Muscle WeaknessSTIMIT-IINCT05238753
Electromagnetic Stimulation of the Phrenic Nerve in Critically Ill Mechanically Ventilated Patients (STIMIT-II)
A study testing Non-invasive electromagnetic stimulation in people with Muscle Weakness and Critical Illness, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Ventilator-induced diaphragmatic dysfunction is a common issue in critically ill patients. Muscle stimulation has shown to have beneficial effects in muscle groups on the extremities. A non-invasive way to stimulate the diaphragm would be the electromagnetic stimulation but it is currently unclear if that is feasible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Weakness, Critical Illness, Mechanical Ventilation Complication
- What is being tested?
- Non-invasive electromagnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 21 Jan 2022to 15 May 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 and 60 years old, hospitalized in ICU
- Mechanical ventilation < 36 h
- Prone to stay ventilated > 72 h
Who cannot join
- Known neurological condition affecting motor neuron or muscle (e.g. ALS)
- Known paralysis of the phrenic nerve
- Proven or suspected spinal cord injury that contraindicates weight bearing on the spinal cord
- Conditions that limit diaphragm movement (high intra-abdominal pressure, ascites, obesity)
- Not able to read and understand the national language German
- Patients with Implanted cardiac support systems (pacemaker, implanted defibrillator)
Show all 10Show fewer
- Patients with implanted medical pumps
- Pregnant patients
- Patients with skin lesions, infections or strictures in throat/neck area
- Patients with metallic implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electromagnetic Stimulation of the Phrenic Nerve to Generate Contraction of the Diaphragm in Critically Ill Mechanically Ventilated Patients - a Proof-of-concept Study (STIMIT-II)
Ventilator-induced diaphragmatic dysfunction is a common issue in critically ill patients. Muscle stimulation has shown to have beneficial effects in muscle groups on the extremities. A non-invasive way to stimulate the diaphragm would be the electromagnetic stimulation but it is currently unclear if that is feasible.
In this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction in critically ill ICU patients via an external electromagnetic stimulation of the phrenic nerve, leading to an inspiration (i) with a sufficient tidal volume (3-6 ml/kg ideal body weight) and (ii) with verifiable muscular diaphragmatic contraction through ultrasound imaging.
Read the detailed description
During the time of first spontaneous breathing trial 60% of mechanically ventilated patients present with diaphragmatic weakness or also know as ventilator-induced diaphragmatic dysfunction (VIDD). The damage to the diaphragm in terms of muscle atrophy has been shown as early as 12 hours after initiation of mechanical ventilation. Recently, a correlation between diaphragmatic atrophy and mortality could be established.
Induction of diaphragmatic contractions via stimulation of the phrenic nerve would be a possible method to prevent or treat VIDD. A possible modality would be the non-invasive electromagnetic stimulation but feasibility has not been established.
In this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction in critically ill ICU patients via an external electromagnetic stimulation of the phrenic nerve, leading to an inspiration (i) with a sufficient tidal volume (3-6 ml/kg ideal body weight) and (ii) with verifiable muscular diaphragmatic contraction through ultrasound imaging.
- Being tested
- Non-invasive electromagnetic stimulation
- Keywords
- VIDD, ICUAW, Muscle Weakness, Weaning
- Medical subject headings
- Muscle Weakness, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive electromagnetic stimulationDevice
Non-invasive bilateral electromagnetic stimulation of the phrenic nerve
| Study group | Role | What they receive |
|---|---|---|
| Intervention, stimulated | Experimental | Electromagnetic stimulation of the phrenic nerve in critically ill patients. Receives: Device: Non-invasive electromagnetic stimulation |
| Control, not stimulated | No intervention | Control group, no stimulation of the phrenic nerve. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of non-feasible stimulation, due to organisational or patient-specific reasons.
Percentage of non-feasible stimulation out of the total number of stimulations planned according to the investigation protocol.
Measured: 10 days
Time to find the optimal stimulation point of the N. phrenicus
Time between first successful N. phrenicus stimulation and identification of the optimal stimulation locus in seconds
Measured: Study duration (10 days)
Frequency of sufficient Tidal volume generated by electromagentical stimulation of the phrenic nerve (3-6 ml/kg ideal body weight)
Percentage of stimulated breaths above the cut-off Today volume (3-6 ml/kg ideal body weigh) out of the total number of stimulated breaths. Tidal volumes are measured by the mechanical ventilator.
Measured: Study duration (10 days)
Secondary outcomes (12)
Variance of Tidal volume generated by electromagentical stimulation of the phrenic nerve
Measurement of variance among the Tidal volumes stimulated during the experimental therapy intervention; Tidal volumes are measured by the mechanical ventilator.
Measured: Study duration (10 days)
Correlation between amplitude and duration of sEMG signals during stimulated breathing.
sEMG amplitude and duration are measured by a device (sEMG Amplificator) connected to electrodes applied to the patient's chest during electromagnetic phrenic nerve stimulation.
Measured: Study duration (10 days)
Transpulmonary pressure during electromagnetical stimulation of the phrenic nerve
Transpulmonary pressure is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation.
Measured: Study duration (10 days)
Occlusion pressure during electromagnetical stimulation of the phrenic nerve
Occlusion pressure is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation.
Measured: Study duration (10 days)
Diaphragm thickening fraction
Diaphragm thickening fraction measured with ultrasound of the diaphragm.
Measured: approx. 28 days (till ICU discharge)
Diaphragm excursion
Diaphragm excursion measured with ultrasound of the diaphragm.
Measured: approx. 28 days (till ICU discharge)
Stimulated tracheal pressure during electromagentical stimulation of the phrenic nerve
Stimulated tracheal pressure is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation.
Measured: Study duration (10 days)
Rapid Shallow Breathing Index (RSBI) record and evaluation.
Progression of RSBI during 10 days after subject inclusion, based on the mechanical ventilation parameters (Tidal volume) and the ICU continuous monitoring system (Respiratory Rate).
Measured: Study duration (10 days)
Lung compliance during electromagentical stimulation of the phrenic nerve
Lung compliance is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation.
Measured: 10 days
Lung resistance during electromagentical stimulation of the phrenic nerve
Lung resistance is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation.
Measured: 10 days
Maximal inspiratory pressure (MIP) during electromagnetical stimulation of the phrenic nerve.
MIP is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation.
Measured: Study duration (10 days)
Expiratory and Inspiratory Diaphragm Thickness measured by Ultrasound
Diaphragm Thickness measured by Ultrasound as a baseline parameter for muscle atrophy.
Measured: Study duration (10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start21 Jan 2022
- Primary completion15 May 2022
- Study completion15 May 2022
Why it stopped: CE certificate ended and was not renewed
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 Muscle WeaknessStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 15 patients in control group, 15 patients in interventional group with sequential design in term of daily frequency of non-invasive electromagnetic phrenic nerve stimulation, i.e. starting with 5 patients with 2 stimulation per day, followed by 5 patients with 3 stimulations and 5 patients with 5 stimulations per day
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Stimit AG
- Responsible party
- Principal investigator, Stefan J Schaller, Charite University, Berlin, Germany
- Investigators
- Stefan J Schaller, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238753
- Sponsor's protocol ID
- STIMIT-II
- Acronym
- STIMIT-II
- Status last verified
- Sep 2022
- First submitted
- 3 Feb 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data can be requested on reasonable scientific request.
Publications
Panelli A, Grimm AM, Krause S, Verfuss MA, Ulm B, Grunow JJ, Bartels HG, Carbon NM, Niederhauser T, Weber-Carstens S, Brochard L, Schaller SJ. Noninvasive Electromagnetic Phrenic Nerve Stimulation in Critically Ill Patients: A Feasibility Study. Chest. 2024 Sep;166(3):502-510. doi: 10.1016/j.chest.2024.02.035. Epub 2024 Feb 24.
PubMed 38403186
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromagnetic Stimulation of the Phrenic Nerve to Generate Contraction of the Diaphragm in Critically Ill Mechanically Ventilated Patients - a Proof-of-concept Study (STIMIT-II)
- ClinicalTrials.gov ID
- NCT05238753
- Acronym / sponsor ID
- STIMIT-II / STIMIT-II
- Keywords
- VIDD, ICUAW, Muscle Weakness, Weaning
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: CE certificate ended and was not renewed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Stimit AG
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 14 Feb 2022 (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.
Ventilator-induced diaphragmatic dysfunction is a common issue in critically ill patients. Muscle stimulation has shown to have beneficial effects in muscle groups on the extremities. A non-invasive way to stimulate the diaphragm would be the electromagnetic stimulation but it is currently unclear if that is feasible.
In this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction in critically ill ICU patients via an external electromagnetic stimulation of the phrenic nerve, leading to an inspiration (i) with a sufficient tidal volume (3-6 ml/kg ideal body weight) and (ii) with verifiable muscular diaphragmatic contraction through ultrasound imaging.
Detailed description
During the time of first spontaneous breathing trial 60% of mechanically ventilated patients present with diaphragmatic weakness or also know as ventilator-induced diaphragmatic dysfunction (VIDD). The damage to the diaphragm in terms of muscle atrophy has been shown as early as 12 hours after initiation of mechanical ventilation. Recently, a correlation between diaphragmatic atrophy and mortality could be established.
Induction of diaphragmatic contractions via stimulation of the phrenic nerve would be a possible method to prevent or treat VIDD. A possible modality would be the non-invasive electromagnetic stimulation but feasibility has not been established.
In this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction in critically ill ICU patients via an external electromagnetic stimulation of the phrenic nerve, leading to an inspiration (i) with a sufficient tidal volume (3-6 ml/kg ideal body weight) and (ii) with verifiable muscular diaphragmatic contraction through ultrasound imaging.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 15 patients in control group, 15 patients in interventional group with sequential design in term of daily frequency of non-invasive electromagnetic phrenic nerve stimulation, i.e. starting with 5 patients with 2 stimulation per day, followed by 5 patients with 3 stimulations and 5 patients with 5 stimulations per day
| Arm | Type | Receives |
|---|---|---|
| Intervention, stimulated | Experimental | Device: Non-invasive electromagnetic stimulationElectromagnetic stimulation of the phrenic nerve in critically ill patients. |
| Control, not stimulated | No intervention | –Control group, no stimulation of the phrenic nerve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between 18 and 60 years old, hospitalized in ICU
- Mechanical ventilation < 36 h
- Prone to stay ventilated > 72 h
Key exclusion criteria (10 listed)
- Known neurological condition affecting motor neuron or muscle (e.g. ALS)
- Known paralysis of the phrenic nerve
- Proven or suspected spinal cord injury that contraindicates weight bearing on the spinal cord
- Conditions that limit diaphragm movement (high intra-abdominal pressure, ascites, obesity)
- Not able to read and understand the national language German
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 |
|---|---|---|
| Non-invasive electromagnetic stimulationNon-invasive bilateral electromagnetic stimulation of the phrenic nerve | Device | Intervention, stimulated |
Primary outcome
Frequency of non-feasible stimulation, due to organisational or patient-specific reasons.
Time frame: 10 days
Percentage of non-feasible stimulation out of the total number of stimulations planned according to the investigation protocol.
Time to find the optimal stimulation point of the N. phrenicus
Time frame: Study duration (10 days)
Time between first successful N. phrenicus stimulation and identification of the optimal stimulation locus in seconds
Frequency of sufficient Tidal volume generated by electromagentical stimulation of the phrenic nerve (3-6 ml/kg ideal body weight)
Time frame: Study duration (10 days)
Percentage of stimulated breaths above the cut-off Today volume (3-6 ml/kg ideal body weigh) out of the total number of stimulated breaths. Tidal volumes are measured by the mechanical ventilator.
12 secondary outcomes
Variance of Tidal volume generated by electromagentical stimulation of the phrenic nerve
Time frame: Study duration (10 days)
Correlation between amplitude and duration of sEMG signals during stimulated breathing.
Time frame: Study duration (10 days)
Transpulmonary pressure during electromagnetical stimulation of the phrenic nerve
Time frame: Study duration (10 days)
Occlusion pressure during electromagnetical stimulation of the phrenic nerve
Time frame: Study duration (10 days)
Diaphragm thickening fraction
Time frame: approx. 28 days (till ICU discharge)
Diaphragm excursion
Time frame: approx. 28 days (till ICU discharge)
Stimulated tracheal pressure during electromagentical stimulation of the phrenic nerve
Time frame: Study duration (10 days)
Rapid Shallow Breathing Index (RSBI) record and evaluation.
Time frame: Study duration (10 days)
Lung compliance during electromagentical stimulation of the phrenic nerve
Time frame: 10 days
Lung resistance during electromagentical stimulation of the phrenic nerve
Time frame: 10 days
Maximal inspiratory pressure (MIP) during electromagnetical stimulation of the phrenic nerve.
Time frame: Study duration (10 days)
Expiratory and Inspiratory Diaphragm Thickness measured by Ultrasound
Time frame: Study duration (10 days)
Results and safety
The study was stopped early (reason given: CE certificate ended and was not renewed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Derived from this study: PubMed 38403186Panelli A, Grimm AM, Krause S, Verfuss MA, Ulm B, Grunow JJ, Bartels HG, Carbon NM, Niederhauser T, Weber-Carstens S, Brochard L, Schaller SJ. Noninvasive Electromagnetic Phrenic Nerve Stimulation in Critically Ill Patients: A Feasibility Study. Chest. 2024 Sep;166(3):502-510. doi: 10.1016/j.chest.2024.02.035. Epub 2024 Feb 24.
- Individual participant dataSharing planned: Yes. Deidentified data can be requested on reasonable scientific request.
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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.
Stefan J Schaller, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive electromagnetic stimulation in people with Muscle Weakness and Critical Illness, run by Charite University, Berlin, Germany at 1 site in Germany.
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 3 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: stopped early, as of the sponsor's last update on 15 Sep 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 Germany. 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 was stopped early (reason given: CE certificate ended and was not renewed). Results are not available in the source record.
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?
Frequency of non-feasible stimulation, due to organisational or patient-specific reasons. (time frame: 10 days). 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?
On the ClinicalTrials.gov record for NCT05238753, 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 15 Sep 2022.