The Application of Wide Pulse High Frequency Neuromuscular Electrical Stimulation in Disorders Associated With Motoneuron Hyperexcitability

Launched by UNIVERSITY OF LAUSANNE · Jun 8, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment method called Wide Pulse High Frequency Neuromuscular Electrical Stimulation (WPHF NMES) to help people with certain conditions like stroke, muscle cramps, and restless legs syndrome. The goal is to understand how this treatment can improve muscle function and reduce symptoms associated with these conditions. The researchers believe that the issues related to muscle cramps, restless legs, and stroke may have similar underlying causes, and they aim to use WPHF NMES to provide relief and improve movement.

To participate in this study, you might be eligible if you are a stroke patient who has had a stroke for at least six months and has difficulty controlling your ankle movement, or if you experience frequent muscle cramps or have restless legs syndrome. Healthy volunteers who do not have any neurological diseases can also join. Participants can expect to receive the WPHF NMES treatment during the study and be evaluated for how it affects their muscle function and symptoms. The trial is currently recruiting participants, and anyone interested should be willing to commit to the study period and not have any health issues that would make this treatment unsafe for them.

Gender

ALL

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 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:
• • 1. The presence of periodic limb movements
• • 2. A dopaminergic treatment response
• • 3. The presence of RLS in first-degree relatives
• • 4. 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