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

Sponsor
Sheikh Shakhbout Medical City (Other)
Overall Status
Recruiting
CT.gov ID
NCT05912595
Collaborator
(none)
36
Enrollment
1
Location
2
Arms
13.5
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: EXOPULSE Mollii Suit Stimulation
 N/A

Detailed Description

The study is 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 separated by 2 weeks. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effects of EXOPULSE Mollii Suit on Spasticity and Muscular Oxygenation in Patients With Multiple Sclerosis.
Actual Study Start Date :
May 18, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: EXOPULSE Mollii Suit Stimulation Active.

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
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.
Sham Comparator: EXOPULSE Mollii Suit Stimulation Sham.

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
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.

Outcome Measures

Primary Outcome Measures

  1. Muscular Oxygenation using Near-infrared spectroscopy (NIRS) Measurements [To be assessed at baseline.]

    Muscular Oxygenation will be assessed using the Near-infrared spectroscopy (NIRS) technology using a PortaMon device it will be employed to assess tissue oxygenation parameters (hemoglobin (tHb), oxyhemoglobin (O2Hb), deoxyhemoglobin (HHb), and tissue oxygenation index (TOI%)) in the territory of the spastic muscles before and after each session.

  2. Muscular Oxygenation using Near-infrared spectroscopy (NIRS) Measurements [To be assessed at week 2.]

    Muscular Oxygenation will be assessed using the Near-infrared spectroscopy (NIRS) technology using a PortaMon device it will be employed to assess tissue oxygenation parameters (hemoglobin (tHb), oxyhemoglobin (O2Hb), deoxyhemoglobin (HHb), and tissue oxygenation index (TOI%)) in the territory of the spastic muscles before and after each session.

  3. Muscular Oxygenation using Near-infrared spectroscopy (NIRS) Measurements [To be assessed at week 4.]

    Muscular Oxygenation will be assessed using the Near-infrared spectroscopy (NIRS) technology using a PortaMon device it will be employed to assess tissue oxygenation parameters (hemoglobin (tHb), oxyhemoglobin (O2Hb), deoxyhemoglobin (HHb), and tissue oxygenation index (TOI%)) in the territory of the spastic muscles before and after each session.

  4. Muscular Oxygenation using Near-infrared spectroscopy (NIRS) Measurements [To be assessed at week 8.]

    Muscular Oxygenation will be assessed using the Near-infrared spectroscopy (NIRS) technology using a PortaMon device it will be employed to assess tissue oxygenation parameters (hemoglobin (tHb), oxyhemoglobin (O2Hb), deoxyhemoglobin (HHb), and tissue oxygenation index (TOI%)) in the territory of the spastic muscles before and after each session.

Secondary Outcome Measures

  1. Numerical Rating Scale for spasticity. [This to be assessed at baseline, then at week 2, week 4 and week 8.]

    Spasticity will be evaluated using a Numerical Rating Scale (NRS) score from 0 to 10, 0 being no spasticity and 10 being the worst possible spasticity.

  2. Multiple Sclerosis International Quality of Life Questionnaire. [Two weeks after the second stimulation and 4 weeks later at the end of phase 2.]

    Quality of life will be measured using the 31-item Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) This questionnaire consists of 31 questions covering 9 domains including: 1- activity of daily living, 2- physical well-being, 3- relationships with friends, 4- symptoms, 5- relationships with family; 6- relationships with health care systems, 7- sentimental and sexual life, 8- coping; and 9- rejection. The questions are answered by ticking or checking the box that describes best of what patients would feel ranging from 0 to 4, 0 being not at all and 4 always or very much. For MusiQoL, the score of each of the nine sub domains is calculated as the average for the set of questions making up the domain. An overall score is then calculated as the average of all the scores for each subdomain. Prior to computing the final overall score, each domain-specific score is linearly transformed to a 0-100 scale with O being the worst quality of life and 100 the best.

  3. Visual Analog Score for pain. [This to be assessed at baseline, then at week 2, week 4 and week 8.]

    Pain will be measured using a visual analog score from 0 to 10, 0 being no pain, to 10 being the worst possible pain.

  4. Visual Analog Score for fatigue. [This to be assessed at baseline, then at week 2, week 4 and week 8.]

    Fatigue will be measured using a visual analog score from 0 to 10, 0 being no fatigue, to 10 being the worst possible fatigue.

  5. Fall risk. [Two weeks after the second stimulation and at the end of phase 2.]

    Fall risk will be assessed using the Falls Efficacy Scale- International scale. It is a 16-item scale, including a range of functional activities, that assesses the perceived risk of falling, using a score that will range from 1 to 4, 1 being not at all concerned to 4 being very concerned.

  6. Walking ability. [Two weeks after the second stimulation and at the end of phase 2.]

    Walking ability will be evaluated by the 12-item Multiple Sclerosis Walking Scale (MSWS-12). Each one of the 12 items will be assessed and assigned numbers from 1 to 5, 1 being not at all to 5 being extremely common, and the results will be added to a total of 60, so the higher the score, the better the mobility.

  7. Overall Clinical Improvement. [This to be assessed at baseline, then at week 2, and week 8.]

    Evaluation of overall Clinical improvement will be done using the 7-point Clinical Global Impression (CGI). Patient will fill a questionnaire that will address their clinical situation as follows: Very much improved. Much improved. Slightly improved. No change. Slightly worse Much worse. Very much worse The score will range from 1-7, 1 being the best clinical outcome and 7 the worst.

  8. Blinding Questionnaire. [This to be assessed at baseline, then at week 2.]

    Evaluation of patient's blinding to the type of stimulation in the crossover trial periods using a dedicated questionnaire. Patients will be asked whether they think they received the sham or active stimulation. No scale will be used for this measure.

  9. Weight [Baseline.]

    The patient weight will be measured and recorded in kilograms.

  10. Height [Baseline.]

    The patient height will be measured and recorded in centimeters.

  11. Muscle tone. [Baseline, and through study completion.]

    Muscle tone will be evaluated by the Modified Ashworth Scale (MAS). Scores will range from 0 to 4, 0 being no increase or normal muscle tone, to 4 being rigidity in flexion or extension of muscles.

  12. Body Mass Index (BMI) [Baseline.]

    The weight and height will be combined to report BMI in kg/m^2. BMI of 35 kg/m^2 or more will be used as an exclusion criterion for the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 SSMC Abu Dhabi United Arab Emirates

Sponsors and Collaborators

  • Sheikh Shakhbout Medical City

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Naji Joseph Riachi, Principal Investigator, Sheikh Shakhbout Medical City
ClinicalTrials.gov Identifier:
NCT05912595
Other Study ID Numbers:
  • ENNOX2
First Posted:
Jun 22, 2023
Last Update Posted:
Jun 22, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Muscle Spasticity
Multiple Sclerosis
Sclerosis

Study Results

No Results Posted as of Jun 22, 2023