NCT07911605Not yet recruiting
Short-Term External Trigeminal Nerve Stimulation for Acute Ischemic Stroke: A Sham-Controlled Trial
Sustained Neuroprotective Effects of Short-Term External Trigeminal Nerve Stimulation in Acute Ischemic Stroke: A Randomized, Sham-Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate the efficacy of a 5-day short-course external trigeminal nerve stimulation (eTNS) regimen in patients with acute ischemic stroke. The main questions it aims to answer are whether a 5-day eTNS intervention can significantly improve the neurological response rate at Day 30 compared to sham stimulation, and whether this short-course treatment yields sustained improvements in neuropsychiatric symptoms (depression, anxiety, and insomnia) over a 90-day follow-up period. Researchers will compare the active eTNS group to a sham-controlled group to see if the 5-day stimulation provides a sustained neuroprotective effect. Participants will be randomly assigned (1:1) to receive either active eTNS or sham eTNS for 5 consecutive nights within 72 hours of stroke onset, in addition to standard medical therapy, and will undergo neurological and functional assessments (NIHSS, mRS, BI) at baseline (Day 0), Day 5, Day 30, Day 60, and Day 90, as well as complete neuropsychiatric questionnaires (PHQ-9, GAD-7, and ISI) during the follow-up visits to evaluate their mood and sleep quality. In addition, brain imaging data and blood samples will be collected at baseline (Day 0) and after the 5-day intervention (Day 5) for exploratory analyses of infarct volume and peripheral inflammatory markers.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 27 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 20 Jan 2027
- Lead sponsor
- Xidian University
- Diseases
- Stroke
- NCT number
- NCT07911605
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Nov 2026 to the primary completion date, 20 Jan 2027
- 1 site 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
- Current or recent participation in other neuromodulation stimulation therapies within the past 3 months;
Other illness
- History of ischemic or hemorrhagic stroke within the past 3 months;
Other
- Patients in a comatose state;
- severe comorbidities;
- Pregnant or breastfeeding women;
- Exclusion from trigeminal nerve stimulation: patients with trigeminal neuralgia or facial pain;
Who the study is looking for
- Age over 18 years;
- Medically diagnosed with acute ischemic stroke;
- Ability to receive trigeminal nerve stimulation within 72 hours post-stroke onset;
- NIHSS (National Institutes of Health Stroke Scale) score ≥ 4;
- Signed informed consent form;
- Ability and willingness to comply with the study requirements.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shaanxi provincial people's hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.