reality Navigation (VRN) and functional near infrared spectroscopy (fNIRS) measurements and analysis to develop the monitoring technologies. VRN measures how people orient themselves in a non-familiar environment; the investigators hypothesize that it is deteriorated significantly in Alzheimer's disease even at its onset. fNIRS measures oxygenated and deoxygenated blood flow to the brain and it may help to understand neuronal changes due to intervention.

Вмешательства

• Устройство Transcranial Direct Current Stimulation (tDCS)
  A light electrical current with zero frequency (tDCS) will be applied to the scalp of the participants via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. They have the option of having their choice of music playing in the background while they perform the cognitive exercises. Cognitive exercises: Participants will perform memory and learning games/tasks through the "Mind Triggers" app on an IPad and other cognitive games. Part
• Устройство 30 Hz Transcranial Alternating Current Stimulation (tACS)
  A light electrical current with 30 Hz frequency (tACS) will be applied to the scalp of the participants via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. They have the option of having their choice of music playing in the background while they perform the cognitive exercises. Cognitive exercises: Participants will perform memory and learning games/tasks through the "Mind Triggers" app on an IPad and other cognitive games. Par
• Устройство 50 Hz Transcranial Alternating Current Stimulation (tACS)
  A light electrical current with 50 Hz frequency (tACS) will be applied to the scalp of the participants via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. They have the option of having their choice of music playing in the background while they perform the cognitive exercises. Cognitive exercises: Participants will perform memory and learning games/tasks through the "Mind Triggers" app on an IPad and other cognitive games. Par
• Устройство 70 Hz Transcranial Alternating Current Stimulation (tACS)
  A light electrical current with 70 Hz frequency (tACS) will be applied to the scalp of the participants via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. They have the option of having their choice of music playing in the background while they perform the cognitive exercises. Cognitive exercises: Participants will perform memory and learning games/tasks through the "Mind Triggers" app on an IPad and other cognitive games. Par
• Устройство 90 Hz Transcranial Alternating Current Stimulation (tACS)
  A light electrical current with 90 Hz frequency (tACS) will be applied to the scalp of the participants via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. They have the option of having their choice of music playing in the background while they perform the cognitive exercises. Cognitive exercises: Participants will perform memory and learning games/tasks through the "Mind Triggers" app on an IPad and other cognitive games. Par
• Устройство Transcranial Random Noise Stimulation (tRNS)
  A light electrical current with random noise waveform (tRNS) will be applied to the scalp of the participants via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. They have the option of having their choice of music playing in the background while they perform the cognitive exercises. Cognitive exercises: Participants will perform memory and learning games/tasks through "Mind Triggers" app on an IPad and other cognitive games. P

Первичные конечные точки

• Alzheimer's Disease Assessment Scale (ADAS-Cog) [Срок оценки: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)]
• Wechsler Memory Scale (WMS-IV) [Срок оценки: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)]

Вторичные конечные точки (4)

• N-Back [Срок оценки: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)]
• Neuropsychiatric Inventory Questionnaire (NPIQ) [Срок оценки: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)]
• Functional Near Infrared Spectroscopy (fNIRS) [Срок оценки: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)]
• Virtual Reality Navigation (VRN) spatial orientation test [Срок оценки: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)]

Критерии участия

Критерии включения

• ability to read, write and speak English fluently
• MoCA score between 5 and 24

Критерии исключения

• Being diagnosed with Parkinson's disease, Parkinsonian dementia, Huntington disease, speech significant aphasia and intellectual disability, major depression/anxiety, bipolar disorder, schizophrenia or any other major mood disorder.
• Having a history of epileptic seizures or epilepsy
• Inability to adequately communicate in English
• Impaired vision or hearing severe enough to impair performance in cognitive tests
• Current substance abuse disorder
• Currently participating in another therapeutic study for dementia
• Plan to change the medication during any treatment period (5 weeks including the pre-post assessments)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Riverview Health Centre — Winnipeg

Идентификаторы

NCT: NCT06877312 · B2021:089

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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