Effects of EXOPULSE Mollii Suit on Spasticity and Functionality in Multiple Sclerosis Patients

Официальное название

Investigating the Effects of the EXOPULSE Mollii Suit on Spasticity and Functionality in Patients With Multiple Sclerosis

Обзор

Spasticity affects \>80% of MS patients, with 35-54% experiencing moderate-to-severe symptoms, impairing mobility and sleep. Electrical stimulation parameters (e.g., high vs. low frequency) for spasticity management remain debated. The EXOPULSE Mollii Suit uses non-invasive, low-frequency stimulation to induce reciprocal inhibition and modulate spinal interneuron activity, potentially reducing spasticity. This study aims to compare EXOPULSE Mollii + exercise vs. EXOPULSE Mollii alone in improving spasticity and function in MS.

Подробное описание

Spasticity is one of the most common symptoms in multiple sclerosis (MS) patients. Large-scale surveys indicate that over 80% of MS patients experience spasticity during their disease course, with 35-54% reporting moderate to severe spasticity. Spasticity, particularly in the lower extremities, is associated with stiffness, spasms, and pain and negatively affects walking, stair climbing, and sleep. While electrical stimulation is a potential treatment for spasticity, optimal stimulation parameters remain unclear. The most commonly used protocol involves high-frequency stimulation (\~100 Hz), though some studies suggest low-frequency stimulation may also be effective.

The EXOPULSE Mollii suit (EXONEURAL NETWORK AB, Danderyd, Sweden) is a non-invasive, self-administered electrical stimulation system with integrated electrodes. It is designed to reduce spasticity and improve motor function in neurological disorders. The method is based on reciprocal inhibition, where low-frequency, low-intensity stimulation of antagonist muscles activates Ia inhibitory interneurons, reducing spasticity in agonist muscles. Additional mechanisms may include neuroplastic changes in spinal or brain circuits, similar to transcutaneous electrical nerve stimulation (TENS). This study aims to compare the effects of EXOPULSE Mollii + exercise vs. EXOPULSE Mollii alone on spasticity and functionality in MS patients.

Вмешательства

• Устройство EXOPULSE Mollii Suit + Exercise
  First, spasticity will be evaluated using the Modified Ashworth Scale (MAS). Based on this evaluation, the stimulation intensity for each muscle group will be determined and recorded in the system. Once patients put on the EXOPULSE Mollii Suit and the stimulation begins, they will undergo a personalized exercise program including strengthening, balance, and gait training with scheduled rest intervals. All MS patients will undergo treatment three days per week (with at least one day between sessi
• Устройство EXOPULSE Mollii Suit
  First, spasticity will be evaluated using the Modified Ashworth Scale (MAS). Based on this evaluation, the stimulation intensity for each muscle group will be determined and recorded in the system. Patients will wear the suit and receive stimulation while resting for 60 minutes. All MS patients will undergo treatment three days per week (with at least one day between sessions) for one hour per day over four weeks.

Первичные конечные точки

• Modified Ashworth Scale (MAS) [Срок оценки: 4 weeks]
• Berg Balance Scale (BBS) [Срок оценки: 4 weeks]
• OptoGait Gait Analysis System [Срок оценки: 4 weeks]

Вторичные конечные точки (10)

• EDSS (Expanded Disability Status Scale) [Срок оценки: 4 weeks]
• Visual Analog Scale (VAS) for pain and fatigue [Срок оценки: 4 weeks]
• Fatigue Severity Scale [Срок оценки: 4 weeks]
• 9-Hole Peg Test [Срок оценки: 4 weeks]
• 5 Times Sit to Stand Test [Срок оценки: 4 weeks]
• Timed Up and Go (TUG) Test [Срок оценки: 4 weeks]
• 10 meter Walk Test [Срок оценки: 4 weeks]
• 12-Item Multiple Sclerosis Walking Scale [Срок оценки: 4 weeks]
• Functional Independence Measure (FIM) [Срок оценки: 4 weeks]
• Multiple Sclerosis Quality of Life-54 (MSQOL-54) [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• Diagnosed with MS by a neurologist according to McDonald criteria
• Age >18 years
• EDSS score ≤6.5 (able to walk independently without assistive devices)
• Presence of spasticity
• Mini Mental State Examination (MMSE) score ≥24

Критерии исключения

• Received surgical intervention or botulinum toxin injection for spasticity within the last 6 months
• Presence of any neurological condition (other than MS) that may affect independent standing or walking
• Currently participating in another rehabilitation program
• Declined to participate or provide written informed consent

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07126730 · FTREK25/78

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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