Study of the Effects of the Non-invasive Trigeminal Nerve Stimulation on Ischemic Stroke Patients
NCT Number: NCT06540417
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Ischemic Stroke
Interventions: DEVICE: External trigeminal nerve stimulation
Sponsor: Xidian University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-12-01
Completion Date: 2024-10-20
Locations: Xidian University, Xi'an, Shaanxi, China

Summary:
In patients with ischemic stroke, the primary focus revolves around enhancing the neuroprotective and rehabilitative effects of external trigeminal nerve stimulation (eTNS) and elucidating its underlying central mechanisms. Through clinical trials and neuroimaging studies, this research endeavors to 1) investigate the clinical impact of TNS on brain protection and 2) rehabilitation acceleration in ischemic stroke patients, while concurrently exploring the potential central nervous mechanisms involved. The ultimate aim is to contribute a novel therapeutic approach to the clinical management of acute ischemic stroke.

Primary Outcome Measures: Response rate after five days of treatment, 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., 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.
Secondary Outcome Measures: Infarct volume growth rate, Defined as the difference in infarct volume on day 5 compared to baseline, divided by the baseline infarct volume., Imaging data will be collected twice within 90 days: at baseline (prior to participant enrollment) and on the fifth day of treatment.|Change in 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., 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 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., 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 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., 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 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., 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 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., 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 ISI scores, 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., ISI will be assessed four times within 90 days: at baseline (prior to participant enrollment), and on days 30, 60, and 90 post-enrollment.|Correlation Between Time to Treatment and Intervention Outcomes, The correlation between the hours from stroke onset to treatment and intervention outcomes (defined by NIHSS score improvement or no improvement) will be assessed., The time from stroke onset to treatment will be recorded prior to enrollment.|Correlation Between Blood Inflammatory Markers and Stroke Severity and Intervention Outcomes, Blood samples will be collected at baseline (prior to participant enrollment) to measure levels of TNF-α and IL-6 (pg/ml). The correlation between these levels and intervention outcomes (defined by NIHSS score improvement or no improvement) will be analyzed., Blood samples will be collected at baseline (prior to participant enrollment)|Correlation Between Medical History and Intervention Outcomes, Participants' medical history, including diabetes, hypertension, coronary artery disease, and history of cerebral infarction, will be collected at baseline to examine the relationship between medical history and the efficacy of the intervention., Medical History will be collected at baseline (prior to participant enrollment)