Clinical trial 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
- The study wants to learn how a wide‑pulse, high‑frequency electrical stimulation affects over‑active nerve cells that cause muscle cramps, restless legs, or spasticity after stroke, and whether it can help improve leg muscle function.
- Who it's for
- Adults who have had a stroke, experience muscle cramps, have restless legs syndrome, or are healthy volunteers.
- What's involved
- Participants will receive the electrical stimulation on their lower leg muscles, and researchers will measure muscle responses and function during and after the sessions.
- Time commitment
- The study lasts for several visits over a few weeks, with each visit including the stimulation session and related testing.
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
- Diagnosis of first-ever stroke (ischemic or hemorrhagic) with unilateral motor deficits from at least 6 months.
- Inadequate ankle control during gait defined as ankle dorsiflexion less than 5° during stance phase and 0° during swing phase
- 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
See the full eligibility criteria
- 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
- 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)
- 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
- An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in 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.
- Symptoms are not solely accounted for by another medical or behavioral condition, such as leg cramps or habitual foot tapping.
- The presence of periodic limb movements
- A dopaminergic treatment response
- The presence of RLS in first-degree relatives
- A lack of profound daytime sleepiness
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Lausanne, Switzerland. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.