Short-Term External Trigeminal Nerve Stimulation for Acute Ischemic Stroke: A Sham-Controlled Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

External trigeminal nerve stimulation: The stimulation parameters were set to 120Hz, 250μs, 30s ON-30s OFF, with the intensity adjusted for patient comfort.

Sham eTNS: The device delivers a brief electrical current only upon activation and then ceases output.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Response rate at 30 days — NIHSS will be assessed five times within 90 days: at baseline , and on days 5, 30, 60, and 90 post-enrollment.
  The National Institutes of Health Stroke Scale (NIHSS) is employed to evaluate the extent of functional impairment caused by stroke. Comprising 11 test items, the scale's scoring ranges from 0 to 42. Higher scores are indicative of more severe strokes and are positively correlated with the volume of cerebral damage caused by the stroke. Response is defined as a decrease in NIHSS (National Institutes of Health Stroke Scale) score by 4 points or more, or a decrease to 0-1 points after treatment. The response rate is the proportion of participants whose NIHSS scores decrease by 4 points or more, or to 0-1 points, compared to baseline.

Trial sites (1)

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