EXOPULSE Mollii Suit, Spasticity, Muscular Oxygenation & Multiple Sclerosis (ENNOX 2)

NCT05912595 | Unknown DMC

• 1 other identifier: ENNOX2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to demonstrate the improvement of muscular oxygenation in patients with Multiple Sclerosis and spasticity using Exopulse Molli suit stimulation. The main questions it aims to answer are:

• to evaluate the short-term impact of EXOPULSE Molli suit on muscular oxygenation in adult MS patients suffering from spasticity.
• to assess the effects of Exopulse Mollii suit on spasticity, pain, fatigue, quality of life (QoL), walking and risk of fall. Study subjects will participate in:
• One baseline visit for inclusion in the study during which the patient will undergo the first session (active or sham) along with an evaluation before and after the session
• One visit after two weeks during which the patient will undergo the second session (active or sham) along with an evaluation before and after the session
• One visit two weeks after the second stimulation; where the patients will undergo a fifth evaluation and receive the EXOPULSE Molli Suit for the four-week open label phase to use the suit at home for an active stimulation session every other day for four weeks.
• One visit at the end of the open label phase to perform the sixth and last evaluation and return the EXOPULSE Molli suit. Researchers will compare both Active and Sham groups to demonstrate the improvement of muscular oxygenation in patients with MS and spasticity using Exopulse Molli.

Conditions

Sclerosis, Multiple; MS (Multiple Sclerosis); Spastic; Spasticity, Muscle; Oxygen Consumption

Outcome Measures

Primary Outcomes (4)

• Muscular Oxygenation using Near-infrared spectroscopy (NIRS) Measurements

  Muscular Oxygenation will be assessed using the Near-infrared spectroscopy (NIRS) technology using a PortaMon device it will be employed to assess tissue oxygenation parameter (hemoglobin (tHb) in the territory of the spastic muscles before and after each session.

  To be assessed at baseline, week 2, week 4 and week 8

• Muscular Oxygenation using Near-infrared spectroscopy (NIRS) Measurements

  Muscular Oxygenation will be assessed using the Near-infrared spectroscopy (NIRS) technology using a PortaMon device it will be employed to assess tissue oxygenation parameter oxyhemoglobin (O2Hb) in the territory of the spastic muscles before and after each session.

  To be assessed at baseline, week 2, week 4 and week 8

• Muscular Oxygenation using Near-infrared spectroscopy (NIRS) Measurements

  Muscular Oxygenation will be assessed using the Near-infrared spectroscopy (NIRS) technology using a PortaMon device it will be employed to assess tissue oxygenation parameter deoxyhemoglobin (HHb) in the territory of the spastic muscles before and after each session.

  To be assessed at baseline, week 2, week 4 and week 8

• Muscular Oxygenation using Near-infrared spectroscopy (NIRS) Measurements

  Muscular Oxygenation will be assessed using the Near-infrared spectroscopy (NIRS) technology using a PortaMon device it will be employed to assess tissue oxygenation parameter tissue oxygenation index (TOI%)) in the territory of the spastic muscles before and after each session.

  To be assessed at baseline, week 2, week 4 and week 8

Secondary Outcomes (12)

• Numerical Rating Scale for spasticity.

  This to be assessed at baseline, then at week 2, week 4 and week 8.

• Multiple Sclerosis International Quality of Life Questionnaire.

  Two weeks after the second stimulation and 4 weeks later at the end of phase 2.

• Visual Analog Score for pain.

  This to be assessed at baseline, then at week 2, week 4 and week 8.

• Visual Analog Score for fatigue.

  This to be assessed at baseline, then at week 2, week 4 and week 8.

• Fall risk.

  Two weeks after the second stimulation and at the end of phase 2.

Study Arms (2)

EXOPULSE Mollii Suit Stimulation Active.

ACTIVE COMPARATOR

This will be the EXOPULSE Mollii Suit Active Stimulation. Stimulation will go on for 60 minutes while control unit is on for 60 minutes.

Device: EXOPULSE Mollii Suit Stimulation

EXOPULSE Mollii Suit Stimulation Sham.

SHAM COMPARATOR

This will be the EXOPULSE Mollii Suit Sham Stimulation. Stimulation will go on for 1 minute then it turns off while the control unit will remain on for total of 60 minutes.

Device: EXOPULSE Mollii Suit Stimulation

Interventions

EXOPULSE Mollii Suit Stimulation DEVICE

We designed a randomized crossover, sham-controlled, double-blind trial to demonstrate the improvement of tissue oxygenation and frequent MS symptoms following a single session of "active" versus "sham" Exopulse Mollii suit. A 2-week washout period should be enough to prevent a potential carry over effect. After this phase (phase 1), a second open label phase (phase 2) will be proposed for patients to understand the effects of Exopulse Mollii suit employed for one month (3 sessions per week) on tissue oxygenation and MS related symptoms.

EXOPULSE Mollii Suit Stimulation Active.; EXOPULSE Mollii Suit Stimulation Sham.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Definite MS diagnosis according to the 2017 McDonald criteria since at least one month.
• Age between 18 and 75 years.
• Ability to walk freely or with the need of support (expanded disability status scale score (EDSS) \< 7.5).
• Being free of relapses in the last three months.
• Having spasticity with a score of at least 1+ on the MAS.
• Female patients of child-bearing potential must agree to use adequate birth control measures
• Voluntarily given, fully informed written and signed consent obtained before any study related procedures are conducted

You may not qualify if:

• Being included in another research protocol during the study period.
• Inability to undergo medical monitor for the study purposes due to geographical or social reasons.
• Having a cardiac stimulator, a ventriculoperitoneal shunt, an intrathecal baclofen pump or other contraindications to using Exopulse Mollii suit.
• Being pregnant.
• Having a change in their pharmacological therapy in the last three months.
• Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain).
• Having a body mass index above 35 Kg/m2.
• In case of the introduction of a medical device other than Exopulse Mollii suit during the study period.
• Patients under juridical protection.
• Prisoners.

Sponsors & Collaborators

• Sheikh Shakhbout Medical City: lead

Study Sites (1)

SSMC

Abu Dhabi, United Arab Emirates

RECRUITING

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MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Naji J Riachi, MD

CONTACT

+971 2 314 4444; nriachi@ssmc.ae

Hasan M Jaber, Bsc

CONTACT

+971 2 314 4444; hasjaber@ssmc.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: May 18, 2023
• Primary Completion: March 31, 2024
• Study Completion: July 1, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)