Меню
Набор скоро начнётся NCT06438666

Effects Obtained at Manual Function After Applying Anodic Transcranial Direct Current Stimulation (tCDS) in Children With Spastic Hemiparetic Cerebral Palsy

Без фазы С лечением Hemiparetic Cerebral Palsy

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: Anodic Transcranial Direct Current Stimulation.
Кому может быть актуально
Состояния в реестре: Hemiparetic Cerebral Palsy. Базовые параметры: 14 лет — 18 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
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Quasi Experimental Study About the Effects Obtained at Manual Function After Applying Anodic Transcranial Direct Current Stimulation in Children With Spastic Hemiparetic Cerebral Palsy

Обзор

Spastic Hemiparetic Cerebral Palsy (SHCP) uses to limit the manual function. Using anodic transcranial direct current stimulation, it is possible to activate certain cerebral areas depending on where the electrodes are. This study will use this kind of stimulation on the contralateral primary motor cortex of the affected upper limb and analyze the effects.

Подробное описание

It has been designed a single-arm prospective longitudinal quasi-experimental pilot clinical study following the SPIRIT 2013 statement. It will value the time that the children spend doing the bimanual activities described by the Children's Hand-Use Experience Questionnaire (CHEQ), it will also value the subjective experience doing those activities; it will analyze the active movement (Fugl-Meyer for upper limb), spasticity (modified Ashworth), manual strength (dynamometry) and the recruitment improvement (surface electromyography) too.

This study will apply the anodic transcranial direct current stimulation over 20 children between 14-18 years old. The protocol that it will follow is the next one: 3 days to value the outcome measures, 4 days (1 session per day of 17 minutes and 30 seconds) to apply the protocol of anodic transcranial direct current stimulation (0,6 mA of intensity). It will use the EPTE V07 Bipolar System by IONCLINICS ®; 3 days to value the outcome measures studying the effects produced at the affected upper limb. Another evaluation will be realized 3 weeks after the last session of anodic transcranial direct current stimulation to know if the effects obtained last at medium-long term.

Вмешательства

  • Устройство Anodic Transcranial Direct Current Stimulation
    This study will apply the anodic transcranial direct current stimulation over 20 children between 14-18 years old. The protocol that it will follow is the next one: 3 days to value the outcome measures, 4 days (1 sessions per day of 17 minutes and 30 seconds) to apply the protocol of anodic transcranial direct current stimulation (0,6 mA of intensity). It will use the EPTE V07 Bipolar System by IONCLINICS ®; 3 days to value the outcome measures studying the effects produced at the affected upper

Первичные конечные точки

  • Changes in the timing that children use to complete the 29 items of the Children's Hand-Use Experience Questionnaire (CHEQ). [Срок оценки: Baseline, after 4 days (after de foruth sessions planned) and 3 weeks later]
Вторичные конечные точки (4)
  • Changes at the spasticity [Срок оценки: Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later]
  • Changes at the active movement [Срок оценки: Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later]
  • Changes at the manual strength [Срок оценки: Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later]
  • Changes at the recruitment of the motor units. [Срок оценки: Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later]

Критерии участия

Критерии включения

  • Children between 14-18 years old.
  • Children with spastic hemiparetic cerebral palsy diagnosis.
  • Children with a cognitive level high enough to understand and to do the activities to value them.
  • Children hemodynamically stable.
  • Children forming part of levels II-IV of the Manual Ability Classification System (MACS).

Критерии исключения

  • Children with defibrillator.
  • Children with pacemaker.
  • Children with cerebral stimulator.
  • Children with intracranial metallic implants.
  • Children with opened cranial after clambering.
  • Children that receive another treatment (pharmacological or physiotherapical) that could interfere or disrupt the results.
  • Another circumstance where the electrotherapy treatment is contraindicated.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Rocío Martín Valero — Málaga

Идентификаторы

NCT: NCT06438666 · tDCS_2024UMA

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗