Cerebral InfarctionEDP-VENTNCT07133932
Phrenic Nerve Stimulation for Reducing Ventilation Duration in Acute Cerebral Infarction: A Multicenter Randomized Controlled Trial
A study testing Transcutaneous electrical phrenic nerve stimulation in people with Cerebral Infarction and Mechanical Ventilation, run by Xuanwu Hospital, Beijing at 9 sites in China.
Trial summary
The goal of this clinical trial is to learn if non-invasive phrenic nerve stimulation works in adult acute cerebral infarction participants undergoing mechanical ventilation. It will also learn about the safety of non-invasive phrenic nerve stimulation. The main questions it aims to answer are： 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Infarction, Mechanical Ventilation, Acute Cerebrovascular Accident
- What is being tested?
- Transcutaneous electrical phrenic nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 590 participants
- Where
- 9 sitesChina
- Study dates
- 1 Sep 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- age ≥ 18 years old
- no gender restrictions
- patient diagnosed with acute cerebral infarction (within 30 days of onset) through cranial CT or MRI
- duration of mechanical ventilation ≥ 24 hours
- patient or their legal guardian agrees to participate in the study and signs an informed consent form
Who cannot join
- there are other significant conditions that affect diaphragm function, such as severe malnutrition, irreversible respiratory pump failure caused by medullary or cervical cord injury, and irreversible damage to the phrenic nerve
- significant agitation cannot be combined with transcutaneous electrical phrenic nerve stimulation
- severe skin damage or infection at the electrode placement site
- previous presence of severe lung disease (such as severe COPD, interstitial lung disease, pulmonary embolism, etc.), severe heart failure (NYHA Class IV)
- sepsis or shock requiring high-dose vasopressors
- the terminal state of the disease or expected survival period does not exceed 7 days
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- pacemaker implantation
- pregnant or lactating women
- patients whose family members express their willingness to withdraw for treatment
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Linlin Fan, 86-010-83198899 ext. 8640, windspring7139@163.com
Beijing Ditan Hospital, Capital Medical University
Beijing, 100015
Meijuan Jiang, 86-13811680287, jmj4415@163.com
Beijing Hui Min Hospital
Beijing, 100054
Yanbo He, 86-010-83912719, htyopen@163.com
Sanbo Brain Hospital, Capital Medical University
Beijing, 100093
Zhonghua Shi, 86-010-62856765, z.shi@mail.ccmu.edu.cn
Dongzhimen Hospital Beijing University of Chinese Medicine
Beijing, 100700
Yanen Lv, 86-010-84015028, sjwkl1@sohu.com
Beijing Tongren Hospital, Capital Medical University
Beijing, 100730
Qinglin Yang, 86-010-58266018, lin8082@sina.com
The First Hospital of Fangshan District
Beijing, 102400
Liang Chen, 86-010-69313443-8184, wildexreme@aliyun.com
Beijing Daxing District People's Hospital
Beijing, 102699
Huiliang Yang, 86-010-60283156, yanghuiliang1981@sina.com
The First Hospital of Heibei Medical University
Shijiazhuang, Hebei, 050000
Ya Chang, 86-0311-87156771, 949896097@qq.com
About this study
Official title: Transcutaneous Electrical Phrenic Nerve Stimulation for Reducing Mechanical Ventilation Duration in Acute Cerebral Infarction: A Multicenter Randomized Controlled Trial
The goal of this clinical trial is to learn if non-invasive phrenic nerve stimulation works in adult acute cerebral infarction participants undergoing mechanical ventilation. It will also learn about the safety of non-invasive phrenic nerve stimulation. The main questions it aims to answer are：
- Can non-invasive phrenic nerve stimulation shorten the duration of ventilator use and improve long-term prognosis?
- What medical problems do participants have when taking non-invasive phrenic nerve stimulation? Researchers will compare non-invasive phrenic nerve stimulation to a sham stimulation to see if non-invasive phrenic nerve stimulation works.
Read more
Participants will:
- Receive 14 days of non-invasive phrenic nerve stimulation or sham stimulation
- Visit the clinic or call for follow-up at 90 days of onset
- Being tested
- Transcutaneous electrical phrenic nerve stimulation, Sham (No Treatment)
- Medical subject headings
- Cerebral Infarction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical phrenic nerve stimulationDevice
Non-invasive transcutaneous electrical phrenic nerve stimulation which can cause explicit contraction of the diaphragm, and the stimulation current may be set to 5-30mA depending on the participant's condition.
Sham (No Treatment)Device
The stimulation current is set to 0.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Transcutaneous electrical phrenic nerve stimulation for 14 days Receives: Device: Transcutaneous electrical phrenic nerve stimulation |
| Control group | Sham comparator | Sham stimulation for 14 days Receives: Device: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical ventilation duration
The total duration of mechanical ventilation, which is the time difference between starting mechanical ventilation and successfully weaning.
Measured: Successfully weaned from ventilater for 48 hours
Secondary outcomes (2)
Successful weaning rate
Measured: Successfully weaned from ventilater for 48 hours
mRS at 90 days
Measured: 90 days of symptom onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133932
- Sponsor's protocol ID
- 2025-161-002
- Acronym
- EDP-VENT
- Status last verified
- Aug 2025
- First submitted
- 21 Jul 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the research is completed and the results are published, the project leader can be contacted to obtain the original data.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Phrenic Nerve Stimulation for Reducing Mechanical Ventilation Duration in Acute Cerebral Infarction: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07133932
- Acronym / sponsor ID
- EDP-VENT / 2025-161-002
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Aug 2025 (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 goal of this clinical trial is to learn if non-invasive phrenic nerve stimulation works in adult acute cerebral infarction participants undergoing mechanical ventilation. It will also learn about the safety of non-invasive phrenic nerve stimulation. The main questions it aims to answer are：
- Can non-invasive phrenic nerve stimulation shorten the duration of ventilator use and improve long-term prognosis?
- What medical problems do participants have when taking non-invasive phrenic nerve stimulation? Researchers will compare non-invasive phrenic nerve stimulation to a sham stimulation to see if non-invasive phrenic nerve stimulation works.
Participants will:
- Receive 14 days of non-invasive phrenic nerve stimulation or sham stimulation
- Visit the clinic or call for follow-up at 90 days of onset
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Transcutaneous electrical phrenic nerve stimulationTranscutaneous electrical phrenic nerve stimulation for 14 days |
| Control group | Sham comparator | Device: Sham (No Treatment)Sham stimulation for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥ 18 years old
- no gender restrictions
- patient diagnosed with acute cerebral infarction (within 30 days of onset) through cranial CT or MRI
- duration of mechanical ventilation ≥ 24 hours
- patient or their legal guardian agrees to participate in the study and signs an informed consent form
Key exclusion criteria (9 listed)
- there are other significant conditions that affect diaphragm function, such as severe malnutrition, irreversible respiratory pump failure caused by medullary or cervical cord injury, and irreversible damage to the phrenic nerve
- significant agitation cannot be combined with transcutaneous electrical phrenic nerve stimulation
- severe skin damage or infection at the electrode placement site
- previous presence of severe lung disease (such as severe COPD, interstitial lung disease, pulmonary embolism, etc.), severe heart failure (NYHA Class IV)
- sepsis or shock requiring high-dose vasopressors
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 |
|---|---|---|
| Transcutaneous electrical phrenic nerve stimulationNon-invasive transcutaneous electrical phrenic nerve stimulation which can cause explicit contraction of the diaphragm, and the stimulation current may be set to 5-30mA depending on the participant's condition. | Device | Intervention group |
| Sham (No Treatment)The stimulation current is set to 0. | Device | Control group |
Primary outcome
Mechanical ventilation duration
Time frame: Successfully weaned from ventilater for 48 hours
The total duration of mechanical ventilation, which is the time difference between starting mechanical ventilation and successfully weaning.
2 secondary outcomes
Successful weaning rate
Time frame: Successfully weaned from ventilater for 48 hours
mRS at 90 days
Time frame: 90 days of symptom onset
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: Yes. After the research is completed and the results are published, the project leader can be contacted to obtain the original data.
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical phrenic nerve stimulation in people with Cerebral Infarction and Mechanical Ventilation, run by Xuanwu Hospital, Beijing at 9 sites in China.
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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linlin Fan (86-010-83198899 ext. 8640, windspring7139@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical ventilation duration (time frame: Successfully weaned from ventilater for 48 hours). 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 21 Aug 2025.