StrokeMnHyperexNCT05908214
The Application of Wide Pulse High Frequency Neuromuscular Electrical Stimulation in Disorders Associated With Motoneuron Hyperexcitability
A study testing wide pulse high frequency neuromuscular electrical stimulation training in people with Stroke and Cramp, run by University of Lausanne at 1 site in Switzerland.
Trial summary
In the present project, the investigators aim at proposing innovative ways of investigating spinal motoneuron hyperexcitability to counteract the associated impairments by using wide pulse high frequency neuromuscular electrical stimulation (WPHF NMES) in various populations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Cramp, Restless Legs Syndrome
- What is being tested?
- wide pulse high frequency neuromuscular electrical stimulation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
STROKE PATIENTS:
- Diagnosis of first-ever stroke (ischemic or hemorrhagic) with unilateral motor deficits from at least 6 months. Stroke will have to be confirmed from medical records and/or radiological imaging (CT scan or MRI)
- Inadequate ankle control during gait defined as ankle dorsiflexion less than 5° during stance phase and 0° during swing phase; 0° = ankle neutral position)
- Passive range of motion of ankle dorsiflexion at least to neutral position
- Ability to walk at least 10 m with or without assistive devices
- Spasticity at the triceps surae (either soleus and/or gastrocnemii) considered as a Modified Ashworth Sore ≥1
- Being available for the study period and willing to participate
- No contraindication to neuromuscular electrical stimulation
Contraindications for stroke patients:
- Surface sensory loss of affected lower leg (defined as incapacity to feel the 60-g touch using the Semmes-Weinstein monofilament test)
- Patients unable to understand indications or to provide informed consent
- A history of orthopedic or other neurological disorders affecting walking function
- A history of surgery to correct drop foot (ankle fixation)
- Patients under antispastic medication (baclofen, tizanidine, tolperisone, benzodiazepines, dantrolene or botulinum toxin to the plantar flexor muscles in the last 6 months).
PEOPLE PRONE TO MUSCLE CRAMPS:
- Reporting nocturnal muscle cramps (the assessment will be done through a questionnaire)
- Not being treated for muscle cramps
- Being available for the study period and willing to participate
- No contraindication to neuromuscular electrical stimulation
PATIENTS WITH RESTLESS LEGS SYNDROME:
To be included in the study, RLS patients will have to satisfy the Diagnostic criteria for RLS published by the International Restless Legs Syndrome StudyGroup (IRLSSG). All five key clinical features are required for the diagnosis:
- An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. Sometimes the urge to move is present without the uncomfortable sensations, and sometimes the arms or other body parts are involved in addition to the legs.
- The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.
- The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues.
- The urge to move or unpleasant sensations are worse in the evening or night than during the day, or only occur in the evening or night. When symptoms are severe, the worsening at night may not be noticeable but must have been previously present.
- Symptoms are not solely accounted for by another medical or behavioral condition, such as leg cramps or habitual foot tapping.
- No contraindication to neuromuscular electrical stimulation
They will also have to satisfy the following criteria:
- Diagnosis of primary RLS corresponding to:
- The presence of periodic limb movements
- A dopaminergic treatment response
- The presence of RLS in first-degree relatives
- A lack of profound daytime sleepiness
- Being available for the study period and willing to participate
HEALTHY PARTICIPANTS:
- No neurological disease
- No contraindication to neuromuscular electrical stimulation
- Being available for the study period and willing to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Bâtiment Synathlon, quartier UNIL-Centre
Lausanne, 1015
Nicolas Place, PhD, 0216923806, nicolas.place@unil.ch
About this study
In the present project, the investigators aim at proposing innovative ways of investigating spinal motoneuron hyperexcitability to counteract the associated impairments by using wide pulse high frequency neuromuscular electrical stimulation (WPHF NMES) in various populations. The investigators will use WPHF NMES contractions as a model to gain insights into the mechanisms underlying muscle cramps, restless legs syndrome or stroke-induced spasticity as there is evidence that they share common underlying mechanisms. The investigators will then use WPHF NMES as a training modality to improve plantar flexor neuromuscular function in stroke patients by taking advantage of their motoneuronal hyperexcitability.
- Conditions
- Stroke, Cramp, Restless Legs Syndrome, Healthy Volunteers
- Being tested
- wide pulse high frequency neuromuscular electrical stimulation training
- Keywords
- muscle strength, persistent inward current, training
- Medical subject headings
- Stroke, Muscle Cramp, Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wide pulse high frequency neuromuscular electrical stimulation trainingOther
Plantar flexors will be stimulated with wide pulse high frequency neuromuscular electrical stimulation 3 times a week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients - training group | Experimental | Participants in this group will take part in a 6-week WPHF NMES training period and plantar flexor neuromuscular function will be assessed before and after training. Receives: Other: wide pulse high frequency neuromuscular electrical stimulation training |
| stroke patients - control group | No intervention | Participants in this group will keep their daily life activities for 6 weeks and plantar flexor neuromuscular function will be assessed before and after training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal voluntary contraction force
Change from baseline maximal voluntary contraction force after the six-week training period in stroke patients
Measured: through study completion, an average of 8 weeks
Change in NMES-evoked force
Change from baseline NMES-evoked force after the six-week training period
Measured: through study completion, an average of 8 weeks
NMES-evoked force
Comparison of NMES-evoked force in plantar flexor muscles between patients (prone to cramps or restless legs) and healthy volunteers
Measured: through study completion, an average of 2 weeks
Change in estimates of persistent inward current (Delta F assessed with high-density surface electromyography and/ or the torque measured during vibration after the last bout of NMES)
Change from baseline estimates of persistent inward current after the six-week training period in stroke patients
Measured: through study completion, an average of 8 weeks
Estimates of persistent inward current (Delta F assessed with high-density surface electromyography and/ or the torque measured during vibration after the last bout of NMES)
comparison of estimates of persistent inward current strength in plantar flexor muscles between patients (prone to cramps or restless legs) and healthy volunteers
Measured: through study completion, an average of 8 weeks
Secondary outcomes (9)
Change in voluntary activation level and contractile properties of the plantar flexor muscles
Change from baseline voluntary activation level and contractile properties of the plantar flexor muscles after the six-week training period in stroke patients
Measured: through study completion, an average of 8 weeks
voluntary activation level and contractile properties of the plantar flexor muscles
comparison of voluntary activation level and contractile properties of the plantar flexor muscles between patients (prone to cramps or restless legs) and healthy volunteers
Measured: through study completion, an average of 2 weeks
change in spasticity at the ankle joint level for stroke patients
Change from baseline Ashworth scale score (minimal score 0, maximal score 4, a higher score means a worst outcome) after the six-week training period in stroke patients
Measured: through study completion, an average of 8 weeks
10-m walking test (s)
functional test
Measured: through study completion, an average of 8 weeks
6-min walking test (m)
functional test
Measured: through study completion, an average of 8 weeks
time up and go test (s)
functional test
Measured: through study completion, an average of 8 weeks
Change in spinal excitability in stroke patients
change from baseline soleus Hoffmann reflex amplitude after the six-week training period in stroke patients
Measured: through study completion, an average of 8 weeks
Spinal excitability
comparison of soleus Hoffmann reflex amplitude between patients (prone to cramps or restless legs) and healthy volunteers
Measured: through study completion, an average of 2 weeks
Cramp threshold frequency (CTF) for cramp-prone individuals
comparison between participants reporting muscle cramps and healthy volunteers
Measured: through study completion, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Oct 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel groups
- Model description
- Stroke patients in the training group will be compared to stroke patients in the control group. Participants prone to cramps will be compared to healthy participants. Patients with restless legs syndrome will be compared to healthy participants.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Principal investigator, Nicolas Place, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908214
- Sponsor's protocol ID
- 2022-01817
- Acronym
- MnHyperex
- Status last verified
- Nov 2023
- First submitted
- 16 May 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Wide Pulse High Frequency Neuromuscular Electrical Stimulation in Disorders Associated With Motoneuron Hyperexcitability
- ClinicalTrials.gov ID
- NCT05908214
- Acronym / sponsor ID
- MnHyperex / 2022-01817
- Conditions
- Stroke, Cramp, Restless Legs Syndrome, Healthy Volunteers
- Keywords
- muscle strength, persistent inward current, training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 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.
In the present project, the investigators aim at proposing innovative ways of investigating spinal motoneuron hyperexcitability to counteract the associated impairments by using wide pulse high frequency neuromuscular electrical stimulation (WPHF NMES) in various populations. The investigators will use WPHF NMES contractions as a model to gain insights into the mechanisms underlying muscle cramps, restless legs syndrome or stroke-induced spasticity as there is evidence that they share common underlying mechanisms. The investigators will then use WPHF NMES as a training modality to improve plantar flexor neuromuscular function in stroke patients by taking advantage of their motoneuronal hyperexcitability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stroke patients in the training group will be compared to stroke patients in the control group. Participants prone to cramps will be compared to healthy participants. Patients with restless legs syndrome will be compared to healthy participants.
| Arm | Type | Receives |
|---|---|---|
| Stroke patients - training group | Experimental | Other: wide pulse high frequency neuromuscular electrical stimulation trainingParticipants in this group will take part in a 6-week WPHF NMES training period and plantar flexor neuromuscular function will be assessed before and after training. |
| stroke patients - control group | No intervention | –Participants in this group will keep their daily life activities for 6 weeks and plantar flexor neuromuscular function will be assessed before and after training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| wide pulse high frequency neuromuscular electrical stimulation trainingPlantar flexors will be stimulated with wide pulse high frequency neuromuscular electrical stimulation 3 times a week for 6 weeks | Other | Stroke patients - training group |
Primary outcome
Change in maximal voluntary contraction force
Time frame: through study completion, an average of 8 weeks
Change from baseline maximal voluntary contraction force after the six-week training period in stroke patients
Change in NMES-evoked force
Time frame: through study completion, an average of 8 weeks
Change from baseline NMES-evoked force after the six-week training period
NMES-evoked force
Time frame: through study completion, an average of 2 weeks
Comparison of NMES-evoked force in plantar flexor muscles between patients (prone to cramps or restless legs) and healthy volunteers
Change in estimates of persistent inward current (Delta F assessed with high-density surface electromyography and/ or the torque measured during vibration after the last bout of NMES)
Time frame: through study completion, an average of 8 weeks
Change from baseline estimates of persistent inward current after the six-week training period in stroke patients
Estimates of persistent inward current (Delta F assessed with high-density surface electromyography and/ or the torque measured during vibration after the last bout of NMES)
Time frame: through study completion, an average of 8 weeks
comparison of estimates of persistent inward current strength in plantar flexor muscles between patients (prone to cramps or restless legs) and healthy volunteers
9 secondary outcomes
Change in voluntary activation level and contractile properties of the plantar flexor muscles
Time frame: through study completion, an average of 8 weeks
voluntary activation level and contractile properties of the plantar flexor muscles
Time frame: through study completion, an average of 2 weeks
change in spasticity at the ankle joint level for stroke patients
Time frame: through study completion, an average of 8 weeks
10-m walking test (s)
Time frame: through study completion, an average of 8 weeks
6-min walking test (m)
Time frame: through study completion, an average of 8 weeks
time up and go test (s)
Time frame: through study completion, an average of 8 weeks
Change in spinal excitability in stroke patients
Time frame: through study completion, an average of 8 weeks
Spinal excitability
Time frame: through study completion, an average of 2 weeks
Cramp threshold frequency (CTF) for cramp-prone individuals
Time frame: through study completion, an average of 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wide pulse high frequency neuromuscular electrical stimulation training in people with Stroke and Cramp, run by University of Lausanne at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 28 Nov 2023. 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 Switzerland. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Place, PhD (+41216923806, nicolas.place@unil.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximal voluntary contraction force (time frame: through study completion, an average of 8 weeks). The study lists 5 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 28 Nov 2023.