Cognitive and Electrophysiological Assessment of Non-Invasive Temporally-Interfering Electric Fields Stimulation (TIEFS)

Обзор

The goal of this clinical trial is to learn how a non-invasive brain stimulation method called Temporally Interfering Electric Fields Stimulation (TIEFS) affects brain activity and thinking in adults. TIEFS uses electrical currents applied to the scalp to influence brain activity without surgery. The main questions this study aims to answer are: * How does TIEFS change brain signals measured with brain recordings? * Does TIEFS affect thinking abilities such as memory, language, movement, or perception? * Is TIEFS safe and well tolerated when used in people? This study includes two groups of participants. One group includes adults with epilepsy who are already undergoing specialized brain monitoring as part of their medical care. The other group includes healthy adults with no history of seizures. Participants will: * Receive brief sessions of TIEFS using electrodes placed on the scalp * Complete computer-based tasks that test memory, attention, language, or movement. Answer questions about how the stimulation feels * Have brain activity recorded during the study Each study visit lasts up to three hours and may occur in one or two sessions. Information from this study may help researchers better understand the human brain and support the development of future non-invasive brain stimulation treatments.

Вмешательства

• Устройство Temporal Interference Electrical Stimulation
  Temporal Interference Electrical Stimulation (TIEFS) is a non-invasive brain stimulation technique that uses two high-frequency electrical fields (\>1 kHz) to generate an interference pattern at a specific brain region, creating a low-frequency envelope (Δf = f2 - f1) at the target depth. Unlike traditional stimulation methods, which affect only superficial brain regions, TIEFS can reach deeper structures without the need for implanted electrodes. The stimulation is applied through scalp electro

Первичные конечные точки

• Brain activity changes during Stimulation [Срок оценки: Measurements will be recorded throughout the stimulation session (lasting up to 90 minutes), with data collected before, during, and immediately after each stimulation.]

Критерии участия

Критерии включения

• Adult patients (age 18-65 years of age) undergoing an intracerebral electrophysiology study for epilepsy pre-surgical evaluation are eligible for inclusion.
• For healthy control subjects are also eligible for inclusion (Scalp EEG measurements).
• Participants must be able to sufficiently speak and understand English or Spanish for consent and be able to understand and complete cognitive tasks.
• All subjects must have the ability to give valid informed consent.

Критерии исключения

• No pregnant women will be recruited.
• People with implanted electrical devices such as Deep Brain Stimulation devices or Pacemakers.
• No prisoners will be recruited.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• University of California Davis Medical Center — Sacramento

Идентификаторы

NCT: NCT07663578 · 2226959

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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