Using electrical stimulation to improve muscle function in stroke patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project investigates the use of wide pulse high frequency neuromuscular electrical stimulation (WPHF NMES) to address motoneuron hyperexcitability and its associated impairments in conditions like stroke, muscle cramps, and restless legs syndrome. The study aims to understand the underlying mechanisms of these conditions and utilize WPHF NMES as a training method to enhance neuromuscular function in stroke patients. Participants will undergo electrical stimulation training to improve their ankle control and overall mobility.

Why it matters

Who can join: the full rules

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

Where it's running

• Bâtiment Synathlon, quartier UNIL-Centre
  Lausanne, Switzerland Recruiting

Study contacts

• Study coordinator: Nicolas Place, PhD
• Email: nicolas.place@unil.ch
• Phone: +41216923806

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Deep phenotyping to explore recovery in young adults after stroke

  This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.

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• Stem cell therapy for chronic stroke recovery

  This study is testing whether using a patient's own stem cells can help people with long-term stroke recovery feel better and improve their daily functioning.

  Recruiting Phase 2 Hokkaido University Hospital · Sapporo, Hokkaido · NCT06752720

• AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

  This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.

  Recruiting at 2 sites Hospital Universitari Vall d'Hebron Research Institute · Leuven and 6 other locations · NCT07924371

• Web-based therapy using action observation and mirror therapy for arm weakness after stroke

  This trial tests whether a mobile telerehabilitation app delivering action observation therapy (AOT) alone or combined AOT with mirror therapy (AOT-MT) can improve upper limb function in people with subacute stroke.

  Recruiting Chang Gung Memorial Hospital · Taoyuan · NCT07921108

• Remote Ischaemic Conditioning for Fatigue After Stroke 2

  Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.

  Recruiting Phase 2 Sheffield Teaching Hospitals NHS Foundation Trust · Sheffield, South Yorkshire · NCT07914647

• Dual-task balance training plus computer-based cognitive training after stroke

  In adults who recently had a stroke, the study tests whether adding computerized cognitive exercises to balance training improves balance and other recovery outcomes.

  Recruiting Matia Foundation · San Sebastián, GUIPUZCOA · NCT07913620

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.