Neuron Disease, MotorNCT06584084
Technical and Clinical Validation of the WPM-SEMG Prototype
A study testing WPM-SEMG prototype in people with Neuron Disease, Motor, run by Alain Kaelin at 1 site in Switzerland.
Trial summary
Validation study designed to demonstrate the technical and clinical performance, and the safety of a new medical device in healthy volunteers and patients with myopathy or neuropathy. The medical device is the WPM-SEMG prototype designed for recording electrophysiological signals of muscles. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuron Disease, Motor
- What is being tested?
- WPM-SEMG prototype
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Jan 2018to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Female or male
- 18 years or older
- Preserved cognitive capacity
- Ability to understand the study
- Willingness to complete all the study assessments
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- No chronic or concomitant use of medications or treatment
- Written informed consent
- Patients of the Neurocentro della Svizzera Italiana with diagnosis of myopathy or neuropathy that requires a needle-EMG electrophysiological testing as standard clinical management of the disease
- Female or male
- 18 years or older
- Preserved cognitive capacity
- Ability to understand the study
- Willingness to complete all the study assessments
- No chronic or concomitant use of medications or treatment that may influence the measure in the opinion of the investigator (muscle relaxant such as baclofen, statin, benzodiazepine).
- Written informed consent
Who cannot join
- Skin lesions in the area below the electrode
- Allergy to metal alloys
- History of skin disease
- Pregnancy
- Lactation
- Known causes of neuromuscular disease
Show all 16Show fewer
- Inability to follow the procedures of the study
- Eligibility criteria for patients
- Skin lesions in the area below the electrode
- Allergy to metal alloys
- History of skin disease
- Cognitive and/or psychiatric disorders
- Pregnancy
- Lactation
- Neuromuscular disease other than myopathy and neuropathy
- Inability to follow the procedures of the study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Neurocentro della Svizzera Italiana
Lugano, 6900
Alain Kaelin, Prof, +41 (0)91 811 62 57, alain.kaelin@eoc.ch
Claudio Gobbi, MD, +41 (0)91 811 69 21, claudio.gobbi@eoc.ch
About this study
Official title: Technical and Clinical Validation Study of a New Wireless Portable and Multi-Channel Surface EMG Device to Analyse Motor Unit Action Potentials
Validation study designed to demonstrate the technical and clinical performance, and the safety of a new medical device in healthy volunteers and patients with myopathy or neuropathy. The medical device is the WPM-SEMG prototype designed for recording electrophysiological signals of muscles.
Read the detailed description
The study consists of two parts:
- the first part concerns the technical validation of the prototype. It will enrol 10 healthy volunteers (Technical Validation Group).
- the second part concerns the clinical validation of the prototype in comparison with the gold standard, that is the needle-EMG. It will enrol 50 healthy volunteers (Clinical Validation Group), including also the 10 subjects of the Technical Validation Group, and 20 patients
Measurements will be done on 4 muscles with the WPM-SEMG device prototype using a rigid electrode matrix. For each muscle, the participant will execute some spontaneous motor activities and measurements will be taken on the muscle under tension (low, medium, and high) for a total of 12 measurements. Measurements will be repeated two times after a pause for a total of 24 acquisitions. For the group with myopathies an additional fifth muscle, not foreseen by the protocol, can be done if considered the clinical most affected muscle followingthe neurological examination.
A control intervention is done on the same subjects and consists in a needle-EMG which will be applied as for routine clinical practice on the same muscles used for the WPM-SEMG device prototype. Measurements will be taken for each muscles as for the rigid matrix.
- Conditions
- Neuron Disease, Motor
- Being tested
- WPM-SEMG prototype
- Medical subject headings
- Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WPM-SEMG prototypeDevice
Measurements will be done with the rigid matrix. The flexible electrode matrix will be used only on a lower percentage of volunteers depending on the results obtained with the rigid matrix
| Study group | Role | What they receive |
|---|---|---|
| Muscle electrophysiological signals recording | Experimental | Recording of electrophysiological signals of muscles with a WPM-SEMG prototype Receives: Device: WPM-SEMG prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical and clinical assessment
Correlation between the properties of the final electrophysiological output identified from sEMG signals acquired with the WPM-SEMG device prototype and the properties of the final electrophysiological output identified from EMG signals acquired using needle EMG. [Time Frame: Intervention (day0)]
The following properties will be extracted: Amplitude (microVolts), phases/turns (ratio), signal frequency (Hz) and duration (seconds).
Measured: Intervention (day0)
Secondary outcomes (1)
Pain assessment
Pain assessment during the measurements using the Visual Analog Scale (VAS). The VAS consists on a 0-10 scale, with two end points representing 0 ('no pain') and 10 ('worst possible pain').
Measured: Intervention (day0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start19 Jan 2018
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuron Disease, MotorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant will undergo to the study intervention and the control intervention
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alain Kaelin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Applied Sciences and Arts of Southern Switzerland, Clinical Trial Unit Ente Ospedaliero Cantonale
- Responsible party
- Sponsor-investigator, Alain Kaelin, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584084
- Sponsor's protocol ID
- SUPSI-2017-006
- Status last verified
- Sep 2024
- First submitted
- 23 Jan 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical and Clinical Validation Study of a New Wireless Portable and Multi-Channel Surface EMG Device to Analyse Motor Unit Action Potentials
- ClinicalTrials.gov ID
- NCT06584084
- Acronym / sponsor ID
- SUPSI-2017-006
- Conditions
- Neuron Disease, Motor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Alain KaelinUniversity, hospital or other
- Collaborators
- University of Applied Sciences and Arts of Southern Switzerland, Clinical Trial Unit Ente Ospedaliero Cantonale
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 4 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Validation study designed to demonstrate the technical and clinical performance, and the safety of a new medical device in healthy volunteers and patients with myopathy or neuropathy. The medical device is the WPM-SEMG prototype designed for recording electrophysiological signals of muscles.
Detailed description
The study consists of two parts:
- the first part concerns the technical validation of the prototype. It will enrol 10 healthy volunteers (Technical Validation Group).
- the second part concerns the clinical validation of the prototype in comparison with the gold standard, that is the needle-EMG. It will enrol 50 healthy volunteers (Clinical Validation Group), including also the 10 subjects of the Technical Validation Group, and 20 patients
Measurements will be done on 4 muscles with the WPM-SEMG device prototype using a rigid electrode matrix. For each muscle, the participant will execute some spontaneous motor activities and measurements will be taken on the muscle under tension (low, medium, and high) for a total of 12 measurements. Measurements will be repeated two times after a pause for a total of 24 acquisitions. For the group with myopathies an additional fifth muscle, not foreseen by the protocol, can be done if considered the clinical most affected muscle followingthe neurological examination.
A control intervention is done on the same subjects and consists in a needle-EMG which will be applied as for routine clinical practice on the same muscles used for the WPM-SEMG device prototype. Measurements will be taken for each muscles as for the rigid matrix.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant will undergo to the study intervention and the control intervention
| Arm | Type | Receives |
|---|---|---|
| Muscle electrophysiological signals recording | Experimental | Device: WPM-SEMG prototypeRecording of electrophysiological signals of muscles with a WPM-SEMG prototype |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
Key exclusion criteria (16 listed)
- Eligibility criteria for patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WPM-SEMG prototypeMeasurements will be done with the rigid matrix. The flexible electrode matrix will be used only on a lower percentage of volunteers depending on the results obtained with the rigid matrix | Device | Muscle electrophysiological signals recording |
Primary outcome
Technical and clinical assessment
Time frame: Intervention (day0)
Correlation between the properties of the final electrophysiological output identified from sEMG signals acquired with the WPM-SEMG device prototype and the properties of the final electrophysiological output identified from EMG signals acquired using needle EMG. [Time Frame: Intervention (day0)] The following properties will be extracted: Amplitude (microVolts), phases/turns (ratio), signal frequency (Hz) and duration (seconds).
1 secondary outcome
Pain assessment
Time frame: Intervention (day0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WPM-SEMG prototype in people with Neuron Disease, Motor, run by Alain Kaelin at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alain Kaelin, Prof. (+41 (0)91 811 62 57, alain.kaelin@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical and clinical assessment (time frame: Intervention (day0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.