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NCT07739329
A Study on the Preventive Effect of Electroacupuncture Combined With Dexmedetomidine in Post-stroke Depression
Conditions: Post-stroke Depression
Sex: All
Healthy volunteers: No
Phase: PHASE4
Enrollment: 231
Sponsor: Min Su
Summary
Post-stroke depression (PSD) is a common neuropsychiatric complication following stroke and has emerged as a major public health concern due to its adverse impact on post-stroke prognosis. Clinical studies have confirmed that early intervention with electroacupuncture can significantly reduce PSD incidence and alleviate depressive severity. Mechanistically, electroacupuncture exerts antidepressant effects through inhibition of the endoplasmic reticulum stress pathway and attenuation of neuronal apoptosis. Dexmedetomidine, a highly selective α₂-adrenergic receptor agonist, not only provides sedation and analgesia but also confers neuroprotective actions, including anti-inflammatory, anti-apoptotic, and blood-brain barrier protective effects. Its efficacy in preventing postpartum depression has been clinically validated. Given the substantial burden of PSD and the limitations of existing preventive approaches, the present study aims to investigate the value of a combined electroacupuncture and dexmedetomidine strategy for PSD prevention, with the goal of developing a safe and effective integrative treatment regimen for this frequent post-stroke complication.
Eligibility Criteria
Inclusion Criteria:
* Ischemic stroke with a disease course of less than 2 weeks;
* Patients with high-risk PSD;
* The patient can accept the treatment plan described in this trial and sign the informed consent form.
Exclusion Criteria:
* Cognitive impairment;
* Severe aphasia or significant language impairment;
* Disturbance of consciousness;
* History of psychiatric disorders, including but not limited to depression, schizophrenia, and bipolar disorder;
* Alcohol or substance dependence;
* Use of sedatives or antipsychotic medications within 2 weeks prior to screening;
* Severe cardiac, hepatic, or renal dysfunction;
* Complicated with acute severe conditions or unstable vital signs;
* Pregnancy or lactation;
* Contraindications or intolerance to electroacupuncture;
* Sick sinus syndrome, severe bradycardia (heart rate \< 50 bpm), second-degree or higher atrioventricular block, permanent pacemaker implantation, severe heart failure, or ejection fraction \< 30%;
* Known allergy to any of the study medications;
* Inability to complete the study procedures due to any unavoidable circumstances.
Source: ClinicalTrials.gov (NCT07739329). StuddyBuddy aggregates publicly available trial information.