HealthyNCT04176744
Optimization of Non-invasive Diaphragm Activation Using Magnetic Phrenic Nerve Stimulation
A study testing Uni- and bilateral magnetic phrenic nerve stimulation in people with Healthy, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
The use of mechanical ventilation (MV) to replace spontaneous breathing has been associated with respiratory muscle dysfunction and lung injury from positive pressure. While using MV in an intensive care unit setting, the diaphragm is unloaded, potentially resulting in early development of diaphragmatic atrophy in as… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Uni- and bilateral magnetic phrenic nerve stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Dec 2019to 15 Jul 2020
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed Consent as documented by signature
- Age: 18 - 35 years
- Non-smoking
- Healthy
- Able to communicate in English
- Normal lung function
- Normal Body mass index between 18.5 and 24.9 kg/m2
- Willingness to adhere to the study rules
Who cannot join
- Acute illness or chronic conditions affecting sleep or the performance of the respiratory, cardiovascular, neuromuscular, gastrointestinal or muscle system
- Women who are pregnant or breast feeding or have the intention to become pregnant during the course of the study
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Known or suspected non-compliance, drug or alcohol abuse
- Intake of medication affecting sleep or the performance of the respiratory, cardiovascular or neuromuscular system or gastrointestinal or muscle system
- Presence of cardiac pacemaker, implanted defibrillators or implanted neurostimulators
Show all 10Show fewer
- Any metal or electronics inside of the body
- History of seizures or epilepsy
- Tattoos on the stimulation sites
- Previous enrolment into the current study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
Zurich, Canton of Zurich, 8057
About this study
The use of mechanical ventilation (MV) to replace spontaneous breathing has been associated with respiratory muscle dysfunction and lung injury from positive pressure. While using MV in an intensive care unit setting, the diaphragm is unloaded, potentially resulting in early development of diaphragmatic atrophy in as early as 18 hours of complete diaphragm inactivity. These changes in muscle properties result in a decrease in the force generating capability of the muscle, ultimately resulting in difficulty to restore spontaneous breathing and a subsequent prolonged weaning process or failure. A prolonged weaning period is associated with longer duration of MV, which may result in a cascade of further diaphragm dysfunction, weakness, and injury.
Stimulation of the phrenic nerves to produce diaphragm contraction and activity is a possible mechanism to reduce MV related diaphragm dysfunction. Two promising studies have shown the potential of repetitive phrenic nerve stimulation on inducing diaphragm activity in human subjects with trains of pulses via both cervical and bilateral phrenic nerve stimulation. However, neither study provided optimal stimulation settings. As such, the primary purpose of this study is to investigate the optimal settings for noninvasive phrenic nerve stimulation to induce diaphragm contraction.
- Conditions
- Healthy
- Being tested
- Uni- and bilateral magnetic phrenic nerve stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uni- and bilateral magnetic phrenic nerve stimulationOther
Uni- and bilateral magnetic phrenic nerve stimulation using different coils, stimulation patterns (frequency, intensity, number of pulses) and locations (neck, chest).
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Phrenic Nerve Stimulation | Experimental | Each participant will be tested with 4 different stimulation setups (coils and stimulator) on 3 different days. Receives: Other: Uni- and bilateral magnetic phrenic nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in airflow
Flow will be recorded by a pneumotachometer and averaged over breaths.
Measured: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Changes in costal diaphragm activity
Costal diaphragm activity will be continuously recorded via a wireless surface electromyography system.
Measured: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Changes in transdiaphragmatic pressure
Transdiaphragmatic pressure changes, i.e. changes in esophageal and gastric pressures, will be measured by a pressure transducer connected to balloon-catheters.
Measured: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Changes in mouth pressure
Mouth pressure will be continuously recorded using a differential pressure transducer.
Measured: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Changes in abdominal movements
Abdominal movements will be assessed using the respiratory belt strain transducer.
Measured: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Secondary outcomes (4)
Changes in extradiaphragmatic muscle activity
Muscle activity will be continuously recorded via a wireless surface electromyography system.
Measured: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Changes in head, shoulder and arm movements
Head, shoulder and arm movements will be recorded using wireless acceleration sensors.
Measured: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Changes in stress related parameters (heart rate, blood pressure, skin conductance)
Heart rate will will be continuously recorded with electrodes. Blood pressure will be continuously recorded using a non-invasive device. Skin conductance will be continuously recorded with electrodes worn on two fingers.
Measured: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Perception of pain, paresthesia and distress
Participant subject perception of pain, paresthesia and distress will be evaluated with a visual analogue scales.
Measured: Assessed 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start9 Dec 2019
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant enrolled in the study will be tested with different stimulation settings on three different days in a randomized order.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina M. Spengler, Prof., Principal investigator, Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176744
- Sponsor's protocol ID
- OPTISTIM_2019
- Status last verified
- Dec 2019
- First submitted
- 19 Nov 2019
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boyle KGPJM, Eichenberger PA, Schon P, Spengler CM. Inspiratory response and side-effects to rapid bilateral magnetic phrenic nerve stimulation using differently shaped coils: implications for stimulation-assisted mechanical ventilation. Respir Res. 2022 Dec 17;23(1):357. doi: 10.1186/s12931-022-02251-y.
PubMed 36528761
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Non-invasive Diaphragm Activation Using Magnetic Phrenic Nerve Stimulation
- ClinicalTrials.gov ID
- NCT04176744
- Acronym / sponsor ID
- OPTISTIM_2019
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 25 Nov 2019 (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.
The use of mechanical ventilation (MV) to replace spontaneous breathing has been associated with respiratory muscle dysfunction and lung injury from positive pressure. While using MV in an intensive care unit setting, the diaphragm is unloaded, potentially resulting in early development of diaphragmatic atrophy in as early as 18 hours of complete diaphragm inactivity. These changes in muscle properties result in a decrease in the force generating capability of the muscle, ultimately resulting in difficulty to restore spontaneous breathing and a subsequent prolonged weaning process or failure. A prolonged weaning period is associated with longer duration of MV, which may result in a cascade of further diaphragm dysfunction, weakness, and injury.
Stimulation of the phrenic nerves to produce diaphragm contraction and activity is a possible mechanism to reduce MV related diaphragm dysfunction. Two promising studies have shown the potential of repetitive phrenic nerve stimulation on inducing diaphragm activity in human subjects with trains of pulses via both cervical and bilateral phrenic nerve stimulation. However, neither study provided optimal stimulation settings. As such, the primary purpose of this study is to investigate the optimal settings for noninvasive phrenic nerve stimulation to induce diaphragm contraction.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant enrolled in the study will be tested with different stimulation settings on three different days in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| Magnetic Phrenic Nerve Stimulation | Experimental | Other: Uni- and bilateral magnetic phrenic nerve stimulationEach participant will be tested with 4 different stimulation setups (coils and stimulator) on 3 different days. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Informed Consent as documented by signature
- Age: 18 - 35 years
- Non-smoking
- Healthy
- Able to communicate in English
Key exclusion criteria (10 listed)
- Acute illness or chronic conditions affecting sleep or the performance of the respiratory, cardiovascular, neuromuscular, gastrointestinal or muscle system
- Women who are pregnant or breast feeding or have the intention to become pregnant during the course of the study
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Known or suspected non-compliance, drug or alcohol abuse
- Intake of medication affecting sleep or the performance of the respiratory, cardiovascular or neuromuscular system or gastrointestinal or muscle system
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 |
|---|---|---|
| Uni- and bilateral magnetic phrenic nerve stimulationUni- and bilateral magnetic phrenic nerve stimulation using different coils, stimulation patterns (frequency, intensity, number of pulses) and locations (neck, chest). | Other | Magnetic Phrenic Nerve Stimulation |
Primary outcome
Changes in airflow
Time frame: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Flow will be recorded by a pneumotachometer and averaged over breaths.
Changes in costal diaphragm activity
Time frame: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Costal diaphragm activity will be continuously recorded via a wireless surface electromyography system.
Changes in transdiaphragmatic pressure
Time frame: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Transdiaphragmatic pressure changes, i.e. changes in esophageal and gastric pressures, will be measured by a pressure transducer connected to balloon-catheters.
Changes in mouth pressure
Time frame: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Mouth pressure will be continuously recorded using a differential pressure transducer.
Changes in abdominal movements
Time frame: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Abdominal movements will be assessed using the respiratory belt strain transducer.
4 secondary outcomes
Changes in extradiaphragmatic muscle activity
Time frame: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Changes in head, shoulder and arm movements
Time frame: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Changes in stress related parameters (heart rate, blood pressure, skin conductance)
Time frame: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Perception of pain, paresthesia and distress
Time frame: Assessed 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Derived from this study: PubMed 36528761Boyle KGPJM, Eichenberger PA, Schon P, Spengler CM. Inspiratory response and side-effects to rapid bilateral magnetic phrenic nerve stimulation using differently shaped coils: implications for stimulation-assisted mechanical ventilation. Respir Res. 2022 Dec 17;23(1):357. doi: 10.1186/s12931-022-02251-y.
- Individual participant dataSharing planned: No
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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.
Christina M. Spengler, Prof. principal investigator
Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uni- and bilateral magnetic phrenic nerve stimulation in people with Healthy, run by Swiss Federal Institute of Technology 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 8 inclusion and 10 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: finished, as of the sponsor's last update on 12 Aug 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in airflow (time frame: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04176744, which also lists 1 linked publication.
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 12 Aug 2020.