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

NCT ID: NCT07126730

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-02-01

Brief Summary

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EXOPULSE Mollii + Exercise

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

Group Type: EXPERIMENTAL

EXOPULSE Mollii Suit + Exercise

Intervention Type: DEVICE

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 sessions) for one hour per day over four weeks.

EXOPULSE Mollii

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

Group Type: ACTIVE_COMPARATOR

EXOPULSE Mollii Suit

Intervention Type: DEVICE

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.

Interventions

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 sessions) for one hour per day over four weeks.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Muhammed KILINÇ

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammed KILINÇ, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Central Contacts

Özge ONURSAL KILINÇ, PhD

Role: CONTACT

ozgeonursal@hacettepe.edu.tr

+903123051576 ext. 183

Other Identifiers

FTREK25/78

Identifier Type: -

Identifier Source: org_study_id