Clinical observation of auricular nail electroacupuncture in the treatment of insomnia after stroke and Research on brain mechanism of multimodal magnetic resonance

Authors
Category Primary study
Registry of TrialsInternational Traditional Medicine Clinical Trial Registry
Year 2025
INTERVENTION: Treatment group:Basic Treatment for Stroke: According to the Chinese Clinical Management Guidelines for Cerebrovascular Diseases, this includes pharmacotherapy such as antiplatelet agents and lipid‐lowering drugs (including Aspirin enteric‐coated tablets 100mg qd, Atorvastatin 20mg qn, etc.), alongside intervention for risk factors like blood pressure and blood glucose. Conventional Basic Sleep Aid Medication: Oral administration of 1 mg of eszopiclone tablets at bedtime. Auricular vagus nerve stimulation device (positioned at the patients optimal location, primarily stimulating the auricular vagus nerve branch entering the auricle from the posterior‐inferior region of the external auditory canal, anatomically defined as the posterior‐inferior external auditory canal, and targeting the auricular acupuncture points for the heart and kidney meridians). Stimulation parameters and duration: Employ sparse‐dense waveform with a pulse frequency of 4/20Hz (dense wave 20Hz, sparse wave 4Hz), current intensity 3‐14mA (maximum current =50mA), adjusted based on patient tolerance. Administer once daily for 30 minutes, 5 days per week, over 4 weeks.;Control group:Basic Treatment for Stroke: According to the Chinese Clinical Management Guidelines for Cerebrovascular Diseases, both groups received basic treatment, including antiplatelet and lipid‐lowering medications (such as enteric‐coated aspirin tablets 100mg qd, atorvastatin 20mg qn, etc.), along with interventions for risk factors like blood pressure and blood glucose. Conventional Basic Sleep‐Aid Medication: Oral administration of 1 mg of eszopiclone tablets at bedtime. Control Group (Placebo Stimulation Group): Utilized the same treatment device as the treatment group, primarily stimulating the upper concha at the midpoint of t CONDITION: Insomnia after stroke PRIMARY OUTCOME: Pittsburgh Sleep Quality Index Scale; SECONDARY OUTCOME: Traditional Chinese Medicine Syndrome Scoring;National Institutes of Health Stroke Scale;Activities of Daily Living Assessment Scale;17‐Item Hamilton Anxiety Rating Scale;14‐Item Hamilton Anxiety Rating Scale; INCLUSION CRITERIA: 1.Inclusion Criteria for Post‐Stroke Insomnia Patients:: (1) (1) Meets the diagnostic criteria for ischemic stroke outlined in the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke (2023) and the diagnostic criteria for insomnia outlined in the Chinese Guidelines for the Diagnosis and Treatment of Insomnia in Adults (2023 Edition); (2) Age 40 = age = 80, no gender restriction; (3) Insomnia onset occurring more than 2 weeks after acute stroke; (4) Pittsburgh Sleep Quality Inde X(PSQI) score > 7 points; (5) Possess normal consciousness and ability to cooperate with all observational assessments; (6) Must sign an informed consent form, voluntarily participate in the study, and ensure no involvement in other studies during the treatment period. 2. Inclusion Criteria for Healthy Control Group: (1) Right‐handed; (2) Age 40 = age = 80 years, no gender restrictions; (3) Pittsburgh Sleep Quality Inde X(PSQI) score = 7;
Epistemonikos ID: ab3b60e4492606beea98c7051e4a4b9b7b1ff0e0
First added on: Jan 24, 2026