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

Primary Purpose

Sclerosis, Multiple, MS (Multiple Sclerosis), Spastic

Status
Recruiting
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
EXOPULSE Mollii Suit Stimulation
Sponsored by
Sheikh Shakhbout Medical City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sclerosis, Multiple

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • SSMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

EXOPULSE Mollii Suit Stimulation Active.

EXOPULSE Mollii Suit Stimulation Sham.

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Numerical Rating Scale for spasticity.
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.
Multiple Sclerosis International Quality of Life Questionnaire.
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.
Visual Analog Score for pain.
Pain will be measured using a visual analog score from 0 to 10, 0 being no pain, to 10 being the worst possible pain.
Visual Analog Score for fatigue.
Fatigue will be measured using a visual analog score from 0 to 10, 0 being no fatigue, to 10 being the worst possible fatigue.
Fall risk.
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.
Walking ability.
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.
Overall Clinical Improvement.
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.
Blinding Questionnaire.
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.
Weight
The patient weight will be measured and recorded in kilograms.
Height
The patient height will be measured and recorded in centimeters.
Muscle tone.
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.
Body Mass Index (BMI)
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.

Full Information

First Posted
June 12, 2023
Last Updated
July 29, 2023
Sponsor
Sheikh Shakhbout Medical City
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1. Study Identification

Unique Protocol Identification Number
NCT05912595
Brief Title
EXOPULSE Mollii Suit, Spasticity, Muscular Oxygenation & Multiple Sclerosis (ENNOX 2)
Official Title
The Effects of EXOPULSE Mollii Suit on Spasticity and Muscular Oxygenation in Patients With Multiple Sclerosis.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheikh Shakhbout Medical City

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sclerosis, Multiple, MS (Multiple Sclerosis), Spastic, Spasticity, Muscle, Oxygen Consumption

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EXOPULSE Mollii Suit Stimulation Active.
Arm Type
Active Comparator
Arm Description
This will be the EXOPULSE Mollii Suit Active Stimulation. Stimulation will go on for 60 minutes while control unit is on for 60 minutes.
Arm Title
EXOPULSE Mollii Suit Stimulation Sham.
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
EXOPULSE Mollii Suit Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscular Oxygenation using Near-infrared spectroscopy (NIRS) Measurements
Description
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.
Time Frame
To be assessed at baseline, week 2, week 4 and week 8
Title
Muscular Oxygenation using Near-infrared spectroscopy (NIRS) Measurements
Description
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.
Time Frame
To be assessed at baseline, week 2, week 4 and week 8
Title
Muscular Oxygenation using Near-infrared spectroscopy (NIRS) Measurements
Description
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.
Time Frame
To be assessed at baseline, week 2, week 4 and week 8
Title
Muscular Oxygenation using Near-infrared spectroscopy (NIRS) Measurements
Description
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.
Time Frame
To be assessed at baseline, week 2, week 4 and week 8
Secondary Outcome Measure Information:
Title
Numerical Rating Scale for spasticity.
Description
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.
Time Frame
This to be assessed at baseline, then at week 2, week 4 and week 8.
Title
Multiple Sclerosis International Quality of Life Questionnaire.
Description
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.
Time Frame
Two weeks after the second stimulation and 4 weeks later at the end of phase 2.
Title
Visual Analog Score for pain.
Description
Pain will be measured using a visual analog score from 0 to 10, 0 being no pain, to 10 being the worst possible pain.
Time Frame
This to be assessed at baseline, then at week 2, week 4 and week 8.
Title
Visual Analog Score for fatigue.
Description
Fatigue will be measured using a visual analog score from 0 to 10, 0 being no fatigue, to 10 being the worst possible fatigue.
Time Frame
This to be assessed at baseline, then at week 2, week 4 and week 8.
Title
Fall risk.
Description
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.
Time Frame
Two weeks after the second stimulation and at the end of phase 2.
Title
Walking ability.
Description
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.
Time Frame
Two weeks after the second stimulation and at the end of phase 2.
Title
Overall Clinical Improvement.
Description
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.
Time Frame
This to be assessed at baseline, then at week 2, and week 8.
Title
Blinding Questionnaire.
Description
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.
Time Frame
This to be assessed at baseline, then at week 2.
Title
Weight
Description
The patient weight will be measured and recorded in kilograms.
Time Frame
Baseline.
Title
Height
Description
The patient height will be measured and recorded in centimeters.
Time Frame
Baseline.
Title
Muscle tone.
Description
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.
Time Frame
Baseline, and through study completion.
Title
Body Mass Index (BMI)
Description
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.
Time Frame
Baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naji J Riachi, MD
Phone
+971 2 314 4444
Ext
2979
Email
nriachi@ssmc.ae
First Name & Middle Initial & Last Name or Official Title & Degree
Hasan M Jaber, Bsc
Phone
+971 2 314 4444
Ext
3869
Email
hasjaber@ssmc.ae
Facility Information:
Facility Name
SSMC
City
Abu Dhabi
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naji J Riachi, MD
Phone
+971 2 314 4444
Ext
2979
Email
nriachi@ssmc.ae
First Name & Middle Initial & Last Name & Degree
Hasan M Jaber, Bsc
Phone
+971 2 314 4444
Ext
3869
Email
hasjaber@ssmc.ae
First Name & Middle Initial & Last Name & Degree
Naji J Riachi, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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