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Набор скоро начнётся NCT07555379

Bilateral Anodal Cerebellar tDCS for Multidomain Dysfunctions in Patients With Multiple Sclerosis

Без фазы С лечением Multiple Sclerosis

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: Bilateral Cerebellar Transcranial Direct Current Stimulation (ctDCS), Sham Bilateral Cerebellar tDCS.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis. Базовые параметры: от 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
ОАЭ
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Bilateral Anodal Cerebellar tDCS for Multidomain Dysfunctions in Patients With Multiple Sclerosis: A Randomized Controlled Trial Study

Обзор

The goal of this clinical trial is to learn if brain stimulation can improve movement and daily function in people with multiple sclerosis (MS). The study will also look at how this treatment affects fatigue, sleep, memory and attention, and quality of life. The main questions this study aims to answer are the following: Does this treatment improve coordination and balance? Does it reduce fatigue and improve sleep and daily life? Does it change brain activity? Researchers will compare active brain stimulation to sham stimulation (a look-alike treatment that does not deliver real stimulation) to see if the treatment works. Participants will: Receive brain stimulation sessions for two weeks Attend assessment sessions before and after treatment Return for a follow-up visit after four weeks Complete tests of movement, fatigue, sleep, and thinking

Подробное описание

Multiple sclerosis (MS) is a chronic immune-mediated neurological disorder characterized by demyelination and neurodegeneration within the central nervous system. Disruption of cerebro-cerebellar networks is a key feature of MS and contributes to impairments in motor coordination, balance, gait, fatigue, and cognitive performance. Cerebellar involvement is particularly associated with ataxia and postural instability, which significantly affect functional independence and quality of life.

Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique capable of modulating cortical and cerebellar excitability. Previous studies investigating cerebellar tDCS in MS have reported variable findings, which may be related to heterogeneity in stimulation protocols, the predominant use of unilateral stimulation approaches, and the frequent combination of stimulation with task-oriented rehabilitation. These factors limit the ability to isolate the independent effects of neuromodulation.

The cerebellum operates through bilateral cerebro-cerebellar loops, suggesting that bilateral stimulation may provide more comprehensive modulation of these distributed networks compared to unilateral approaches. In addition, the effects of tDCS are influenced by state-dependent factors, including concurrent motor activity. Delivering stimulation as a standalone intervention allows for clearer evaluation of its direct neuromodulatory effects without the confounding influence of concurrent rehabilitation.

This study is designed as a randomized, double-blind, sham-controlled trial to evaluate the effects of bilateral cerebellar tDCS on multidomain dysfunction in individuals with MS. Participants will be randomly assigned to receive either active or sham stimulation. The intervention consists of repeated sessions of bilateral cerebellar stimulation delivered over a two-week period using a standardized protocol.

The study aims to evaluate the effects of this intervention on motor and non-motor domains and to explore associated neurophysiological changes. By isolating the effects of bilateral cerebellar stimulation, this trial seeks to provide a clearer understanding of its therapeutic potential and to inform the development of targeted neuromodulation strategies in MS rehabilitation.

Вмешательства

  • Устройство Bilateral Cerebellar Transcranial Direct Current Stimulation (ctDCS)
    Bilateral cerebellar transcranial direct current stimulation (ctDCS) will be delivered using a constant-current stimulator. Anodal electrodes (5 × 5 cm; 25 cm²) will be positioned bilaterally over the cerebellar hemispheres (approximately 3 cm lateral to the inion), with reference electrodes placed over the buccinator muscles. Stimulation will be applied at 2 mA for 20 minutes per session. Participants will receive five sessions per week for two consecutive weeks (total of 10 sessions).
  • Устройство Sham Bilateral Cerebellar tDCS
    Sham bilateral cerebellar transcranial direct current stimulation (ctDCS) will be delivered using the same electrode placement as the active condition. The current will be ramped up and down at the beginning and end of the session to mimic the sensation of stimulation without delivering continuous current. Each session will last 20 minutes, with five sessions per week for two consecutive weeks (total of 10 sessions).

Первичные конечные точки

  • Scale for the Assessment and Rating of Ataxia (SARA) [Срок оценки: Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after completion of the 10-session intervention), and at 4-week follow-up.]
Вторичные конечные точки (12)
  • The balance evaluation systems test (mini-BESTest) [Срок оценки: Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.]
  • Timed Up and Go (TUG) [Срок оценки: Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.]
  • Six-Minute Walk Test (6MWT) [Срок оценки: Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.]
  • Modified Tardieu Scale (MTS) [Срок оценки: Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.]
  • Modified Fatigue Impact Scale (MFIS) [Срок оценки: Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.]
  • Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.]
  • Multiple Sclerosis Quality of Life-54 (MSQOL-54) [Срок оценки: Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.]
  • Symbol Digit Modalities Test (SDMT) [Срок оценки: Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.]
  • Montreal Cognitive Assessment (MoCA) [Срок оценки: Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.]
  • Resting-State EEG [Срок оценки: Baseline (within 7 days prior to the first intervention session) and immediately post-intervention (within 7 days after the final session).]
  • Motor Evoked Potential (MEP) Amplitude [Срок оценки: Baseline (within 7 days prior to the first intervention session) and immediately post-intervention (within 7 days after the final session).]
  • Resting Motor Threshold (RMT) [Срок оценки: Baseline (within 7 days prior to the first intervention session) and immediately post-intervention (within 7 days after the final session).]

Критерии участия

Критерии включения

  • Confirmed diagnosis of Multiple Sclerosis according to the revised McDonald criteria
  • Adult Age > 18 years
  • Expanded Disability Status Scale (EDSS) score between 2.0 and 6.0
  • Clinically stable disease status for at least 3 months prior to enrollment
  • On stable disease-modifying therapy (DMT) for at least 3 months
  • Ability to understand study procedures and provide informed consent
  • Ability to ambulate independently or with assistive devices sufficient to complete motor assessments

Критерии исключения

  • Multiple sclerosis relapse within the past 3 months
  • History of epilepsy or seizures
  • Presence of implanted electronic devices (e.g., pacemaker, neurostimulator)
  • Metallic implants in the head or skull incompatible with transcranial magnetic stimulation (TMS)
  • Severe cognitive impairment preventing participation in assessments
  • Pregnancy or planned pregnancy during the study period
  • Other neurological or psychiatric disorders that may confound study outcomes
  • Severe musculoskeletal or orthopedic conditions interfering with motor performance testing
  • Contraindications to non-invasive brain stimulation or TMS

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

ОАЭ · 1 центр
  • University of Sharjah — Sharjah city

Идентификаторы

NCT: NCT07555379 · 080412026 · 080422026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗