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New treatment option for Stroke
Official title The Application of Wide Pulse High Frequency Neuromuscular Electrical Stimulation in Disorders Associated With Motoneuron Hyperexcitability
ClinicalTrials.gov ID: NCT05908214
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Inadequate ankle control during gait defined as ankle dorsiflexion less than 5° during stance phase and 0° during swing phase; 0° = ankle neutral...
- Passive range of motion of ankle dorsiflexion at least to neutral position
- Ability to walk at least 10 m with or without assistive devices
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lausanne, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lausanne, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.