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Идёт набор NCT04206215

Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome

Без фазы С лечением Chronic Pain Carpal Tunnel Syndrome

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: transcranial Direct Current Stimulation (tDCS), Transcranial Ultrasound (TUS).
Кому может быть актуально
Состояния в реестре: Chronic Pain, Carpal Tunnel Syndrome. Базовые параметры: 18 лет — 80 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 purpose of this study is to assess the effects of tDCS in combination with TUS for the treatment of pain in subjects with Carpal Tunnel Syndrome. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation.

Вмешательства

  • Устройство transcranial Direct Current Stimulation (tDCS)
    Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. In the sham group, the tDCS device will not be active for the full 20 minutes.
  • Устройство Transcranial Ultrasound (TUS)
    Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.

Первичные конечные точки

  • Visual Analogue Score (VAS) [Срок оценки: 9 weeks]
Вторичные конечные точки (12)
  • Verbal Rating Scale (VRS) [Срок оценки: Measured for approximately for a total 9 weeks]
  • Visual Analog Mood Scale (VAMS) [Срок оценки: Measured for approximately for a total 9 weeks]
  • Montreal Cognitive Assessment (MOCA) [Срок оценки: Measured for approximately for a total 9 weeks]
  • tDCS Side Effects Questionnaire [Срок оценки: Measured for approximately for a total 9 weeks]
  • Patient Health Questionnaire (PHQ-9) [Срок оценки: Measured for approximately for a total 9 weeks]
  • Multidimensional Pain Inventory (MPI) [Срок оценки: Measured for approximately for a total 9 weeks]
  • Neuropathic Pain Symptom Inventory (NPSI) [Срок оценки: Measured for approximately for a total 9 weeks]
  • Temporal Summation (TS) [Срок оценки: Measured for approximately for a total 9 weeks]
  • Conditioned pain modulation (CPM) [Срок оценки: Measured for approximately for a total 9 weeks]
  • Vibration Detection Threshold (VDT) [Срок оценки: Measured for approximately for a total 9 weeks]
  • Michigan Hand Outcomes Questionnaire (MHQ) [Срок оценки: Measured for approximately for a total 9 weeks]
  • Boston Carpal Tunnel Questionnaire [Срок оценки: Measured for approximately for a total 9 weeks]

Критерии участия

Критерии включения

  • Able to provide informed consent to participate in the study
  • Subjects between 18 to 80 years old
  • Having symptomatic CTS spreading within or beyond the median nerve distribution (demonstrating 'extra-median spread'), involving at least 1 wrist, with chronic pain as defined by International Association for the Study of Pain (existing pain for at least 6 months and having pain on at least half the days in the past 6 months with an average of at least a 3 on a 0-10 VAS scale).
  • Pain resistant to first line therapies of chronic pain (pain still present at lower levels most of the time following therapy)
  • Must have the ability to feel pain as self-reported.

Критерии исключения

  • Subject is pregnant
  • Contraindications to tDCS+TUS:
  • intracranial metal implant
  • implanted brain medical devices
  • History of alcohol or drug abuse within the past 6 months as self-reported
  • Use of carbamazepine within the past 6 months as self-reported
  • Suffering from major depression (with a PHQ-9 score of ≥20)
  • History of neurological disorders involving stroke, brain tumors, or epilepsy with residual neurological symptoms as self-reported (note patients will also be evaluated via EEG at baseline about 1 week prior to stimulation and any patient showing abnormal EEG activity will be removed))
  • History of unexplained fainting spells as self-reported
  • History of head injury resulting in more than a momentary loss of consciousness as self-reported and with current neurological deficits
  • History of intracranial neurosurgery as self-reported

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
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Spaulding Rehabilitation Network Research Institute — Charlestown

Идентификаторы

NCT: NCT04206215 · 2019P002804

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗