Effects of EXOPULSE Mollii Suit on Spasticity and Functionality in Multiple Sclerosis Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EXOPULSE Mollii Suit + Exercise, EXOPULSE Mollii Suit.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Investigating the Effects of the EXOPULSE Mollii Suit on Spasticity and Functionality in Patients With Multiple Sclerosis
Overview
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.
Detailed description
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.
Interventions
- Device 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 - Device 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.
Primary outcome measures
- Modified Ashworth Scale (MAS) [Time frame: 4 weeks]
- Berg Balance Scale (BBS) [Time frame: 4 weeks]
- OptoGait Gait Analysis System [Time frame: 4 weeks]
Secondary outcome measures (10)
- EDSS (Expanded Disability Status Scale) [Time frame: 4 weeks]
- Visual Analog Scale (VAS) for pain and fatigue [Time frame: 4 weeks]
- Fatigue Severity Scale [Time frame: 4 weeks]
- 9-Hole Peg Test [Time frame: 4 weeks]
- 5 Times Sit to Stand Test [Time frame: 4 weeks]
- Timed Up and Go (TUG) Test [Time frame: 4 weeks]
- 10 meter Walk Test [Time frame: 4 weeks]
- 12-Item Multiple Sclerosis Walking Scale [Time frame: 4 weeks]
- Functional Independence Measure (FIM) [Time frame: 4 weeks]
- Multiple Sclerosis Quality of Life-54 (MSQOL-54) [Time frame: 4 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07126730 · FTREK25/78