Cerebral PalsyEXOCEP2GERNCT05885139
Exopulse Mollii Suit, Motor Functions & CP Children With Cerebral Palsy
A study testing Exopulse Mollii Suit in people with Cerebral Palsy and Spasticity, run by Exoneural Network AB at 2 sites in Germany.
Trial summary
Cerebral Palsy (CP) is is estimated to be around 1.5-3 per live birth, with prenatal factors accounting for 75% of cases. CP appears in early childhood and persists with age and is characterized by permanent lesions or abnormalities affecting the immature brain. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy, Spasticity, Muscle
- 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
- 34 participants
- Where
- 2 sitesGermany
- Study dates
- 17 Apr 2023to 31 Dec 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients will be included if they
- are between 5 and 12 years of age.
- have a clinical diagnosis of unilateraal or bilateral spastic CP by birth [15].
- have a PBS score between a minimum of 15 and a maxmimum of 44 points.
- are able to walk freely, with slight limitation or using ancillary equipment's (GMFCS score ≤3) [49].
- are German speakers, able to understand verbal instructions.
- have spasticity with a score of at least 1+ on the MAS
Who cannot join
- Patients will not be included if they
- are included in another research protocol during the study period.
- are unable to undergo clinical procedures for the study purposes due to geographical or social reasons.
- have a cardiac stimulator, a ventriculoperitoneal shunt, intrathecal baclofen pump.
- have a change in their pharmacological therapy over the last three months or are planning to do so during the study.
- suffer from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain).
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- have a body mass index above 35 kg/m2,
- have contraindications to wearing Exopulse Mollii Suit, receive a medical device other than Exopulse Mollii during the study period.
- have received botulinum toxin (botox) therapy in the last 3 months before the start of the study
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Medizinische Hochschule Hannover (MHH)
Hanover
Pohlig GmbH
Traunstein, Bavaria
About this study
Official title: The Effects of EXOPULSE Mollii Suit on Motor Functions in Children With Cerebral Palsy (EXOCEP 2 GER)
Cerebral Palsy (CP) is is estimated to be around 1.5-3 per live birth, with prenatal factors accounting for 75% of cases. CP appears in early childhood and persists with age and is characterized by permanent lesions or abnormalities affecting the immature brain. It mainly occurs as a motor system disorder (e.g., abnormal movements or posture) with the presence of hemiplegia, diplegia or tetraplegia, and spastic, dyskinetic or atactic syndromes. .This study will explore the potential clinical benefits of the Molliimethod in children with cerebral palsy. Spasticity impacts balance and mobility, halts the patients quality of life and their ability to perform their activity of daily living, and could also increase the risk of fractures and falls. Available interventions that aim on improving spasticity are facing limitations such as varios side effects. Therefore, developing novel therapies such as the EXOPULSE Mollii Suit could help to overcome such limitations and noninvasively improve balance, mobility, quality of life and reduce spasticity and pain in children with CP.
Read the detailed description
Cerebral Palsy is a heterogenous group of disorders that was first introduced in the literature in 1843 by Little who described musculoskeletal deformities and spastic limbs in the context of neonatal hypoxia. The clinical classification of CP could be based on several system. For instance, the classification by Balf and Ingram takes into account the type, lesion location and severity of the clinical symptoms, and entails the following CP types that could be further considered as mild, moderate or severe: diplegia, hemiplegia or tetraplegia with the presence of spastic syndromes, dyskinetic syndromes and ataxia. In the context of CP, spasticity is a frequent and debilitating symptom that could occur in 70-89% of individuals. Spasticity could subsequently alter the development of motricity, quality of life, patients' self-es-teem and seems to be associated with several health consequences, namely pain, infections, joint deformities, thrombosis and bedsores. Managing spasticity in CP include the combination of pharmacotherapy, motor rehabilitation, and surgical interventions. It is now widely accepted that spasticity impacts balance and mobility, halts the patients quality of life (e.g., urinary symptoms, sexual dysfunction, mood symptoms, low self-esteem) and their ability to perform their activity of daily living, and could also increase the risk of fractures and falls. The available interventions targeting spasticity are faced with some limitations. For instance, botulinum toxin injection does not seem to improve motor functions and quality of life as well as available oral agents are challenged by their potential side effects. Therefore, developing novel therapies would help to overcome the actual limitations. Transcutaneous Electrical Nerve Stimulation (TENS) has proven some efficacy in spasticity management. However, one should note that practical difficulties could arise when using TENS at home or in clinical practice (i.e., correctly attaching electrodes). To overcome these limitations, the Exopulse Mollii Suit has been developed by Exoneural Network AB (initially Inerventions AB), a Swedish medtech company. It represents an innovative approach for non-invasive electrostimulation to reduce spasticity and improve motor function. Based on the theoretical and practical background outlined above, this study will explore the potential clinical benefits of the Mollii-method in children with cerebral palsy. The overall aim of this study is to evaluate the short-term impact of Exopulse Mollii Suit on balance in pediatric patients with cerebral palsy who are suffering from spasticity as well as assessing the effects of Exopulse Mollii Suit on spasticity, mobility, pain, and quality of life.
- Conditions
- Cerebral Palsy, Spasticity, Muscle, Pain Syndrome, Hemiplegia, Diplegia
- Being tested
- Exopulse Mollii Suit, Sham Exopulse Mollii Suit
- Keywords
- Exopulse, Mollii Suit, Spasticity, Neurostimulation
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity, Somatoform Disorders, Hemiplegia, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exopulse Mollii SuitDevice
Exopulse Mollii suits consists of a body Garments (Jacket and Pants) and a control unit. The body Garments (Jacket and Pants) is a suit with 58 embedded electrodes that can stimulate 40 groups of muscles, conductive wires and connectors to a detachable control unit, whose intended purpose is to transmit electric pulses from the control unit to key nerves and corresponding muscle groups throughout the body. The control unit is a battery powered electrical device which sends low intensity electric pulses through connectors to the Body Garments which in turn transmits the pulses from the connectors to key nerves and corresponding muscle groups throughout the body.
Sham Exopulse Mollii SuitDevice
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 Stimulation | Active comparator | Active sessions will last 1 hour of stimulation per day for 2 weeks. 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 Stimulation | Sham comparator | In the sham condition, subjects will be asked to wear the device for 1 hour per day for 2 weeks. During 1 hour use per day, the actual stimulation will last only 1 minute and then will shut off. Receives: Device: Sham Exopulse Mollii Suit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pediatric Balance Scale (PBS)
Pediatric patients with CP, the PBS has a minimum detectable change (MDC) of 1.59 for the total score and 0.79 (static) and 0.96 (dynamic) for the subscores. Furthermore, the PBS has a minimally clinically important difference (MCID) for the cohort mentioned of 5.83 for the otal score and 2.92 (static) and 2.92 (dynamic) for the subscores.
Measured: Visit 1 = Immediately before and after 1h stimulation; Visit 2 = 2 weeks after visit 1; Visit 3 = Immediately before and after 1h stimulation, 4 weeks after visit 1; Visit 4 = 6 weeks after visit 1
Secondary outcomes (2)
Changes in Modified Ashworth Scale (MAS)
The modified Ashworth Scale measures spasticity in patients with lesions of the Central Nervous System. It tests resistance to passive movement in a joint with varying degrees of velocity. Scores range from 0-4 with 5 choices. A score of 1 indicates no resistance, and a 5 indicates rigidity.
Measured: Visit 1 = Immediately before and after 1h stimulation; Visit 2 = 2 weeks after visit 1; Visit 3 = Immediately before and after 1h stimulation, 4 weeks after visit 1; Visit 4 = 6 weeks after visit 1
Changes in Timed Up and Go (TUG)
In the chair with his/her back against the chair back. On the command "go", the patient rises from the chair, walks 3Visit 1 = Immediately before and after first 1h stimulation; Visit 2 = 2 weeks after visit 1; Visit 3 = 4 weeks after visit 1. Immediately before and after first 1h stimulation; Visit 4 = 6 weeks after visit 1 meters at a comfortable and safe pace, turns, walks back to the chair and sits down. Timing begins at the instruction "go" and stops when the patient is seated.
Measured: Visit 1 = Immediately before and after 1h stimulation; Visit 2 = 2 weeks after visit 1; Visit 3 = Immediately before and after 1h stimulation, 4 weeks after visit 1; Visit 4 = 6 weeks after visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start17 Apr 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Active Comparator: 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. Sham Comparator: Sham In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exoneural Network AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ottobock SE & Co. KGaA, Hannover Medical School, Pohlig GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885139
- Sponsor's protocol ID
- PS00011278C-001
- Acronym
- EXOCEP2GER
- Status last verified
- Aug 2026
- First submitted
- 20 Apr 2023
- Last updated
- 5 Aug 2026
- 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 5 Aug 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 Children With Cerebral Palsy (EXOCEP 2 GER)
- ClinicalTrials.gov ID
- NCT05885139
- Acronym / sponsor ID
- EXOCEP2GER / PS00011278C-001
- Conditions
- Cerebral Palsy, Spasticity, Muscle, Pain Syndrome, Hemiplegia, Diplegia
- Keywords
- Exopulse, Mollii Suit, Spasticity, Neurostimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Exoneural Network ABIndustry (pharma, biotech, devices)
- Collaborators
- Ottobock SE & Co. KGaA, Hannover Medical School, Pohlig GmbH
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 1 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.
Cerebral Palsy (CP) is is estimated to be around 1.5-3 per live birth, with prenatal factors accounting for 75% of cases. CP appears in early childhood and persists with age and is characterized by permanent lesions or abnormalities affecting the immature brain. It mainly occurs as a motor system disorder (e.g., abnormal movements or posture) with the presence of hemiplegia, diplegia or tetraplegia, and spastic, dyskinetic or atactic syndromes. .This study will explore the potential clinical benefits of the Molliimethod in children with cerebral palsy. Spasticity impacts balance and mobility, halts the patients quality of life and their ability to perform their activity of daily living, and could also increase the risk of fractures and falls. Available interventions that aim on improving spasticity are facing limitations such as varios side effects. Therefore, developing novel therapies such as the EXOPULSE Mollii Suit could help to overcome such limitations and noninvasively improve balance, mobility, quality of life and reduce spasticity and pain in children with CP.
Detailed description
Cerebral Palsy is a heterogenous group of disorders that was first introduced in the literature in 1843 by Little who described musculoskeletal deformities and spastic limbs in the context of neonatal hypoxia. The clinical classification of CP could be based on several system. For instance, the classification by Balf and Ingram takes into account the type, lesion location and severity of the clinical symptoms, and entails the following CP types that could be further considered as mild, moderate or severe: diplegia, hemiplegia or tetraplegia with the presence of spastic syndromes, dyskinetic syndromes and ataxia. In the context of CP, spasticity is a frequent and debilitating symptom that could occur in 70-89% of individuals. Spasticity could subsequently alter the development of motricity, quality of life, patients' self-es-teem and seems to be associated with several health consequences, namely pain, infections, joint deformities, thrombosis and bedsores. Managing spasticity in CP include the combination of pharmacotherapy, motor rehabilitation, and surgical interventions. It is now widely accepted that spasticity impacts balance and mobility, halts the patients quality of life (e.g., urinary symptoms, sexual dysfunction, mood symptoms, low self-esteem) and their ability to perform their activity of daily living, and could also increase the risk of fractures and falls. The available interventions targeting spasticity are faced with some limitations. For instance, botulinum toxin injection does not seem to improve motor functions and quality of life as well as available oral agents are challenged by their potential side effects. Therefore, developing novel therapies would help to overcome the actual limitations. Transcutaneous Electrical Nerve Stimulation (TENS) has proven some efficacy in spasticity management. However, one should note that practical difficulties could arise when using TENS at home or in clinical practice (i.e., correctly attaching electrodes). To overcome these limitations, the Exopulse Mollii Suit has been developed by Exoneural Network AB (initially Inerventions AB), a Swedish medtech company. It represents an innovative approach for non-invasive electrostimulation to reduce spasticity and improve motor function. Based on the theoretical and practical background outlined above, this study will explore the potential clinical benefits of the Mollii-method in children with cerebral palsy. The overall aim of this study is to evaluate the short-term impact of Exopulse Mollii Suit on balance in pediatric patients with cerebral palsy who are suffering from spasticity as well as assessing the effects of Exopulse Mollii Suit on spasticity, mobility, pain, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Active Comparator: 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. Sham Comparator: Sham In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation | Active comparator | Device: Exopulse Mollii SuitActive sessions will last 1 hour of stimulation per day for 2 weeks. 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 Stimulation | Sham comparator | Device: Sham Exopulse Mollii SuitIn the sham condition, subjects will be asked to wear the device for 1 hour per day for 2 weeks. During 1 hour use per day, the actual stimulation will last only 1 minute and then will shut off. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patients will be included if they
- are between 5 and 12 years of age.
- have a clinical diagnosis of unilateraal or bilateral spastic CP by birth [15].
- have a PBS score between a minimum of 15 and a maxmimum of 44 points.
- are able to walk freely, with slight limitation or using ancillary equipment's (GMFCS score ≤3) [49].
Key exclusion criteria (9 listed)
- Patients will not be included if they
- are included in another research protocol during the study period.
- are unable to undergo clinical procedures for the study purposes due to geographical or social reasons.
- have a cardiac stimulator, a ventriculoperitoneal shunt, intrathecal baclofen pump.
- have a change in their pharmacological therapy over the last three months or are planning to do so during the study.
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 suits consists of a body Garments (Jacket and Pants) and a control unit. The body Garments (Jacket and Pants) is a suit with 58 embedded electrodes that can stimulate 40 groups of muscles, conductive wires and connectors to a detachable control unit, whose intended purpose is to transmit electric pulses from the control unit to key nerves and corresponding muscle groups throughout the body. The control unit is a battery powered electrical device which sends low intensity electric pulses through connectors to the Body Garments which in turn transmits the pulses from the connectors to key nerves and corresponding muscle groups throughout the body. | Device | Active Stimulation |
| Sham Exopulse Mollii SuitIn the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off. | Device | Sham Stimulation |
Primary outcome
Changes in Pediatric Balance Scale (PBS)
Time frame: Visit 1 = Immediately before and after 1h stimulation; Visit 2 = 2 weeks after visit 1; Visit 3 = Immediately before and after 1h stimulation, 4 weeks after visit 1; Visit 4 = 6 weeks after visit 1
Pediatric patients with CP, the PBS has a minimum detectable change (MDC) of 1.59 for the total score and 0.79 (static) and 0.96 (dynamic) for the subscores. Furthermore, the PBS has a minimally clinically important difference (MCID) for the cohort mentioned of 5.83 for the otal score and 2.92 (static) and 2.92 (dynamic) for the subscores.
2 secondary outcomes
Changes in Modified Ashworth Scale (MAS)
Time frame: Visit 1 = Immediately before and after 1h stimulation; Visit 2 = 2 weeks after visit 1; Visit 3 = Immediately before and after 1h stimulation, 4 weeks after visit 1; Visit 4 = 6 weeks after visit 1
Changes in Timed Up and Go (TUG)
Time frame: Visit 1 = Immediately before and after 1h stimulation; Visit 2 = 2 weeks after visit 1; Visit 3 = Immediately before and after 1h stimulation, 4 weeks after visit 1; Visit 4 = 6 weeks after visit 1
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 5 Aug 2026.
- 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.
2 sites 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 Cerebral Palsy and Spasticity, run by Exoneural Network AB at 2 sites in Germany.
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 9 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 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 Pediatric Balance Scale (PBS) (time frame: Visit 1 = Immediately before and after 1h stimulation; Visit 2 = 2 weeks after visit 1; Visit 3 = Immediately before and after 1h stimulation, 4 weeks after visit 1; Visit 4 = 6 weeks after visit 1). 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 5 Aug 2026.