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

Not Applicable

Recruiting

• Conditions: Healthy Volunteers; Stroke; Cramp; Restless Legs Syndrome
• Interventions: Other: wide pulse high frequency neuromuscular electrical stimulation training

• Registration Number: NCT05908214
• Lead Sponsor: University of Lausanne

Brief Summary

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. The investigators will then use WPHF NMES as a training modality to improve plantar flexor neuromuscular function in stroke patients by taking advantage of their motoneuronal hyperexcitability.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-06-08
• Study First Posted: 2023-06-18
• Study Start: 2023-10-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stroke patients - training group	wide pulse high frequency neuromuscular electrical stimulation training	Participants in this group will take part in a 6-week WPHF NMES training period and plantar flexor neuromuscular function will be assessed before and after training.

Primary Outcome Measures

Name	Time	Method
Change in maximal voluntary contraction force	through study completion, an average of 8 weeks	Change from baseline maximal voluntary contraction force after the six-week training period in stroke patients
Estimates of persistent inward current (Delta F assessed with high-density surface electromyography and/ or the torque measured during vibration after the last bout of NMES)	through study completion, an average of 8 weeks	comparison of estimates of persistent inward current strength in plantar flexor muscles between patients (prone to cramps or restless legs) and healthy volunteers
Change in NMES-evoked force	through study completion, an average of 8 weeks	Change from baseline NMES-evoked force after the six-week training period
Change in estimates of persistent inward current (Delta F assessed with high-density surface electromyography and/ or the torque measured during vibration after the last bout of NMES)	through study completion, an average of 8 weeks	Change from baseline estimates of persistent inward current after the six-week training period in stroke patients
NMES-evoked force	through study completion, an average of 2 weeks	Comparison of NMES-evoked force in plantar flexor muscles between patients (prone to cramps or restless legs) and healthy volunteers

Secondary Outcome Measures

Name	Time	Method
Change in spinal excitability in stroke patients	through study completion, an average of 8 weeks	change from baseline soleus Hoffmann reflex amplitude after the six-week training period in stroke patients
Spinal excitability	through study completion, an average of 2 weeks	comparison of soleus Hoffmann reflex amplitude between patients (prone to cramps or restless legs) and healthy volunteers
Change in voluntary activation level and contractile properties of the plantar flexor muscles	through study completion, an average of 8 weeks	Change from baseline voluntary activation level and contractile properties of the plantar flexor muscles after the six-week training period in stroke patients
10-m walking test (s)	through study completion, an average of 8 weeks	functional test
voluntary activation level and contractile properties of the plantar flexor muscles	through study completion, an average of 2 weeks	comparison of voluntary activation level and contractile properties of the plantar flexor muscles between patients (prone to cramps or restless legs) and healthy volunteers
6-min walking test (m)	through study completion, an average of 8 weeks	functional test
time up and go test (s)	through study completion, an average of 8 weeks	functional test
change in spasticity at the ankle joint level for stroke patients	through study completion, an average of 8 weeks	Change from baseline Ashworth scale score (minimal score 0, maximal score 4, a higher score means a worst outcome) after the six-week training period in stroke patients
Cramp threshold frequency (CTF) for cramp-prone individuals	through study completion, an average of 2 weeks	comparison between participants reporting muscle cramps and healthy volunteers

Trial Locations

Locations (1)

Bâtiment Synathlon, quartier UNIL-Centre; 🇨🇭 Lausanne, Switzerland