Sclerosis, MultipleNCT05912595
EXOPULSE Mollii Suit, Spasticity, Muscular Oxygenation & Multiple Sclerosis (ENNOX 2)
A study testing EXOPULSE Mollii Suit Stimulation in people with Sclerosis, Multiple and MS (Multiple Sclerosis), run by Sheikh Shakhbout Medical City at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sclerosis, Multiple, MS (Multiple Sclerosis), Spastic
- What is being tested?
- EXOPULSE Mollii Suit Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 18 May 2023to 1 Jul 2024
- 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.
- 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
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).
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
SSMC
Abu Dhabi
Naji J Riachi, MD, +971 2 314 4444 ext. 2979, nriachi@ssmc.ae
Hasan M Jaber, Bsc, +971 2 314 4444 ext. 3869, hasjaber@ssmc.ae
About this study
Official title: The Effects of EXOPULSE Mollii Suit on Spasticity and Muscular Oxygenation in Patients With Multiple Sclerosis.
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.
Read more
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.
Read the 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.
- Conditions
- Sclerosis, Multiple, MS (Multiple Sclerosis), Spastic, Spasticity, Muscle, Oxygen Consumption
- Being tested
- EXOPULSE Mollii Suit Stimulation
- 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 Suit StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: EXOPULSE Mollii Suit Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: To be assessed at baseline, week 2, week 4 and week 8
Secondary outcomes (12)
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.
Measured: This to be assessed at baseline, then at week 2, week 4 and week 8.
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.
Measured: Two weeks after the second stimulation and 4 weeks later at the end of phase 2.
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.
Measured: This to be assessed at baseline, then at week 2, week 4 and week 8.
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.
Measured: This to be assessed at baseline, then at week 2, week 4 and week 8.
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.
Measured: Two weeks after the second stimulation and at the end of phase 2.
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.
Measured: Two weeks after the second stimulation and at the end of phase 2.
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.
Measured: This to be assessed at baseline, then at week 2, and week 8.
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.
Measured: This to be assessed at baseline, then at week 2.
Weight
The patient weight will be measured and recorded in kilograms.
Measured: Baseline.
Height
The patient height will be measured and recorded in centimeters.
Measured: Baseline.
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.
Measured: Baseline, and through study completion.
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.
Measured: Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start18 May 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (69)Papers the sponsor has linked to this study.
- Other trials for Sclerosis, MultipleStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheikh Shakhbout Medical City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naji Joseph Riachi, Sheikh Shakhbout Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912595
- Sponsor's protocol ID
- ENNOX2
- Status last verified
- Jan 2024
- First submitted
- 12 Jun 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andringa A, van de Port I, van Wegen E, Ket J, Meskers C, Kwakkel G. Effectiveness of Botulinum Toxin Treatment for Upper Limb Spasticity Poststroke Over Different ICF Domains: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2019 Sep;100(9):1703-1725. doi: 10.1016/j.apmr.2019.01.016. Epub 2019 Feb 21.
PubMed 30796921Andersen IT, Harrison A, Broholm R, Harder A, Nielsen JB, Bulow J, Pingel J. Microvascularization is not a limiting factor for exercise in adults with cerebral palsy. J Appl Physiol (1985). 2018 Aug 1;125(2):536-544. doi: 10.1152/japplphysiol.00827.2017. Epub 2018 May 3.
PubMed 29722625Aree-uea B, Auvichayapat N, Janyacharoen T, Siritaratiwat W, Amatachaya A, Prasertnoo J, Tunkamnerdthai O, Thinkhamrop B, Jensen MP, Auvichayapat P. Reduction of spasticity in cerebral palsy by anodal transcranial direct current stimulation. J Med Assoc Thai. 2014 Sep;97(9):954-62.
PubMed 25536713Arroyo R, Massana M, Vila C. Correlation between spasticity and quality of life in patients with multiple sclerosis: the CANDLE study. Int J Neurosci. 2013 Dec;123(12):850-8. doi: 10.3109/00207454.2013.812084. Epub 2013 Jul 15.
PubMed 23819835Bakaniene I, Urbonaviciene G, Janaviciute K, Prasauskiene A. Effects of the Inerventions method on gross motor function in children with spastic cerebral palsy. Neurol Neurochir Pol. 2018 Sep-Oct;52(5):581-586. doi: 10.1016/j.pjnns.2018.07.003. Epub 2018 Jul 20.
PubMed 30061001Bar-On L, Molenaers G, Aertbelien E, Van Campenhout A, Feys H, Nuttin B, Desloovere K. Spasticity and its contribution to hypertonia in cerebral palsy. Biomed Res Int. 2015;2015:317047. doi: 10.1155/2015/317047. Epub 2015 Jan 11.
PubMed 25649546Baude M, Nielsen JB, Gracies JM. The neurophysiology of deforming spastic paresis: A revised taxonomy. Ann Phys Rehabil Med. 2019 Nov;62(6):426-430. doi: 10.1016/j.rehab.2018.10.004. Epub 2018 Nov 28.
PubMed 30500361Baumstarck-Barrau K, Pelletier J, Simeoni MC, Auquier P; MusiQol Study Group. [French validation of the Multiple Sclerosis International Quality of Life Questionnaire]. Rev Neurol (Paris). 2011 Jun-Jul;167(6-7):511-21. doi: 10.1016/j.neurol.2010.10.008. Epub 2011 Mar 21. French.
PubMed 21420136Beard S, Hunn A, Wight J. Treatments for spasticity and pain in multiple sclerosis: a systematic review. Health Technol Assess. 2003;7(40):iii, ix-x, 1-111. doi: 10.3310/hta7400.
PubMed 14636486Bethoux F. Spasticity Management After Stroke. Phys Med Rehabil Clin N Am. 2015 Nov;26(4):625-39. doi: 10.1016/j.pmr.2015.07.003. Epub 2015 Sep 26.
PubMed 26522902Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
PubMed 3809245Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
PubMed 20526405Campbell WI, Lewis S. Visual analogue measurement of pain. Ulster Med J. 1990 Oct;59(2):149-54.
PubMed 2278111Centonze D, Koch G, Versace V, Mori F, Rossi S, Brusa L, Grossi K, Torelli F, Prosperetti C, Cervellino A, Marfia GA, Stanzione P, Marciani MG, Boffa L, Bernardi G. Repetitive transcranial magnetic stimulation of the motor cortex ameliorates spasticity in multiple sclerosis. Neurology. 2007 Mar 27;68(13):1045-50. doi: 10.1212/01.wnl.0000257818.16952.62.
PubMed 17389310Cogiamanian F, Ardolino G, Vergari M, Ferrucci R, Ciocca M, Scelzo E, Barbieri S, Priori A. Transcutaneous spinal direct current stimulation. Front Psychiatry. 2012 Jul 4;3:63. doi: 10.3389/fpsyt.2012.00063. eCollection 2012.
PubMed 22783208
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of EXOPULSE Mollii Suit on Spasticity and Muscular Oxygenation in Patients With Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT05912595
- Acronym / sponsor ID
- ENNOX2
- Conditions
- Sclerosis, Multiple, MS (Multiple Sclerosis), Spastic, Spasticity, Muscle, Oxygen Consumption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Sheikh Shakhbout Medical CityUniversity, hospital or other
- Study start
- 18 May 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 22 Jun 2023 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXOPULSE Mollii Suit Stimulation Active. | Active comparator | Device: EXOPULSE Mollii Suit StimulationThis will be the EXOPULSE Mollii Suit Active Stimulation. Stimulation will go on for 60 minutes while control unit is on for 60 minutes. |
| EXOPULSE Mollii Suit Stimulation Sham. | Sham comparator | Device: EXOPULSE Mollii Suit StimulationThis 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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.
- Having spasticity with a score of at least 1+ on the MAS.
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 Suit StimulationWe 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. | Device | EXOPULSE Mollii Suit Stimulation Active., EXOPULSE Mollii Suit Stimulation Sham. |
Primary outcome
Muscular Oxygenation using Near-infrared spectroscopy (NIRS) Measurements
Time frame: To be assessed at baseline, week 2, week 4 and 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 parameter (hemoglobin (tHb) in the territory of the spastic muscles before and after each session.
Muscular Oxygenation using Near-infrared spectroscopy (NIRS) Measurements
Time frame: To be assessed at baseline, week 2, week 4 and 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 parameter oxyhemoglobin (O2Hb) in the territory of the spastic muscles before and after each session.
Muscular Oxygenation using Near-infrared spectroscopy (NIRS) Measurements
Time frame: To be assessed at baseline, week 2, week 4 and 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 parameter deoxyhemoglobin (HHb) in the territory of the spastic muscles before and after each session.
Muscular Oxygenation using Near-infrared spectroscopy (NIRS) Measurements
Time frame: To be assessed at baseline, week 2, week 4 and 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 parameter tissue oxygenation index (TOI%)) in the territory of the spastic muscles before and after each session.
12 secondary outcomes
Numerical Rating Scale for spasticity.
Time frame: This to be assessed at baseline, then at week 2, week 4 and week 8.
Multiple Sclerosis International Quality of Life Questionnaire.
Time frame: Two weeks after the second stimulation and 4 weeks later at the end of phase 2.
Visual Analog Score for pain.
Time frame: This to be assessed at baseline, then at week 2, week 4 and week 8.
Visual Analog Score for fatigue.
Time frame: This to be assessed at baseline, then at week 2, week 4 and week 8.
Fall risk.
Time frame: Two weeks after the second stimulation and at the end of phase 2.
Walking ability.
Time frame: Two weeks after the second stimulation and at the end of phase 2.
Overall Clinical Improvement.
Time frame: This to be assessed at baseline, then at week 2, and week 8.
Blinding Questionnaire.
Time frame: This to be assessed at baseline, then at week 2.
Weight
Time frame: Baseline.
Height
Time frame: Baseline.
Muscle tone.
Time frame: Baseline, and through study completion.
Body Mass Index (BMI)
Time frame: Baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Background: PubMed 30796921Andringa A, van de Port I, van Wegen E, Ket J, Meskers C, Kwakkel G. Effectiveness of Botulinum Toxin Treatment for Upper Limb Spasticity Poststroke Over Different ICF Domains: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2019 Sep;100(9):1703-1725. doi: 10.1016/j.apmr.2019.01.016. Epub 2019 Feb 21.
- Background: PubMed 29722625Andersen IT, Harrison A, Broholm R, Harder A, Nielsen JB, Bulow J, Pingel J. Microvascularization is not a limiting factor for exercise in adults with cerebral palsy. J Appl Physiol (1985). 2018 Aug 1;125(2):536-544. doi: 10.1152/japplphysiol.00827.2017. Epub 2018 May 3.
- Background: PubMed 25536713Aree-uea B, Auvichayapat N, Janyacharoen T, Siritaratiwat W, Amatachaya A, Prasertnoo J, Tunkamnerdthai O, Thinkhamrop B, Jensen MP, Auvichayapat P. Reduction of spasticity in cerebral palsy by anodal transcranial direct current stimulation. J Med Assoc Thai. 2014 Sep;97(9):954-62.
- Background: PubMed 23819835Arroyo R, Massana M, Vila C. Correlation between spasticity and quality of life in patients with multiple sclerosis: the CANDLE study. Int J Neurosci. 2013 Dec;123(12):850-8. doi: 10.3109/00207454.2013.812084. Epub 2013 Jul 15.
- Background: PubMed 30061001Bakaniene I, Urbonaviciene G, Janaviciute K, Prasauskiene A. Effects of the Inerventions method on gross motor function in children with spastic cerebral palsy. Neurol Neurochir Pol. 2018 Sep-Oct;52(5):581-586. doi: 10.1016/j.pjnns.2018.07.003. Epub 2018 Jul 20.
- Background: PubMed 25649546Bar-On L, Molenaers G, Aertbelien E, Van Campenhout A, Feys H, Nuttin B, Desloovere K. Spasticity and its contribution to hypertonia in cerebral palsy. Biomed Res Int. 2015;2015:317047. doi: 10.1155/2015/317047. Epub 2015 Jan 11.
- Background: PubMed 30500361Baude M, Nielsen JB, Gracies JM. The neurophysiology of deforming spastic paresis: A revised taxonomy. Ann Phys Rehabil Med. 2019 Nov;62(6):426-430. doi: 10.1016/j.rehab.2018.10.004. Epub 2018 Nov 28.
- Background: PubMed 21420136Baumstarck-Barrau K, Pelletier J, Simeoni MC, Auquier P; MusiQol Study Group. [French validation of the Multiple Sclerosis International Quality of Life Questionnaire]. Rev Neurol (Paris). 2011 Jun-Jul;167(6-7):511-21. doi: 10.1016/j.neurol.2010.10.008. Epub 2011 Mar 21. French.
- Background: PubMed 14636486Beard S, Hunn A, Wight J. Treatments for spasticity and pain in multiple sclerosis: a systematic review. Health Technol Assess. 2003;7(40):iii, ix-x, 1-111. doi: 10.3310/hta7400.
- Background: PubMed 26522902Bethoux F. Spasticity Management After Stroke. Phys Med Rehabil Clin N Am. 2015 Nov;26(4):625-39. doi: 10.1016/j.pmr.2015.07.003. Epub 2015 Sep 26.
- Background: PubMed 3809245Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
- Background: PubMed 20526405Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
- Individual participant dataSharing planned: No
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Multiple Sclerosis
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.
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 Stimulation in people with Sclerosis, Multiple and MS (Multiple Sclerosis), run by Sheikh Shakhbout Medical City at 1 site in United Arab Emirates.
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 7 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: status not confirmed, as of the sponsor's last update on 18 Jan 2024. 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 United Arab Emirates. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naji J Riachi, MD (+971 2 314 4444 ext. 2979, nriachi@ssmc.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscular Oxygenation using Near-infrared spectroscopy (NIRS) Measurements (time frame: To be assessed at baseline, week 2, week 4 and week 8). 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?
On the ClinicalTrials.gov record for NCT05912595, which also lists 69 linked publications.
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 18 Jan 2024.