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Идёт набор NCT05354232

Home-based Transcranial Direct Current Stimulation (tDCS) for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)

Без фазы С лечением Attention Deficit Disorder Attention Deficit Disorder With Hyperactivity

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: 2 mA transcranial direct current stimulation (tDCS), 1 mA transcranial direct current stimulation (tDCS), Sham transcranial direct current stimulation (tDCS).
Кому может быть актуально
Состояния в реестре: Attention Deficit Disorder, Attention Deficit Disorder With Hyperactivity. Базовые параметры: 18 лет — 65 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
США
Следующий шаг
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Обзор

The investigators are investigating whether home-based tDCS over the course of four weeks can improve ADHD symptom severity and improve dysexecutive functioning (cognitive control). Further, the investigators are investigating whether there is a dose-dependent response to tDCS.

Подробное описание

This mechanistic clinical trial will be the first of its kind to assess the clinical and cognitive efficacy of tDCS, and its relationship to physiological target engagement. It will also provide critical knowledge about tDCS dosing in a therapeutic context (i.e. 30 days of daily tDCS). Last, it will assess the feasibility and acceptability of home-based neuromodulation therapies for ADHD, reducing the most significant obstacle for the implementation of devices therapies (i.e. daily visits to the hospital for several weeks) and facilitating access to advanced therapeutics to a large population of patients with ADHD. An additional goal of the proposed study is to assess the feasibility and acceptability of home-based neuromodulation therapies for ADHD, reducing the most significant obstacle for the implementation of devices therapies (i.e. daily visits to the hospital for several weeks) and facilitating access to advanced therapeutics to a large population of patients with ADHD.

Вмешательства

  • Устройство 2 mA transcranial direct current stimulation (tDCS)
    tDCS is a non-invasive neuromodulatory technique that has previously demonstrated the ability to transiently modulate cognitive domains in both healthy and psychiatric populations. In the 2mA condition, the investigators will assist the administration of a 2mA current stimulation from the device.
  • Устройство 1 mA transcranial direct current stimulation (tDCS)
    tDCS is a non-invasive neuromodulatory technique that has previously demonstrated the ability to transiently modulate cognitive domains in both healthy and psychiatric populations. In the 1mA condition, the investigators will assist the administration of a 1mA current stimulation from the device.
  • Устройство Sham transcranial direct current stimulation (tDCS)
    tDCS is a non-invasive neuromodulatory technique that has previously demonstrated the ability to transiently modulate cognitive domains in both healthy and psychiatric populations. In the sham condition, the investigators will assist the administration of a sham stimulation from the device.

Первичные конечные точки

  • P300 Amplitude during Erickson Flanker Task [Срок оценки: Week 1 - Week 8 of Study]
  • Global Assessment of Functioning (GAF) Scale [Срок оценки: Week 1 - Week 8 of Study]
  • Adult ADHD Self-Report Scale [Срок оценки: Week 1 - Week 8 of Study]

Критерии участия

Критерии включения

  • Male and female outpatients 18-65 years of age
  • A diagnosis of ADD/ADHD or meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.

Критерии исключения

  • Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.
  • Active substance dependence (except for tobacco).
  • Pregnant or nursing females.
  • Inability to participate in testing procedures.
  • Premorbid neurological conditions (including neurovascular and neurodegenerative diseases such as traumatic brain injury, stroke, Parkinson's, AD and other dementias) and severe psychiatric disorders (bipolar disorder, schizophrenia).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Massachusetts General Hospital — Charlestown

Публикации

  • Dubreuil-Vall L, Ruffini G, Camprodon JA. Deep Learning Convolutional Neural Networks Discriminate Adult ADHD From Healthy Individuals on the Basis of Event-Related Spectral EEG. Front Neurosci. 2020 Apr 9;14:251. doi: 10.3389/fnins.2020.00251. eCollection 2020. PMID 32327965

Идентификаторы

NCT: NCT05354232 · 2022P000362

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗