Gentle nerve stimulation tested for people recovering from a recent stroke
Tests short nerve stimulation in adults with acute ischemic stroke, compared with sham stimulation.
Plain-language title generated from the registry record
Registry title: Short-Term External Trigeminal Nerve Stimulation for Acute Ischemic Stroke
Key facts
- Where
- Xi'an, ChinaSee the site
Where in China
- Shaanxi provincial people's hospitalXi'an, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xidian University
- Trial code
- NCT07911605
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
Sustained Neuroprotective Effects of Short-Term External Trigeminal Nerve Stimulation in Acute Ischemic Stroke: A Randomized, Sham-Controlled Clinical Trial
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.
Inclusion: 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.
Exclusion: Current or recent participation in other neuromodulation stimulation therapies within the past 3 months; History of ischemic or hemorrhagic stroke within the past 3 months; Patients in a comatose state; severe comorbidities; Pregnant or breastfeeding women; Exclusion from trigeminal nerve stimulation: patients with trigeminal neuralgia or facial pain.