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

Primary Purpose

Stroke, Cramp, Restless Legs Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
wide pulse high frequency neuromuscular electrical stimulation training
Sponsored by
University of Lausanne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring muscle strength, persistent inward current, training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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: The presence of periodic limb movements A dopaminergic treatment response The presence of RLS in first-degree relatives 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

Sites / Locations

  • Bâtiment Synathlon, quartier UNIL-Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stroke patients - training group

stroke patients - control group

Arm Description

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.

Participants in this group will keep their daily life activities for 6 weeks and plantar flexor neuromuscular function will be assessed before and after training.

Outcomes

Primary Outcome Measures

Change in maximal voluntary contraction force
Change from baseline maximal voluntary contraction force after the six-week training period in stroke patients
Change in NMES-evoked force
Change from baseline NMES-evoked force after the six-week training period
NMES-evoked force
Comparison of NMES-evoked force in plantar flexor muscles between patients (prone to cramps or restless legs) and healthy volunteers
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)
Change from baseline estimates of persistent inward current 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)
comparison of estimates of persistent inward current strength in plantar flexor muscles between patients (prone to cramps or restless legs) and healthy volunteers

Secondary Outcome Measures

Change in voluntary activation level and contractile properties of the plantar flexor muscles
Change from baseline voluntary activation level and contractile properties of the plantar flexor muscles after the six-week training period in stroke patients
voluntary activation level and contractile properties of the plantar flexor muscles
comparison of voluntary activation level and contractile properties of the plantar flexor muscles between patients (prone to cramps or restless legs) and healthy volunteers
change in spasticity at the ankle joint level for stroke patients
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
10-m walking test (s)
functional test
6-min walking test (m)
functional test
time up and go test (s)
functional test
Change in spinal excitability in stroke patients
change from baseline soleus Hoffmann reflex amplitude after the six-week training period in stroke patients
Spinal excitability
comparison of soleus Hoffmann reflex amplitude between patients (prone to cramps or restless legs) and healthy volunteers
Cramp threshold frequency (CTF) for cramp-prone individuals
comparison between participants reporting muscle cramps and healthy volunteers

Full Information

First Posted
May 16, 2023
Last Updated
June 8, 2023
Sponsor
University of Lausanne
Collaborators
Swiss National Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05908214
Brief Title
The Application of Wide Pulse High Frequency Neuromuscular Electrical Stimulation in Disorders Associated With Motoneuron Hyperexcitability
Acronym
MnHyperex
Official Title
The Application of Wide Pulse High Frequency Neuromuscular Electrical Stimulation in Disorders Associated With Motoneuron Hyperexcitability
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 12, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne
Collaborators
Swiss National Science Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cramp, Restless Legs Syndrome, Healthy Volunteers
Keywords
muscle strength, persistent inward current, training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Stroke patients in the training group will be compared to stroke patients in the control group. Participants prone to cramps will be compared to healthy participants. Patients with restless legs syndrome will be compared to healthy participants.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stroke patients - training group
Arm Type
Experimental
Arm Description
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.
Arm Title
stroke patients - control group
Arm Type
No Intervention
Arm Description
Participants in this group will keep their daily life activities for 6 weeks and plantar flexor neuromuscular function will be assessed before and after training.
Intervention Type
Other
Intervention Name(s)
wide pulse high frequency neuromuscular electrical stimulation training
Intervention Description
Plantar flexors will be stimulated with wide pulse high frequency neuromuscular electrical stimulation 3 times a week for 6 weeks
Primary Outcome Measure Information:
Title
Change in maximal voluntary contraction force
Description
Change from baseline maximal voluntary contraction force after the six-week training period in stroke patients
Time Frame
through study completion, an average of 8 weeks
Title
Change in NMES-evoked force
Description
Change from baseline NMES-evoked force after the six-week training period
Time Frame
through study completion, an average of 8 weeks
Title
NMES-evoked force
Description
Comparison of NMES-evoked force in plantar flexor muscles between patients (prone to cramps or restless legs) and healthy volunteers
Time Frame
through study completion, an average of 2 weeks
Title
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)
Description
Change from baseline estimates of persistent inward current after the six-week training period in stroke patients
Time Frame
through study completion, an average of 8 weeks
Title
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)
Description
comparison of estimates of persistent inward current strength in plantar flexor muscles between patients (prone to cramps or restless legs) and healthy volunteers
Time Frame
through study completion, an average of 8 weeks
Secondary Outcome Measure Information:
Title
Change in voluntary activation level and contractile properties of the plantar flexor muscles
Description
Change from baseline voluntary activation level and contractile properties of the plantar flexor muscles after the six-week training period in stroke patients
Time Frame
through study completion, an average of 8 weeks
Title
voluntary activation level and contractile properties of the plantar flexor muscles
Description
comparison of voluntary activation level and contractile properties of the plantar flexor muscles between patients (prone to cramps or restless legs) and healthy volunteers
Time Frame
through study completion, an average of 2 weeks
Title
change in spasticity at the ankle joint level for stroke patients
Description
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
Time Frame
through study completion, an average of 8 weeks
Title
10-m walking test (s)
Description
functional test
Time Frame
through study completion, an average of 8 weeks
Title
6-min walking test (m)
Description
functional test
Time Frame
through study completion, an average of 8 weeks
Title
time up and go test (s)
Description
functional test
Time Frame
through study completion, an average of 8 weeks
Title
Change in spinal excitability in stroke patients
Description
change from baseline soleus Hoffmann reflex amplitude after the six-week training period in stroke patients
Time Frame
through study completion, an average of 8 weeks
Title
Spinal excitability
Description
comparison of soleus Hoffmann reflex amplitude between patients (prone to cramps or restless legs) and healthy volunteers
Time Frame
through study completion, an average of 2 weeks
Title
Cramp threshold frequency (CTF) for cramp-prone individuals
Description
comparison between participants reporting muscle cramps and healthy volunteers
Time Frame
through study completion, an average of 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: The presence of periodic limb movements A dopaminergic treatment response The presence of RLS in first-degree relatives 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Place, PhD
Phone
+41216923806
Email
nicolas.place@unil.ch
Facility Information:
Facility Name
Bâtiment Synathlon, quartier UNIL-Centre
City
Lausanne
ZIP/Postal Code
1015
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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