Short-Term External Trigeminal Nerve Stimulation for Acute Ischemic Stroke

Bilateral supraorbital regions were selected as the stimulation sites for external trigeminal nerve

Device: External trigeminal nerve stimulation

No informado en este registro.

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.

Plazo: 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.

Plazo: 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.

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.

Plazo: 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.

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.

Plazo: 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.

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.

Plazo: 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.

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.

Plazo: 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.

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.

Plazo: ISI will be assessed four times within 90 days: at baseline (prior to participant enrollment), and on days 30, 60, and 90 post-enrollment.

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.

Plazo: Baseline and Day 5.

Changes in serum levels of inflammatory markers (e.g., interleukin-6).

Plazo: Baseline and Day 5.

Infarct volume will be quantified using Magnetic Resonance Imaging.

Sustained Neuroprotective Effects of Short-Term External Trigeminal Nerve Stimulation in Acute Ischemic Stroke: A Randomized, Sham-Controlled Clinical Trial