Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05908214

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

Led by University of Lausanne · Updated on 2023-11-28

110

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University of Lausanne

Lead Sponsor

S

Swiss National Science Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are exploring new ways to study spinal motoneuron overactivity, which can cause problems like muscle cramps, restless legs syndrome, and spasticity after stroke. This project aims to understand these conditions better by using wide pulse high frequency neuromuscular electrical stimulation (WPHF NMES) as a model. The study also investigates using this stimulation as a training method to improve muscle function in stroke patients. Participants will be divided into two groups: one will undergo a 6-week training program using WPHF NMES on the plantar flexor muscles three times a week, while the other group will continue their usual daily activities without intervention. Muscle function will be measured before and after the training period to assess changes. During the study, researchers will evaluate muscle strength, electrical activity, and muscle control using various tests such as maximal voluntary contraction force, NMES-evoked force, and electromyography over an average of 8 weeks. Additional assessments include walking tests and spasticity measures in stroke patients. The study also monitors muscle cramp thresholds and spinal excitability to understand treatment effects and muscle function changes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosis of first-ever stroke with unilateral motor deficits present for at least 6 months
  • Inadequate ankle control during walking defined by specific ankle dorsiflexion limits
  • Passive ankle dorsiflexion range of motion at least to neutral position
  • Ability to walk at least 10 meters with or without assistive devices
  • Spasticity in triceps surae muscles with Modified Ashworth Score of 1 or higher
  • Willingness and availability to participate for the study period
  • No contraindications to neuromuscular electrical stimulation
  • Reporting nocturnal muscle cramps without current treatment (for cramp-prone individuals)
  • Diagnosis of primary restless legs syndrome meeting International Restless Legs Syndrome Study Group criteria
  • For healthy participants, absence of neurological disease
  • Willingness and availability to participate for the study period
Not Eligible

You will not qualify if you...

  • Sensory loss in affected lower leg preventing sensation of 60-g touch
  • Inability to understand study instructions or provide informed consent
  • History of orthopedic or neurological disorders affecting walking
  • Previous surgery for drop foot correction
  • Use of antispastic medication (baclofen, tizanidine, tolperisone, benzodiazepines, dantrolene, botulinum toxin) in the past 6 months
  • Current treatment for muscle cramps
  • Symptoms explained by other medical or behavioral conditions such as leg cramps or habitual foot tapping
  • Profound daytime sleepiness (for restless legs syndrome patients)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 weeks

Participants receive wide pulse high frequency neuromuscular electrical stimulation training on the plantar flexors.

3 visits per week (in-person or supervised sessions)

Follow-up

Duration - Up to 2 weeks

Participants are assessed for changes in neuromuscular function and motor performance after the treatment period.

1 to 2 visits depending on assessments

Trial Site Locations

Total: 1 location

1

Bâtiment Synathlon, quartier UNIL-Centre

Lausanne, Switzerland, 1015

Actively Recruiting

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Research Team

N

Nicolas Place, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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