Spasticity as Sequela of StrokeEXOSTROKENCT06702163
EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE)
A study testing EXOPULSE MOLLII SUIT (active) in people with Spasticity as Sequela of Stroke, run by Institut De La Colonne Vertebrale Et Des Neurosciences at 1 site in France.
Trial summary
Spasticity is a common and debilitating complication in neurological conditions such as multiple sclerosis, cerebral palsy, and stroke. Stroke, a leading cause of global disability and death, occurs when blood flow to the brain is disrupted, causing neuronal damage. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spasticity as Sequela of Stroke
- What is being tested?
- EXOPULSE MOLLII SUIT (active)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2022to 17 Apr 2025
- 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
- Age between 18 and 75 years.
- Having a clinical diagnosis of stroke for at least three months.
- Being able to walk freely or with the need of support (modified Rankin score
- 4).
- Being a French speaker, able to understand verbal instructions, and affiliated. with the national health insurance (sécurité social).
- Having spasticity with a score of at least 1+ on the MAS.
- Having a Berg Balance Scale score ≤46 associated across the literature with a risk of fall.
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 contraindications for using EXOPULSE Mollii suit (having implanted electronic medical devices or equipment which can be disrupted by magnets or an electronic life support equipment or high-frequency operation equipment; e.g., cardiac stimulator, ventriculoperitoneal shunt, intrathecal baclofen pump).
- Being pregnant (confirmed by a blood beta-HCG test).
- 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 introducing 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 ")
- Patients deprived of freedom (" personnes privées de liberté ".)
Trial locations and contacts
1 site in 1 country.
France1 site
Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France
Créteil, VAL DE MARNE, 94000
About this study
Official title: The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients With Stroke (EXOSTROKE)
Spasticity is a common and debilitating complication in neurological conditions such as multiple sclerosis, cerebral palsy, and stroke. Stroke, a leading cause of global disability and death, occurs when blood flow to the brain is disrupted, causing neuronal damage. Approximately 80% of strokes are ischemic, with 20% being hemorrhagic. Several factors, including age, sex, vascular conditions, and lifestyle choices, increase the risk of stroke. Spasticity affects 19-28% of stroke survivors in the short term and up to 46% in the long term, severely impacting mobility and quality of life. Management typically involves pharmacological and nonpharmacological interventions, though these often have limited effectiveness and side effects. In this context, non-invasive techniques like transcutaneous stimulation with the EXOPULSE Mollii suit may offer a valuable alternative for managing spasticity and its associated symptoms.
- Conditions
- Spasticity as Sequela of Stroke
- Being tested
- EXOPULSE MOLLII SUIT (active), EXOPULSE MOLLII SUIT (sham)
- Keywords
- EXOPULSE Mollii Suit, Motor Functions & Stroke, Spasticity
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXOPULSE MOLLII SUIT (active)Device
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 several 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 |
|---|---|---|
| Experimental Condition | 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. These parameters were previously found to be safe in human studies. Based on the clinical exam of each patient, the spastic muscles will be targeted.
EXOPULSE Mollii Suit is used for activation of weak muscles or relaxation of spastic muscles mediated by a physiological reflex mechanism referred to as reciprocal inhibition. By sending an electrical signal to an antagonistic muscle, the spastic muscle will subsequently relax. Receives: Device: EXOPULSE MOLLII SUIT (active) |
| Control Condition | Sham comparator | In the control condition, the patients will receive a sham stimulation, for which the control unit will be programmed to start stimulating for 1 minute then it will shut off. There is no risk related to the sham intervention since it consists of applying the same parameters used for the active session (low frequency: 20 Hz; current intensity: 2 mA; pulse width ranging from 25 to 170 µs) but for a shorter duration of time (1 minute instead of 1 hour). Receives: Device: EXOPULSE MOLLII SUIT (sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in balance using the BBS (Berg Balance Scale) ) before and after active and sham stimulation
Balance will be assessed using the 14-item BBS which has good psychometric properties in patients with stroke. The scale rates the balance using 56 points, with higher scores indicating better balance abilities. A score equal to or below 45 is commonly associated with the risk of falls across the literature.
Measured: This will be assessed before and after each condition (phase 1, 1 session per condition sham or active stimulation) on Day 0 (Visit1), Day 15 (Visit2), Day 30 (Visit3) and Day 45 (Visit4)
Secondary outcomes (8)
Assessment of the cumulative effects of EXOPULSE Mollii suit on balance using the BBS (Berg Balance Scale)
The cumulative effects of EXOPULSE Mollii Suit will be assessed following 4 weeks of using the device (3-4 times per week, during the open-label phase 2)
Measured: Evaluation will occur before Visit 5 (Day 60) and after Visit 6 (Day 90) 4 weeks of using EXOPULSE Mollii suit
Assessment of the spasticity using the MAS (Modified Ashworth Scale) and the VAS pain (Visual Analogue Scale)
Spasticity will be evaluated by examiners using the MAS (Modified Ashworth Scale) and by patients using a VAS (Visual Analogue Scale)
Measured: This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)
Mobility will be assessed using the TUG scale (Time Up and Go)
TUG (Time Up and Go)is a validated test in patients with stroke. The score is expressed as the time (in seconds) required to perform sequential motor tasks (standing up from the chair, walking to the line on the floor at a normal pace, turning, walking back to the chair at a normal pace and finally sitting down).
Measured: This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)
Mobility will be assessed using the FES-I (Falls Efficacy Scale-International scale)
Subjective risk of fall will be assessed 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: Evaluation will occur before Visit 5 (Day 60) and after Visit 6 (Day 90) 4 weeks of using EXOPULSE Mollii suit (Phase 2)
Quality of life will be measured using the EQ-5D-5L (EuroQol 5 Dimensions 5 Levels Quality of Life Questionnaire)
This variable will be measured using the EuroQol 5 dimensions quality of life questionnaire, a scale developed by EuroQoL group. This scale has good psychometric properties in stroke and seems to be the most used generic health status questionnaire in this population. The 5 levels version (EQ-5D-5L) will be adopted in this work. The scale evaluates five dimensions: anxiety/depression, mobility, pain/difficulty, self-care, and usual activities.
Measured: Evaluation will occur before Visit 5 (Day 60) and after Visit 6 (Day 90) 4 weeks of using EXOPULSE Mollii suit (Phase 2)
Pain and fatigue will be assessed using a VAS (Visual Analogue Scale)
The visual analog scale for pain is a 10 mm straight line with one end meaning no pain and the other end meaning the worst pain imaginable
Measured: This will be assessed through study completion, an average of 3 months (at Visit 1, V2, V3, V4, V5 and V6)
Evaluation of overall improvement using the CGI (Clinical Global Impression)
It consists of 7-point scale ranging from "very much improved since the initiation of treatment" to "very much worse since the initiation of treatment" (from 1 to 7)
Measured: This will be assessed at Visit2 (Day 15) , Visit4 (Day 45) and Visit6 (Day 90) since CGI is designed to be applied after interventions
Evaluation of patient's blinding to the type of stimulation in the crossover trial
This blind evaluation will be done in phase 1 using a dedicated questionnaire (only at visits 2 and 4 after each condition, as all patients will receive the same active treatment during open-label phase 2).
Measured: This will only be assessed at Visit2 (Day 15) and Visit4 (Day 45) since it's designed to be applied after interventions of phase 1 (double blind phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start20 Dec 2022
- Primary completion2 Apr 2025
- Study completion17 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity as Sequela of StrokeStudies 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
- Model description
- We designed a randomized crossover, sham-controlled, double blind trial to demonstrate the improvement of motor functions and stroke related 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. Two weeks after the end of this phase (phase 1), a second phase of this trial, an open label phase, will be proposed for all patients to understand the effects of EXOPULSE Mollii suit employed over 4 weeks (a session every other day for a total of 14 sessions) on stroke related symptoms. Summary: * Phase 1: randomized sham-controlled crossover study (active versus sham condition) * Phase 2: Open-label study (active condition)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut De La Colonne Vertebrale Et Des Neurosciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samar S AYACHE, MD, PhD, Principal investigator, Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702163
- Sponsor's protocol ID
- 2022-A00232-41
- Acronym
- EXOSTROKE
- Status last verified
- Feb 2026
- First submitted
- 3 Nov 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients With Stroke (EXOSTROKE)
- ClinicalTrials.gov ID
- NCT06702163
- Acronym / sponsor ID
- EXOSTROKE / 2022-A00232-41
- Conditions
- Spasticity as Sequela of Stroke
- Keywords
- EXOPULSE Mollii Suit, Motor Functions & Stroke, Spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institut De La Colonne Vertebrale Et Des NeurosciencesUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 17 Apr 2025 (actual)
- First posted
- 22 Nov 2024 (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 common and debilitating complication in neurological conditions such as multiple sclerosis, cerebral palsy, and stroke. Stroke, a leading cause of global disability and death, occurs when blood flow to the brain is disrupted, causing neuronal damage. Approximately 80% of strokes are ischemic, with 20% being hemorrhagic. Several factors, including age, sex, vascular conditions, and lifestyle choices, increase the risk of stroke. Spasticity affects 19-28% of stroke survivors in the short term and up to 46% in the long term, severely impacting mobility and quality of life. Management typically involves pharmacological and nonpharmacological interventions, though these often have limited effectiveness and side effects. In this context, non-invasive techniques like transcutaneous stimulation with the EXOPULSE Mollii suit may offer a valuable alternative for managing spasticity and its associated symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- We designed a randomized crossover, sham-controlled, double blind trial to demonstrate the improvement of motor functions and stroke related 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. Two weeks after the end of this phase (phase 1), a second phase of this trial, an open label phase, will be proposed for all patients to understand the effects of EXOPULSE Mollii suit employed over 4 weeks (a session every other day for a total of 14 sessions) on stroke related symptoms. Summary: * Phase 1: randomized sham-controlled crossover study (active versus sham condition) * Phase 2: Open-label study (active condition)
| Arm | Type | Receives |
|---|---|---|
| Experimental Condition | Active comparator | Device: EXOPULSE MOLLII SUIT (active)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. These parameters were previously found to be safe in human studies. Based on the clinical exam of each patient, the spastic muscles will be targeted. EXOPULSE Mollii Suit is used for activation of weak muscles or relaxation of spastic muscles mediated by a physiological reflex mechanism referred to as reciprocal inhibition. By sending an electrical signal to an antagonistic muscle, the spastic muscle will subsequently relax. |
| Control Condition | Sham comparator | Device: EXOPULSE MOLLII SUIT (sham)In the control condition, the patients will receive a sham stimulation, for which the control unit will be programmed to start stimulating for 1 minute then it will shut off. There is no risk related to the sham intervention since it consists of applying the same parameters used for the active session (low frequency: 20 Hz; current intensity: 2 mA; pulse width ranging from 25 to 170 µs) but for a shorter duration of time (1 minute instead of 1 hour). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 75 years.
- Having a clinical diagnosis of stroke for at least three months.
- Being able to walk freely or with the need of support (modified Rankin score
- Being a French speaker, able to understand verbal instructions, and affiliated. with the national health insurance (sécurité social).
- 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 contraindications for using EXOPULSE Mollii suit (having implanted electronic medical devices or equipment which can be disrupted by magnets or an electronic life support equipment or high-frequency operation equipment; e.g., cardiac stimulator, ventriculoperitoneal shunt, intrathecal baclofen pump).
- Being pregnant (confirmed by a blood beta-HCG test).
- 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 (active)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 several 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 | Experimental Condition |
| 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 | Control Condition |
Primary outcome
Improvement in balance using the BBS (Berg Balance Scale) ) before and after active and sham stimulation
Time frame: This will be assessed before and after each condition (phase 1, 1 session per condition sham or active stimulation) on Day 0 (Visit1), Day 15 (Visit2), Day 30 (Visit3) and Day 45 (Visit4)
Balance will be assessed using the 14-item BBS which has good psychometric properties in patients with stroke. The scale rates the balance using 56 points, with higher scores indicating better balance abilities. A score equal to or below 45 is commonly associated with the risk of falls across the literature.
8 secondary outcomes
Assessment of the cumulative effects of EXOPULSE Mollii suit on balance using the BBS (Berg Balance Scale)
Time frame: Evaluation will occur before Visit 5 (Day 60) and after Visit 6 (Day 90) 4 weeks of using EXOPULSE Mollii suit
Assessment of the spasticity using the MAS (Modified Ashworth Scale) and the VAS pain (Visual Analogue Scale)
Time frame: This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)
Mobility will be assessed using the TUG scale (Time Up and Go)
Time frame: This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)
Mobility will be assessed using the FES-I (Falls Efficacy Scale-International scale)
Time frame: Evaluation will occur before Visit 5 (Day 60) and after Visit 6 (Day 90) 4 weeks of using EXOPULSE Mollii suit (Phase 2)
Quality of life will be measured using the EQ-5D-5L (EuroQol 5 Dimensions 5 Levels Quality of Life Questionnaire)
Time frame: Evaluation will occur before Visit 5 (Day 60) and after Visit 6 (Day 90) 4 weeks of using EXOPULSE Mollii suit (Phase 2)
Pain and fatigue will be assessed using a VAS (Visual Analogue Scale)
Time frame: This will be assessed through study completion, an average of 3 months (at Visit 1, V2, V3, V4, V5 and V6)
Evaluation of overall improvement using the CGI (Clinical Global Impression)
Time frame: This will be assessed at Visit2 (Day 15) , Visit4 (Day 45) and Visit6 (Day 90) since CGI is designed to be applied after interventions
Evaluation of patient's blinding to the type of stimulation in the crossover trial
Time frame: This will only be assessed at Visit2 (Day 15) and Visit4 (Day 45) since it's designed to be applied after interventions of phase 1 (double blind phase)
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 27 Feb 2026.
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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.
Samar S AYACHE, MD, PhD principal investigator
Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France
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 (active) in people with Spasticity as Sequela of Stroke, 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 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: finished, as of the sponsor's last update on 27 Feb 2026. 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?
Improvement in balance using the BBS (Berg Balance Scale) ) before and after active and sham stimulation (time frame: This will be assessed before and after each condition (phase 1, 1 session per condition sham or active stimulation) on Day 0 (Visit1), Day 15 (Visit2), Day 30 (Visit3) and Day 45 (Visit4)). 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 27 Feb 2026.