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Exopulse Mollii Suit, Spasticity & Tissue Oxygenation (ENNOX)

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Exopulse Mollii Suit
Exopulse Mollii suit (sham)
Sponsored by
Institut De La Colonne Vertebrale Et Des Neurosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Oxygenation, Muscles, Spasticity

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.
  • Being French speaker, able to understand verbal instructions, and affiliated to the national health insurance (sécurité sociale).
  • Having spasticity with a score of at least 1+ on the MAS.

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 (" mesure de protection judiciare : tutelle, curatelle, sauvegarde de justice ")
  • Prisoners.

Sites / Locations

  • Hopital Henri MondorRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active

Sham

Arm Description

Active sessions will last 1 hour each. The following parameters will be used for electric stimulation: low frequency (20 Hz), low current intensity (2 mA), with a small pulse width of 25-170 microseconds.

In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.

Outcomes

Primary Outcome Measures

Changes from baseline oxyhemoglobin level at week 2, week 4 and week 8.
Oxygemoglobin level will be evaluated using Near Infrared Technology (NIRS) by means of a PortaMon device. This is a wireless device - PortaMon (Artinis Medical Systems, The Netherlands) that consists of three light emitting diodes, each sending two wavelengths and four channels to measure tissue oxygenation. PortaMon device can assess the level of oxyhemoglobin of the muscle in question. We will use two devices per patient. All NIRS measurements will be done while the muscles of interest are kept at complete rest.
Changes from baseline deoxyhemoglobin level at week 2, week 4 and week 8.
Deoxyhemoglobin level will be evaluated using the same Near Infrared Technology (NIRS) by means of a PortaMon device as previously described. The device can assess the level of deoxyhemoglobin of the muscle in question. We will use two devices per patient. All NIRS measurements will be done while the muscles of interest are kept at complete rest.
Changes from baseline tissue oxygenation index at week 2, week 4 and week 8.
Tissue oxygenation index will be evaluated using NIRS technology. A wireless device PortaMon (Artinis Medical Systems, The Netherlands)- is designed for this purpose, it consists of three light emitting diodes, each sending two wavelengths and four channels to measure tissue oxygenation index. We will use two devices per patient. All NIRS measurements will be done while the muscles of interest are kept at complete rest.

Secondary Outcome Measures

Modified Ashworth Scale (MAS)
MAS ranges from 0 (normal muscle tone ) to 4 (rigidity)
Numerical Rating Scale of spasticity (NRS)
NRS ranges ranges from 0 (no spasticity) to 10 (worse spasticity that the participant can imagine)
Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL)
Quality of life will be measured using the 31-item Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL). The MusiQoL questionnaire comprises 31 questions in 9 dimensions (subscales): activities of daily living (ADL, 8 items), psychological well-being (PWB, 4), symptoms (SPT, 4), relationships with friends (RFr, 3), relationships with family (RFa, 3), sentimental and sexual life (SSL, 2), coping (COP, 2), rejection (REJ, 2), and relationships with healthcare system (RHCS, 3). The index score is computed as the mean of these subscale scores. All 9 dimensions and the index score are linearly transformed and standardized on a 0 to 100 scale, where 0 indicates the worst possible level of QoL and 100 indicates the best level.

Full Information

First Posted
January 24, 2022
Last Updated
May 6, 2022
Sponsor
Institut De La Colonne Vertebrale Et Des Neurosciences
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1. Study Identification

Unique Protocol Identification Number
NCT05362006
Brief Title
Exopulse Mollii Suit, Spasticity & Tissue Oxygenation
Acronym
ENNOX
Official Title
The Effects of a TENS System (Transcutaneous Electric Nerve Stimulation) on Spasticity and Muscular Oxygenation in Patients With Multiple Sclerosis (ENNOX Study)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut De La Colonne Vertebrale Et Des Neurosciences

4. Oversight

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

5. Study Description

Brief Summary
Spasticity is a frequent and debilitating symptom in patients with multiple sclerosis (MS). Sustained contractile activity, such as that observed in spastic muscles, could reduce the capillary density and induce important changes in the muscular microcirculation, leading to oxidative changes within the muscular tissue. Such changes reflect altered aerobic metabolism and impaired mitochondrial function. The available therapeutic strategies for treating spasticity and related symptoms are usually faced with limited efficacy and numerous side effects. For these reasons, non-invasive stimulation techniques, namely transcutaneous stimulation by means of Exopulse Mollii suit, might be of help in this context.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis, Oxygenation, Muscles, Spasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Active Comparator
Arm Description
Active sessions will last 1 hour each. The following parameters will be used for electric stimulation: low frequency (20 Hz), low current intensity (2 mA), with a small pulse width of 25-170 microseconds.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.
Intervention Type
Device
Intervention Name(s)
Exopulse Mollii Suit
Intervention Description
Exopulse Mollii suit is a new assistive device that has been developed by Exoneural Network (initially Inerventions AB), a Swedish med-tech company. Exopulse Mollii suit is a full-body garment with integrated 58 electrodes that can transcutaneously stimulate 40 groups of muscles. This stimulation is not intended to obtain a motor effect (contraction of the muscles in question), but rather to decrease the spasticity in spastic muscles by activating the antagonistic muscles via the physiological mechanism of reciprocal inhibition. The device is CE labelled and is intended to use for reducing spasticity and improving blood circulation. The outfit is very easy to put on, it can be used for one hour every day and the analgesic effects last 24 hours or more.
Intervention Type
Device
Intervention Name(s)
Exopulse Mollii suit (sham)
Intervention Description
In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.
Primary Outcome Measure Information:
Title
Changes from baseline oxyhemoglobin level at week 2, week 4 and week 8.
Description
Oxygemoglobin level will be evaluated using Near Infrared Technology (NIRS) by means of a PortaMon device. This is a wireless device - PortaMon (Artinis Medical Systems, The Netherlands) that consists of three light emitting diodes, each sending two wavelengths and four channels to measure tissue oxygenation. PortaMon device can assess the level of oxyhemoglobin of the muscle in question. We will use two devices per patient. All NIRS measurements will be done while the muscles of interest are kept at complete rest.
Time Frame
This be assessed at baseline, then at week 2, week 4 and week 8.
Title
Changes from baseline deoxyhemoglobin level at week 2, week 4 and week 8.
Description
Deoxyhemoglobin level will be evaluated using the same Near Infrared Technology (NIRS) by means of a PortaMon device as previously described. The device can assess the level of deoxyhemoglobin of the muscle in question. We will use two devices per patient. All NIRS measurements will be done while the muscles of interest are kept at complete rest.
Time Frame
This be assessed at baseline, then at week 2, week 4 and week 8.
Title
Changes from baseline tissue oxygenation index at week 2, week 4 and week 8.
Description
Tissue oxygenation index will be evaluated using NIRS technology. A wireless device PortaMon (Artinis Medical Systems, The Netherlands)- is designed for this purpose, it consists of three light emitting diodes, each sending two wavelengths and four channels to measure tissue oxygenation index. We will use two devices per patient. All NIRS measurements will be done while the muscles of interest are kept at complete rest.
Time Frame
This be assessed at baseline, then at week 2, week 4 and week 8.
Secondary Outcome Measure Information:
Title
Modified Ashworth Scale (MAS)
Description
MAS ranges from 0 (normal muscle tone ) to 4 (rigidity)
Time Frame
This be assessed at baseline, then at week 2, week 4 and week 8.
Title
Numerical Rating Scale of spasticity (NRS)
Description
NRS ranges ranges from 0 (no spasticity) to 10 (worse spasticity that the participant can imagine)
Time Frame
This be assessed at baseline, then at week 2, week 4 and week 8.
Title
Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL)
Description
Quality of life will be measured using the 31-item Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL). The MusiQoL questionnaire comprises 31 questions in 9 dimensions (subscales): activities of daily living (ADL, 8 items), psychological well-being (PWB, 4), symptoms (SPT, 4), relationships with friends (RFr, 3), relationships with family (RFa, 3), sentimental and sexual life (SSL, 2), coping (COP, 2), rejection (REJ, 2), and relationships with healthcare system (RHCS, 3). The index score is computed as the mean of these subscale scores. All 9 dimensions and the index score are linearly transformed and standardized on a 0 to 100 scale, where 0 indicates the worst possible level of QoL and 100 indicates the best level.
Time Frame
This be assessed at baseline, then at week 2, week 4 and week 8.

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. Being French speaker, able to understand verbal instructions, and affiliated to the national health insurance (sécurité sociale). Having spasticity with a score of at least 1+ on the MAS. 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 (" mesure de protection judiciare : tutelle, curatelle, sauvegarde de justice ") Prisoners.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SAMAR S. AYACHE, MD, PhD
Phone
0149814662
Email
samarayache@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Moussa A Chalah, MD, PhD
Phone
0149814662
Email
moussachalah@gmail.com
Facility Information:
Facility Name
Hopital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samar Ayache, MD, PhD
Phone
+33149814662
Email
samarayache@gmail.com
First Name & Middle Initial & Last Name & Degree
Samar S Ayache, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Exopulse Mollii Suit, Spasticity & Tissue Oxygenation

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