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Набор по приглашению NCT07145593

Gamma tACS in Attention-Deficit/Hyperactivity Disorder

Без фазы С лечением Attention Deficit Disorder With Hyperactivity (ADHD)

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: Application tACS- 80 Hz, Application tACS -40 Hz, Application TACS - (6-80 Hz), Application TACS- Individual Gamma Hz.
Кому может быть актуально
Состояния в реестре: Attention Deficit Disorder With Hyperactivity (ADHD). Базовые параметры: 18 лет — 40 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
Turkey (Türkiye)
Следующий шаг
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Официальное название

Gamma Transcranial Alternating Current Stimulation in Attention Deficit Hyperactivity Disorder

Обзор

Attention-Deficit/Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder characterized by symptoms of inattention, impulsivity, and hyperactivity. These symptoms are often associated with impairments in executive functions and working memory, which are essential for goal-directed behavior and cognitive control. Deficits in these domains can significantly hinder individuals' academic, social, and daily functioning. Gamma oscillations (30-80 Hz) play a crucial role in cognitive integration, attention, and memory processes, and are thought to emerge from the balance between excitatory and inhibitory neuronal activity. Transcranial Alternating Current Stimulation (tACS) is a non-invasive brain stimulation technique that modulates neuronal activity through rhythmic electrical currents. Recent studies suggest that gamma-frequency tACS applied to the prefrontal cortex can enhance cognitive performance and attentional processes. In individuals with ADHD, disrupted gamma connectivity and reduced regional gamma power have been associated with attentional deficits. Therefore, gamma tACS may modulate both regional activity and long-range functional connectivity, offering a promising neuromodulation strategy to alleviate ADHD symptoms. In this context, the present study aims to investigate the effects of bilateral gamma-frequency tACS applied to the prefrontal cortex on attention and executive function performance in individuals with ADHD. Changes in gamma oscillatory activity will be measured using EEG to assess the neurophysiological impacts of stimulation. The study seeks to evaluate whether gamma tACS can serve as a targeted, evidence-based intervention to address the neurofunctional deficits observed in ADHD, potentially offering a novel therapeutic approach.

Вмешательства

  • Устройство Application tACS- 80 Hz
    In this study, a single 20-minute session of tACS will be administered over the bilateral dorsolateral prefrontal cortex (DLPFC) at various gamma frequencies (80 Hz).The anodal surface electrode will be placed over the left DLPFC (F3 according to the 10-20 system), and the cathodal electrode over the right DLPFC (F4).
  • Устройство Application tACS -40 Hz
    In this study, a single 20-minute session of tACS will be administered over the bilateral dorsolateral prefrontal cortex (DLPFC) at gamma frequencies (40 Hz). The anodal surface electrode will be placed over the left DLPFC (F3 according to the 10-20 system), and the cathodal electrode over the right DLPFC (F4).
  • Устройство Application TACS - (6-80 Hz)
    In this study, a single 20-minute session of tACS will be administered over the bilateral dorsolateral prefrontal cortex (DLPFC) at theta- gamma coupling frequencies ( 6-80 Hz). The anodal surface electrode will be placed over the left DLPFC (F3 according to the 10-20 system), and the cathodal electrode over the right DLPFC (F4).
  • Устройство Application TACS- Individual Gamma Hz
    In this study, a single 20-minute session of tACS will be administered over the bilateral dorsolateral prefrontal cortex (DLPFC) at individual gamma frequencies . The anodal surface electrode will be placed over the left DLPFC (F3 according to the 10-20 system), and the cathodal electrode over the right DLPFC (F4).
  • Устройство Application TACS- Sham
    In this study, a single 20-min tACS session will be applied over the bilateral dorsolateral prefrontal cortex (DLPFC) in a sham application. The anodal surface electrode will be placed over the left DLPFC (F3 of the 10-20 system) and the cathodal electrode will be placed over the right DLPFC (F4).

Первичные конечные точки

  • Öktem Verbal Memory Test [Срок оценки: Pre-tACS Baseline (prior to stimulation) / Post-tACS (within 30 minutes after stimulation)]
  • Forward and Backward Digit Span [Срок оценки: Pre-tACS Baseline (prior to stimulation) / Post-tACS (within 30 minutes after stimulation)]
  • Verbal fluency tests [Срок оценки: Pre-tACS Baseline (prior to stimulation) / Post-tACS (within 30 minutes after stimulation)]
  • Resting State EEG and TASK EEG [Срок оценки: Pre-tACS Baseline (prior to stimulation) / Post-tACS (within 30 minutes after stimulation)]

Критерии участия

Критерии включения

  • Being between 18 and 40 years of age
  • Receiving an ADHD diagnosis
  • Scoring above 25 on the Montreal Cognitive Assessment (MoCA)
  • Being right-handed

Критерии исключения

  • Use of medications with sedative or stimulant effects
  • Presence of metal brain implants or a pacemaker

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Простое слепое
Основная цель
Фундаментальное исследование

Центры проведения

Turkey (Türkiye) · 1 центр
  • Medipol University Istanbul — Istanbul

Идентификаторы

NCT: NCT07145593 · E-10840098-202.3.02-4603

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗