Non-invasive Brain Stimulation and Exercise Intervention for Patients With Motor Neuron Disease

Обзор

Motor neuron disease (MND) is a progressive neurological disorder involving degeneration of motor neurons, leading to muscle weakness, speech and swallowing difficulties, and respiratory failure. This study aims to develop a novel treatment approach combining personalized repetitive transcranial magnetic stimulation (rTMS) with mixed reality (MR) exercise-based games (exergames) to slow disease progression and improve quality of life. In this randomised controlled trial study will compare three groups: (1) rTMS with MR exercise (personalized intervention), (2) rTMS with MR exercise (standard intervention), and (3) sham rTMS with MR exercise. Outcomes will be assessed at baseline, 3 months, and 6 months post intervention. The long-term goal is to implement this approach in clinical settings to enhance care for people with MND.

Подробное описание

After screening process, eligible participants will be invited to visit Chula Neuroscience Center for the baseline assessments which will take proximately 2 hours.

The baseline assessments will be as follow:

1. Demographic information such as age, sex, body height, body weight, body mass index, date of diagnosis, type of MND, and current medications. 2. Questionnaires including amyotrophic lateral sclerosis functional rating scale - revised version (ALSFRS-R), penn upper motor neuron score (PUMNS), patient health questionnaire (PHQ-9), and EuroQol 5-Dimension 5-level (EQ-5D-5L). 3. Clinical assessments including hand grip test, pinch grip test, and hand function. 4. Lung function tests such as forced vital capacity (FVC). 5. Neurophysiological assessment by using transcranial magnetic stimulation (TMS) 6. Electromyography (EMG) including compound muscle action potential (CMAP), motor unit number estimation (MScan fit-MUNE), and motor unit number index (MUNIX). 7. Magnetic resonance imaging (MRI)

Вмешательства

• Устройство Personalized rTMS
  Personalized repetitive transcranial magnetic stimulation (TMS) together with mixed-reality (MR) exercise
• Устройство Standard rTMS
  Standard repetitive transcranial magnetic stimulation (TMS) together with mixed-reality (MR) exercise
• Устройство Sham rTMS
  Sham rTMS together with mixed-reality (MR) exercise

Первичные конечные точки

• Amyotrophic Lateral Sclerosis Functional rating scale - revised version (ALSFRS-R) [Срок оценки: ALSFRS-R will be measured at three time points (baseline, 3-month, and 6-month post intervention).]
• Muscle evoke potential (MEP) [Срок оценки: MEP will be mesured at three time points (baseline, 3-month, and 6-month post intervention).]
• Motor unit number estimation (MScan fit-MUNE) [Срок оценки: MScan fit-MUNE will be mesured at three time points (baseline, 3-month, and 6-month post intervention).]
• Motor unit number index (MUNIX) [Срок оценки: MUNIX will be measured at three time points (baseline, 3-month, and 6-month post intervention).]
• Cortical silent period (CSP) [Срок оценки: Muscle evoke potential will be measured at three time points (baseline, 3-month, and 6-month post intervention).]

Вторичные конечные точки (11)

• Muscle mass [Срок оценки: Muscle mass will be measured at three time points (baseline, 3-month, and 6-month post intervention).]
• Body mass index (BMI) [Срок оценки: BMI will be measured at three time point (baseline, 3-month, 6-month post intervention).]
• Hand grip test [Срок оценки: Hand grip test will be measured at three time points (baseline, 3-month, and 6-month post intervention).]
• Pinch grip test [Срок оценки: Pinch grip test will be measured at three time points (baseline, 3-month, and 6-month post intervention).]
• Hand function [Срок оценки: Hand function will be measured at three time points (baseline, 3-month, and 6-month post intervention).]
• Penn upper motor neuron score (PUMNS) [Срок оценки: PUMNS will be measured at three time points (baseline, 3-month, and 6-month post intervention).]
• Patient health questionnaire (PHQ-9) [Срок оценки: PHQ-9 will be measured at three time points (baseline, 3-month, and 6-month).]
• EuroQol 5-Dimension 5-level (EQ-5D-5L) [Срок оценки: EQ-5D-5L will be measure at three time ponts (baseline, 3-month, and 6-months post intervention).]
• Forced vital capacity (FVC) [Срок оценки: FVC will be measured at three time points (baseline, 3-month, and 6-month post intervention).]
• Magnetic resonance imaging (MRI) [Срок оценки: Brain imaging using MRI will be measured at three time points (baseline, 3-month and 6-month post intervention).]
• Compound muscle action potential (CMAP) [Срок оценки: CMAP will be meausred at three time points (baseline, 3-month, and 6-month post intervention).]

Критерии участия

Критерии включения

• Participants aged between 18 and 80 years
• Diagnosed with any type of motor neuron disease (MND)
• Have mild to moderate severity, as assessed by the Sinaki-Mulder scale, with a severity level between 1 and 3

Критерии исключения

• History of other neurological disorders, such as stroke
• Use of ventilatory support
• Severe dementia

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

Простое слепое

Основная цель

Лечение

Центры проведения

Таиланд · 1 центр

• King Chulalongkorn Memorial hospital, The Thai Red Cross Society — Bangkok

Идентификаторы

NCT: NCT07067229 · COA No. 1142/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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