Healthy SubjectsNCT04884698
"Electromagnetical Stimulation of Phrenic Nerve to Generate Contraction of the Diaphragm"
A study testing Stimit Activator in people with Healthy Subjects and Elective Surgical Procedure, run by Stimit AG at 1 site in Switzerland.
Trial summary
The scientific study is intended to show that external non-invasive electromagnetic stimulation can be used to safely and effectively stimulate the phrenic nerve in awake healthy subjects as well as in ventilated, anesthetized patients and that the stimulation can generate a diaphragmatic contraction that generates… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Elective Surgical Procedure
- What is being tested?
- Stimit Activator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Jun 2021to 13 Dec 2021
- 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
- Persons aged > 18 years
- Applicable for Group 2: planned for elective surgery
- No relevant pre-existing conditions - corresponding to American Society of Anesthesiologists (ASA) level of I-II.
- Written informed consent by the patient for participation in the study given
Who cannot join
- chronic lung diseases (bronchial asthma, COPD)
- known diaphragmatic weakness
- known neurological conditions with motor muscle weakness
- known paralysis of the phrenic nerve
- conditions that limit the mobility of the diaphragm (high intra-abdominal pressure, ascites, BMI >30)
- not able to read and understand the national language German
Show all 14Show fewer
- skin lesions, infections or strictures in the neck area
- persons with Implanted cardiac support systems (pacemaker, implanted defibrillator)
- persons with implanted medical pumps
- pregnant women
- persons deprived of liberty by administrative or judicial decision or under legal guardianship.
- Participation in another clinical trial
- Applicable for group 2 (intubated and mechanically ventilated) patients: Exclusion criteria at the time of stimulation:
- Unstable patient after induction of anesthesia and intubation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Electromagnetical Stimulation of the Phrenic Nerve to Generate Contraction of the Diaphragm in Healthy Subjects and Anaesthetized and Intubated Patients - a Feasibility Study"
The scientific study is intended to show that external non-invasive electromagnetic stimulation can be used to safely and effectively stimulate the phrenic nerve in awake healthy subjects as well as in ventilated, anesthetized patients and that the stimulation can generate a diaphragmatic contraction that generates significant breath volume - a Controlled Own Breath (COB).
Also of interest is the reproducibility of the generated diaphragmatic movements and the reliability of different feedback signals for detecting the generated diaphragmatic contraction. This applies to inspiration and expiration detection for subsequent synchronization mechanisms of the magnetic stimulator for patient-initiated breathing as well as to contraction intensity. Further, the characterization of the position finding process is of great importance, so that technical developments can further simplify the process of coil positioning in the future. The possible occurrence of discomfort and pain sensation will also be investigated in awake healthy volunteers. Different stimulation protocols will be used.
Finally, it will be investigated whether an adjusted coil position still triggers reproducible diaphragmatic contractions after removal and repositioning in the same configuration. The knowledge gained will be used to further develop the technique and to prepare a study in critically ill, ventilated patients where the diaphragmatic muscle is to be treated preventively by stimulating the phrenic nerve, in order to prevent atrophy of the muscle.
- Conditions
- Healthy Subjects, Elective Surgical Procedure
- Being tested
- Stimit Activator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimit ActivatorDevice
The Stimit Activator Device is composed of three components.
- A magnetic stimulator generating current pulses
- A novel Stimit coil design optimized for phrenic nerve stimulation
- A coil positioning device for quick, easy and reproducible coil positioning
| Study group | Role | What they receive |
|---|---|---|
| Phrenic nerve stimulation with Stimit Activator | Experimental | Not described Receives: Device: Stimit Activator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in airway pressure / endpoint Group 1:
The primary outcome / endpoint is the change in airway pressure at the mouth during stimulation as seen with or without the use of the ventilator
Measured: During stimulation
Discomfort / pain during stimulation measured by Visual Analogue Scale / endpoint Group 1:
The primary outcome / endpoint is the level of discomfort / pain during stimulation, measured by Visual Analogue Scale(0-100, with 100 being worst pain / discomfort)
Measured: During stimulation
Change in airway pressure / endpoint Group 2:
The primary outcome / endpoint is the change in airway pressure during stimulation as seen with or without the use of the ventilator during stimulation.
Measured: During stimulation
Secondary outcomes (9)
Diaphragmatic contraction
Diaphragmatic contraction at 20 percent / 30 percent / 40 percent stimulation intensity at the optimal stimulation site, at 25 Hz and 2s stimulation time
Measured: During stimulation
Feedback signals
Change of the maximum value of the feedback signals in percent of the maximum depending on the coil position (in 0.5 cm steps; at least 3 steps in each direction)
Measured: During stimulation
Time stimulation start to end
Time (mean value \& standard deviation) between stimulation start and stimulation end (trigger signal start and end) until the feedback signals from:
- the abdominal belt,
- the Diaphragm Thickening Fraction ((TFdi) according to standard procedure, measured via ultrasound during stimulation), and
- the Diaphragm Excursion Signal "respons" (measured by ultrasound during stimulation)
Measured: During stimulation
Correlation stimulation intensity and diaphragm contraction
Correlation between stimulation intensity (power output in percent) and diaphragm contraction, measured by tidal volume, at the optimal coil position at given frequency (25 Hz) and given stimulation duration
Measured: During stimulation
Optimal stimulation site - distance
Distance from anatomical landmark (a) to optimal stimulation site (b) and phrenic nerve (c) using ultrasound and between b and c
Measured: During stimulation
Optimal stimulation site - time
Time from the start of coil positioning to finding a coil positioning which produces the maximum diaphragmatic contraction at a given stimulation intensity and frequency of 25 Hz
Measured: During stimulation
Tidal volumes
The mean and standard deviation of generated tidal volumes for ten stimulations performed without the subject being ventilated
Measured: During stimulation
Skin reactions / musle activation
For Group 1: evaluation of stimulation-induced local skin reactions or muscle activation leading to paresthesia in the dental area
Measured: During stimulation
Safety outcome
The safety outcome/ endpoint is the occurrence of the following events during stimulation:
- Device related Adverse Events
- Device related Serious Adverse Events
Measured: During stimulation and postoperatively, usually within 2-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start25 Jun 2021
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Open-label, sponsor-initiated feasibility study. 2 groups of patients treated - healthy subjects and elective surgery patient
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stimit AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Baumberger, MD, Principal investigator, Swiss Paraplegic Center Nottwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884698
- Sponsor's protocol ID
- Stimit swiss I
- Status last verified
- Jun 2021
- First submitted
- 30 Apr 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Electromagnetical Stimulation of the Phrenic Nerve to Generate Contraction of the Diaphragm in Healthy Subjects and Anaesthetized and Intubated Patients - a Feasibility Study"
- ClinicalTrials.gov ID
- NCT04884698
- Acronym / sponsor ID
- Stimit swiss I
- Conditions
- Healthy Subjects, Elective Surgical Procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Stimit AGIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 13 May 2021 (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 scientific study is intended to show that external non-invasive electromagnetic stimulation can be used to safely and effectively stimulate the phrenic nerve in awake healthy subjects as well as in ventilated, anesthetized patients and that the stimulation can generate a diaphragmatic contraction that generates significant breath volume - a Controlled Own Breath (COB).
Also of interest is the reproducibility of the generated diaphragmatic movements and the reliability of different feedback signals for detecting the generated diaphragmatic contraction. This applies to inspiration and expiration detection for subsequent synchronization mechanisms of the magnetic stimulator for patient-initiated breathing as well as to contraction intensity. Further, the characterization of the position finding process is of great importance, so that technical developments can further simplify the process of coil positioning in the future. The possible occurrence of discomfort and pain sensation will also be investigated in awake healthy volunteers. Different stimulation protocols will be used.
Finally, it will be investigated whether an adjusted coil position still triggers reproducible diaphragmatic contractions after removal and repositioning in the same configuration. The knowledge gained will be used to further develop the technique and to prepare a study in critically ill, ventilated patients where the diaphragmatic muscle is to be treated preventively by stimulating the phrenic nerve, in order to prevent atrophy of the muscle.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, sponsor-initiated feasibility study. 2 groups of patients treated - healthy subjects and elective surgery patient
| Arm | Type | Receives |
|---|---|---|
| Phrenic nerve stimulation with Stimit Activator | Experimental | Device: Stimit Activator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Persons aged > 18 years
- Applicable for Group 2: planned for elective surgery
- No relevant pre-existing conditions - corresponding to American Society of Anesthesiologists (ASA) level of I-II.
- Written informed consent by the patient for participation in the study given
Key exclusion criteria (14 listed)
- chronic lung diseases (bronchial asthma, COPD)
- known diaphragmatic weakness
- known neurological conditions with motor muscle weakness
- known paralysis of the phrenic nerve
- conditions that limit the mobility of the diaphragm (high intra-abdominal pressure, ascites, BMI >30)
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 |
|---|---|---|
| Stimit ActivatorThe Stimit Activator Device is composed of three components. 1. A magnetic stimulator generating current pulses 2. A novel Stimit coil design optimized for phrenic nerve stimulation 3. A coil positioning device for quick, easy and reproducible coil positioning | Device | Phrenic nerve stimulation with Stimit Activator |
Primary outcome
Change in airway pressure / endpoint Group 1:
Time frame: During stimulation
The primary outcome / endpoint is the change in airway pressure at the mouth during stimulation as seen with or without the use of the ventilator
Discomfort / pain during stimulation measured by Visual Analogue Scale / endpoint Group 1:
Time frame: During stimulation
The primary outcome / endpoint is the level of discomfort / pain during stimulation, measured by Visual Analogue Scale(0-100, with 100 being worst pain / discomfort)
Change in airway pressure / endpoint Group 2:
Time frame: During stimulation
The primary outcome / endpoint is the change in airway pressure during stimulation as seen with or without the use of the ventilator during stimulation.
9 secondary outcomes
Diaphragmatic contraction
Time frame: During stimulation
Feedback signals
Time frame: During stimulation
Time stimulation start to end
Time frame: During stimulation
Correlation stimulation intensity and diaphragm contraction
Time frame: During stimulation
Optimal stimulation site - distance
Time frame: During stimulation
Optimal stimulation site - time
Time frame: During stimulation
Tidal volumes
Time frame: During stimulation
Skin reactions / musle activation
Time frame: During stimulation
Safety outcome
Time frame: During stimulation and postoperatively, usually within 2-3 hours
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 6 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Healthy Subjects
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
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.
Michael Baumberger, MD principal investigator
Swiss Paraplegic Center Nottwil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimit Activator in people with Healthy Subjects and Elective Surgical Procedure, run by Stimit AG 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 4 inclusion and 14 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 6 Jan 2022. 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?
Change in airway pressure / endpoint Group 1: (time frame: During stimulation). The study lists 3 primary outcomes in all. 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 6 Jan 2022.