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

Hacettepe University

Status: Not yet enrolling

Conditions: Multiple Sclerosis

Treatments: Device: EXOPULSE Mollii Suit + Exercise; Device: EXOPULSE Mollii Suit

Study type: Interventional

Funder types: Other

Identifiers

NCT07126730

FTREK25/78

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

EXOPULSE Mollii + Exercise

Experimental group

Description:

During the 60-minute EXOPULSE Mollii stimulation session, patients will also perform a guided exercise program.

Treatment:

Device: EXOPULSE Mollii Suit + Exercise

EXOPULSE Mollii

Active Comparator group

Description:

For 60 minutes, patients will only receive stimulation while wearing the EXOPULSE Mollii suit.

Treatment:

Device: EXOPULSE Mollii Suit