HD-tDCS in Amyotrophic Lateral Sclerosis: A Multicenter Randomized Controlled Trial
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: Active HD-tDCS, Simulated HD-tDCS.
- Кому может быть актуально
- Состояния в реестре: Amyotrophic Lateral Sclerosis (ALS). 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
- Бразилия, Чили
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
High-Definition Transcranial Direct Current Stimulation (HD-tDCS) in Amyotrophic Lateral Sclerosis: A Multicenter Randomized Controlled Trial
Обзор
Amyotrophic Lateral Sclerosis (ALS) is a nervous system disease that causes muscle weakness and rapidly progresses to the loss of mobility and functionality. Studies suggest that High-Definition Transcranial Direct Current Stimulation (HD-tDCS) is a technique for modulating motor cortical hyperexcitability. However, evidence on the use of HD-tDCS as a neuromodulator of the diaphragmatic motor cortex in people with ALS is inconclusive.
Подробное описание
A multicenter, randomized controlled clinical trial will be conducted. Participants will be randomized into two groups: the HD-tDCS group (gTDCS) and the sham tDCS group (gSham). The intervention protocol will assess the effects of HD-tDCS on respiratory parameters and ALS progression. The study will include individuals of both sexes, aged 18 to 80 years, with a clinical diagnosis of ALS, evaluated before, during, and after the home-based HD-tDCS protocol. The electrodes will be positioned in a circular arrangement over the primary diaphragmatic motor cortex, applying a continuous anodal current intensity. For placebo comparison, only an initial 30-second ramp stimulus will be applied, followed by a minimal current, resulting in no significant intervention. The intervention will be conducted at the participant's home, once daily, five days per week, for two weeks. Patients will undergo evaluations of lung function, cough peak flow, respiratory muscle strength, nasal respiratory pressures, functional capacity, muscle fatigue, cognitive function, as well as surface electromyography of respiratory muscles during active and assisted breathing curves using transcranial magnetic stimulation (TMS), cortical excitability, central tissue oxygenation, respiratory muscle tissue oxygenation, functionality and disease progression, motor control and muscle performance, fatigue and dyspnea, sleep analysis, quality of life, and adverse effects.
Вмешательства
- Устройство Active HD-tDCS
10 sessions of anodal HD-tDCS stimulation (neurostimulator coupled with a 4x1 HD-tDCS multichannel adapter) with a defined electrical current intensity over the cortical representation zone of the left diaphragmatic motor cortex - Устройство Simulated HD-tDCS
10 sessions of sham anodal HD-tDCS stimulation (neurostimulator coupled with a 4x1 HD-tDCS multichannel adapter) over the cortical representation zone of the left diaphragmatic motor cortex. The device will provide a 30-second ramp and then maintain a minimal, non-effective continuous current
Первичные конечные точки
- Cortical excitability assessed via TMS [Срок оценки: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
- Cortical tissue oxygenation [Срок оценки: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
- Electromyographic activity of specific respiratory muscles [Срок оценки: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
Вторичные конечные точки (11)
- Respiratory function assessed by spirometry [Срок оценки: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
- Maximum Inspiratory and Expiratory Pressure [Срок оценки: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
- Cough Peak Flow [Срок оценки: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
- Respiratory muscle oxygenation via near-infrared spectroscopy [Срок оценки: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
- Peripheral upper limb muscle activity assessed via electromyography [Срок оценки: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
- Functionality and disease progression [Срок оценки: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
- Fatigue Severity [Срок оценки: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
- Dyspnea assessed via Modified Borg Scales [Срок оценки: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
- Quality of sleep assessment [Срок оценки: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
- Quality of life assessed using the Brief ALS-specific Quality of Life Questionnaire [Срок оценки: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
- Subjective assessment of stimulation-related effects [Срок оценки: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
Критерии участия
Критерии включения
- Both sexes; diagnosis of ALS according to the revised El Escorial criteria;
- Age between 18 and 80 years;
- Forced Vital Capacity greater than 50% of predicted;
- Sniff nasal inspiratory pressure greater than 40 cmH2O;
- A telephone number to contact the care team and who signed the study consent form.
Критерии исключения
- Subjects who are unable to understand or perform any of the study procedures;
- Subjects who do not agree to participate or voluntarily request withdrawal from the study at any time;
- Subjects with cardiac, respiratory, or musculoskeletal comorbidities;
- Subjects using invasive mechanical ventilation;
- Subjects with a tracheostomy;
- Subjects with a pacemaker;
- Subjects with metallic brain implants or other electronic implants;
- Subjects with a cochlear implant;
- Subjects with epileptic activity or a history of epilepsy, or a family history of epilepsy;
- Subjects with a history of stroke or tumor;
- Subjects prone to severe hemodynamic fluctuations, acute infectious processes, and/or inflammatory conditions;
- Pregnant women at the time of recruitment;
- Subjects who are unable to complete the intervention protocol.
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
Бразилия · 2 центра
- Universidade de Brasília - Campus Ceilândia — Brasília
- PneumoCardioVascular Lab - HUOL/UFRN — Natal
Чили · 2 центра
- Universidad Autónoma de Chile — Santiago
- Universidad do Chile — Santiago
Идентификаторы
NCT: NCT06719947 · HD-tDCSALS · U1111-1306-808