Multiple SclerosisENNOXNCT05362006
Exopulse Mollii Suit, Spasticity & Tissue Oxygenation
A study testing Exopulse Mollii Suit in people with Multiple Sclerosis, run by Institut De La Colonne Vertebrale Et Des Neurosciences at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Exopulse Mollii Suit
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2022to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a TENS System (Transcutaneous Electric Nerve Stimulation) on Spasticity and Muscular Oxygenation in Patients With Multiple Sclerosis (ENNOX Study)
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Exopulse Mollii Suit, Exopulse Mollii suit (sham)
- Keywords
- Multiple sclerosis, Oxygenation, Muscles, Spasticity
- Medical subject headings
- Multiple Sclerosis, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exopulse Mollii SuitDevice
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.
Exopulse Mollii suit (sham)Device
In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | 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. Receives: Device: Exopulse Mollii Suit |
| Sham | Sham comparator | In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off. Receives: Device: Exopulse Mollii suit (sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in oxyhemoglobin level at baseline and at week 2.
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.
All NIRS measurements will be done while the muscles of interest are kept at complete rest.
Measured: This be assessed at baseline, then at week 2.
Changes in deoxyhemoglobin level at baseline and at week 2.
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.
All NIRS measurements will be done while the muscles of interest are kept at complete rest.
Measured: This be assessed at baseline, then at week 2.
Changes in tissue oxygenation index at baseline and at week 2.
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.
All NIRS measurements will be done while the muscles of interest are kept at complete rest.
Measured: This be assessed at baseline, then at week 2.
Change in total hemoglobin level at baseline and at week 2.
Total hemoglobin level is the sum of oxyhemoglobin and deoxyhemoglobin. It will be evaluated using Near Infrared Technology (NIRS) by means of a PortaMon device. PortaMon device can assess the level of oxyhemoglobin of the muscle in question. All NIRS measurements will be done while the muscles of interest are kept at complete rest.
Measured: This be assessed at baseline and at week 2.
Secondary outcomes (10)
Modified Ashworth Scale (MAS)
MAS ranges from 0 (normal muscle tone ) to 4 (rigidity)
Measured: This be assessed at baseline, then at week 2, week 4 and week 8.
Numerical Rating Scale of spasticity (NRS)
NRS ranges ranges from 0 (no spasticity) to 10 (worse spasticity that the participant can imagine)
Measured: This be assessed at baseline, then at week 2, week 4 and week 8.
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.
Measured: This be assessed at week 4 and week 8.
Changes in oxyhemoglobin level at 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.
All NIRS measurements will be done while the muscles of interest are kept at complete rest.
Measured: This be assessed at week 4 and week 8.
Changes in deoxyhemoglobin level at 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.
All NIRS measurements will be done while the muscles of interest are kept at complete rest.
Measured: This be assessed at week 4 and week 8.
Changes in tissue oxygenation index at 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.
All NIRS measurements will be done while the muscles of interest are kept at complete rest.
Measured: This be assessed at week 4 and week 8.
Changes in total hemoglobin level at week 4 and week 8.
Total hemoglobin level is the sum of oxyhemoglobin and deoxyhemoglobin. It will be evaluated using Near Infrared Technology (NIRS) by means of a PortaMon device. PortaMon device can assess the level of oxyhemoglobin of the muscle in question. All NIRS measurements will be done while the muscles of interest are kept at complete rest.
Measured: This be assessed at week 4 and week 8.
Visual Analog Scale (VAS) pain
VAS ranges ranges from 0 (no pain) to 10 (the worst pain that the participant can imagine)
Measured: This be assessed at baseline, then at week 2, week 4 and week 8.
Mobility will be assessed using the MSWS-12 (Multiple Sclerosis Walking Scale - 12)
Subjective changes in walking would be evaluated in patients who can walk by the Multiple Sclerosis Walking Scale - 12 (MSWS-12), a 12-item scale that examines the impact of MS on walking capacity, is a validated patient-reported measure for exploring this outcome.
Measured: This be assessed at week 4 and week 8.
Mobility will be assessed using the FES-I (Falls Efficacy Scale-International scale)
Subjective risk of fall will be assessed in patients who can walk using the French version of the Falls Efficacy Scale-International scale (FES-I) ; a 14-item scale that assesses the perceived risk of falling.
Measured: This be assessed at week 4 and week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start1 Mar 2022
- Primary completion18 Apr 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut De La Colonne Vertebrale Et Des Neurosciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362006
- Sponsor's protocol ID
- 2021-A01665-36
- Acronym
- ENNOX
- Status last verified
- May 2024
- First submitted
- 24 Jan 2022
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a TENS System (Transcutaneous Electric Nerve Stimulation) on Spasticity and Muscular Oxygenation in Patients With Multiple Sclerosis (ENNOX Study)
- ClinicalTrials.gov ID
- NCT05362006
- Acronym / sponsor ID
- ENNOX / 2021-A01665-36
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Oxygenation, Muscles, Spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Institut De La Colonne Vertebrale Et Des NeurosciencesUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: Exopulse Mollii SuitActive 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. |
| Sham | Sham comparator | Device: Exopulse Mollii suit (sham)In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exopulse Mollii SuitExopulse 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. | Device | Active |
| Exopulse Mollii suit (sham)In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off. | Device | Sham |
Primary outcome
Changes in oxyhemoglobin level at baseline and at week 2.
Time frame: This be assessed at baseline, then at week 2.
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. All NIRS measurements will be done while the muscles of interest are kept at complete rest.
Changes in deoxyhemoglobin level at baseline and at week 2.
Time frame: This be assessed at baseline, then at week 2.
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. All NIRS measurements will be done while the muscles of interest are kept at complete rest.
Changes in tissue oxygenation index at baseline and at week 2.
Time frame: This be assessed at baseline, then at week 2.
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. All NIRS measurements will be done while the muscles of interest are kept at complete rest.
Change in total hemoglobin level at baseline and at week 2.
Time frame: This be assessed at baseline and at week 2.
Total hemoglobin level is the sum of oxyhemoglobin and deoxyhemoglobin. It will be evaluated using Near Infrared Technology (NIRS) by means of a PortaMon device. PortaMon device can assess the level of oxyhemoglobin of the muscle in question. All NIRS measurements will be done while the muscles of interest are kept at complete rest.
10 secondary outcomes
Modified Ashworth Scale (MAS)
Time frame: This be assessed at baseline, then at week 2, week 4 and week 8.
Numerical Rating Scale of spasticity (NRS)
Time frame: This be assessed at baseline, then at week 2, week 4 and week 8.
Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL)
Time frame: This be assessed at week 4 and week 8.
Changes in oxyhemoglobin level at week 4 and week 8.
Time frame: This be assessed at week 4 and week 8.
Changes in deoxyhemoglobin level at week 4 and week 8.
Time frame: This be assessed at week 4 and week 8.
Changes in tissue oxygenation index at week 4 and week 8.
Time frame: This be assessed at week 4 and week 8.
Changes in total hemoglobin level at week 4 and week 8.
Time frame: This be assessed at week 4 and week 8.
Visual Analog Scale (VAS) pain
Time frame: This be assessed at baseline, then at week 2, week 4 and week 8.
Mobility will be assessed using the MSWS-12 (Multiple Sclerosis Walking Scale - 12)
Time frame: This be assessed at week 4 and week 8.
Mobility will be assessed using the FES-I (Falls Efficacy Scale-International scale)
Time frame: This be assessed at week 4 and week 8.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exopulse Mollii Suit in people with Multiple Sclerosis, run by Institut De La Colonne Vertebrale Et Des Neurosciences at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in oxyhemoglobin level at baseline and at week 2. (time frame: This be assessed at baseline, then at week 2.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.