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NCT07133932Not yet recruiting

Phrenic Nerve Stimulation for Reducing Ventilation Duration in Acute Cerebral Infarction: A Multicenter Randomized Controlled Trial

Transcutaneous Electrical Phrenic Nerve Stimulation for Reducing Mechanical Ventilation Duration in Acute Cerebral Infarction: A Multicenter Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 21 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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. Can non-invasive phrenic nerve stimulation shorten the duration of ventilator use and improve long-term prognosis? 2. 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: 1. Receive 14 days of non-invasive phrenic nerve stimulation or sham stimulation 2. Visit the clinic or call for follow-up at 90 days of onset

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
590 (estimated)
First submitted
21 Jul 2025
Start date
1 Sept 2025
Primary completion date
31 Dec 2027
Lead sponsor
Xuanwu Hospital, Beijing
Diseases
Stroke
NCT number
NCT07133932

What you commit to

  • Study type: Interventional
  • Planned participants: 590
  • From 1 Sept 2025 to the primary completion date, 31 Dec 2027
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • previous presence of severe lung disease (such as severe COPD, interstitial lung disease, pulmonary embolism, etc.), severe heart failure (NYHA Class IV)

Other illness

  • 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
  • severe skin damage or infection at the electrode placement site
  • the terminal state of the disease or expected survival period does not exceed 7 days

Other

  • significant agitation cannot be combined with transcutaneous electrical phrenic nerve stimulation
  • sepsis or shock requiring high-dose vasopressors
  • pacemaker implantation
  • pregnant or lactating women
  • patients whose family members express their willingness to withdraw for treatment

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Hospital of Fangshan District
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BeijingChinaUnknown status
Beijing Ditan Hospital, Capital Medical University
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BeijingChinaUnknown status
Beijing Daxing District People's Hospital
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BeijingChinaUnknown status
Beijing Tongren Hospital, Capital Medical University
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BeijingChinaUnknown status
Dongzhimen Hospital, Beijing University of Chinese Medicine
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BeijingChinaUnknown status
Xuanwu Hospital, Capital Medical University
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BeijingChinaUnknown status
Sanbo Brain Hospital, Capital Medical University
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BeijingChinaUnknown status
Beijing Hui Min Hospital
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BeijingChinaUnknown status
The First Hospital of Heibei Medical University
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ShijiazhuangChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.