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临床试验/NCT07145593
NCT07145593Enrolling By Invitation不适用

Gamma Transcranial Alternating Current Stimulation in Attention Deficit Hyperactivity Disorder

Medipol University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
60
试验地点
1
主要终点
Öktem Verbal Memory Test

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Öktem Verbal Memory Test

时间窗: Pre-tACS Baseline (prior to stimulation) / Post-tACS (within 30 minutes after stimulation)

Öktem Verbal Memory Test is a test of verbal memory processes, developed and validated by Öktem in 1992. It is designed to measure various variables related to memory.

Forward and Backward Digit Span

时间窗: Pre-tACS Baseline (prior to stimulation) / Post-tACS (within 30 minutes after stimulation)

This test, which is a subtest of the Wechsler Memory Scale, was developed to assess overall attention. It consists of two stages. The first stage evaluates the forward digit span, composed of random sequences ranging from 2 to 8 digits. In the second stage, the backward digit span is assessed using random sequences of 2 to 7 digits. In the first stage, numbers are read aloud with one-second intervals, and participants are expected to repeat the sequences exactly as presented. In the second stage, numbers are again read with one-second intervals, but participants are required to repeat the digits in reverse order. The test is terminated if the participant makes consecutive errors. The forward digit span assesses sustained attention, while the backward span also evaluates working memory performance.

Verbal fluency tests

时间窗: Pre-tACS Baseline (prior to stimulation) / Post-tACS (within 30 minutes after stimulation)

Verbal fluency tests measure the ability to generate words within a specific category over a limited time period. Verbal fluency performance has been associated not only with general language skills and semantic memory functions but also with executive functions such as attention, working memory, and processing speed. In this study, semantic and phonemic fluency tasks will be used.

Resting State EEG and TASK EEG

时间窗: Pre-tACS Baseline (prior to stimulation) / Post-tACS (within 30 minutes after stimulation)

The EEG recordings of the participants will be conducted using a BrainAmp 64-channel DC system. A 64-channel EasyCap will be used. AFz will serve as the ground electrode, and FCz will be used as the reference electrode. Impedance values will be maintained below 10 kOhm. EEG data will be recorded using the BrainVision Recorder software (Brain Products, Munich, Germany) with a band-pass filter set between 0.01 and 250 Hz.A 4-minute eyes-open and a 4-minute eyes-closed resting-state EEG recording will be conducted. EEG will also be recorded during the 2-back task and the memory task. 2-back Task: A visual n-back task will be administered to assess working memory. The task load will consist of 8-minute sessions. Memory Task: The memory task, which involves both encoding and retrieval of episodic information, will be examined using a visual memory paradigm presented to the participants.

次要结局

未报告次要终点

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

FATMA AYDIN

Principal Investigator

Medipol University

研究点 (1)

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