Short-Term outside-in nerve stimulation for acute ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, sham-controlled study, adults with acute ischemic stroke within 72 hours of onset receive either active external trigeminal nerve stimulation for five consecutive nights or a sham procedure, in addition to standard care. Neurological and functional outcomes (NIHSS, mRS, BI) are measured at baseline, Day 5, Day 30, Day 60, and Day 90 to see if the treatment provides neuroprotection and reduces neuropsychiatric symptoms. The trial aims to determine if the short course can improve early response and sustain benefits over three months. Participants must meet criteria including age, NIHSS score, and ability to consent, while certain stroke histories or comorbid conditions exclude enrollment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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;
* Current or recent participation in other neuromodulation stimulation therapies within the past 3 months;

Where it's running

• Shaanxi Provincial People' s Hospital
  Xi'an, China Recruiting

Study contacts

• Study coordinator: Rui Zhao
• Email: zhaorui861221@163.com
• Phone: 86-029-85251331-2610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.