An interventional study of External trigeminal nerve stimulation and Sham eTNS in Acute Ischemic Stroke, sponsored by Xidian University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Xidian University · Not applicable, Interventional, and Treatment
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 60 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Xidian University is the lead sponsor of 14 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilateral supraorbital regions were selected as the stimulation sites for external trigeminal nerve
Device: External trigeminal nerve stimulation
Device: Sham eTNS
The stimulation parameters were set to 120Hz, 250μs, 30s ON-30s OFF, with the intensity adjusted for patient comfort.
The device delivers a brief electrical current only upon activation and then ceases output.
Response Rate as Assessed by the National Institutes of Health Stroke Scale (NIHSS) at 30 Days
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.
Time frame: NIHSS will be assessed five times within 90 days: at baseline , and on days 5, 30, 60, and 90 post-enrollment.
Change in National Institutes of Health Stroke Scale (NIHSS) scores
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. The change in NIHSS score will be determined by subtracting the baseline score from the score at each subsequent time point.
Time frame: NIHSS will be assessed five times within 90 days: at baseline (prior to participant enrollment), and on days 5, 30, 60, and 90 post-enrollment.
Change in Modified Rankin Scale (mRS) scores
The Modified Rankin Scale (mRS) is employed to assess the status of neurological function recovery in stroke patients. This scale is categorized into seven levels with a scoring range from 0 to 6. Each level corresponds to a specific score; higher scores indicate a poorer prognosis, with a score of 6 signifying death. The change in mRS score will be calculated by subtracting the baseline score from the score at each subsequent time point.
Time frame: mRS will be assessed five times within 90 days: at baseline (prior to participant enrollment), and on days 5, 30, 60, and 90 post-enrollment.
Change in Barthel Index (BI) scores
The Barthel Index (BI) measures the ability of patients to perform daily living activities. Scores range from 0 to 100, with higher scores reflecting greater independence and less dependency. The change in BI score will be calculated by subtracting the baseline score from the score at each subsequent time point.
Time frame: BI will be assessed five times within 90 days: at baseline (prior to participant enrollment), and on days 5, 30, 60, and 90 post-enrollment.
Change in Patient Health Questionnaire-9 (PHQ-9) scores
The Patient Health Questionnaire-9 (PHQ-9) encompasses nine items, each representing a different facet of depressive symptoms. The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms. The change in PHQ-9 score will be determined by subtracting the baseline score from the score at each subsequent time point.
Time frame: PHQ-9 will be assessed four times within 90 days: at baseline (prior to participant enrollment), and on days 30, 60, and 90 post-enrollment.
Change in Generalized Anxiety Disorder Scale (GAD-7) scores
The Generalized Anxiety Disorder Scale (GAD-7) is used to assess the emotional state of patients. The Generalized Anxiety Disorder Scale (GAD-7) comprises seven items, with a total possible score ranging from 0 to 21. An elevated score suggests a more pronounced level of anxiety. The change in GAD-7 score will be determined by subtracting the baseline score from the score at each subsequent time point.
Time frame: GAD-7 will be assessed four times within 90 days: at baseline (prior to participant enrollment), and on days 30, 60, and 90 post-enrollment.
Change in Insomnia Severity Index (ISI) Total Score
The Insomnia Severity Index （ISI） is utilized to assess the severity of insomnia and its impact on physical health, daily function, and quality of life. This scale includes seven items, with a total scoring range from 0 to 28. Higher scores denote more severe insomnia. The change in ISI score will be determined by subtracting the baseline score from the score at each subsequent time point.
Time frame: ISI will be assessed four times within 90 days: at baseline (prior to participant enrollment), and on days 30, 60, and 90 post-enrollment.
Serum Inflammatory Markers
Changes in serum levels of inflammatory markers (e.g., interleukin-6).
Time frame: Baseline and Day 5.
Infarct volume
Infarct volume will be quantified using Magnetic Resonance Imaging.
Time frame: Baseline and Day 5.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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