| Registry | NCT07739329 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 231 (Estimated) |
| Sponsor | Min Su (Other) |
| Conditions | Post-stroke Depression |
| Interventions | Dexmedetomidine, Electropuncture, Normal Saline (NS), Shame electropuncture (Drug) |
| Dates | start 2026-08-01 (estimated), primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2026-07-31, last updated 2026-07-31 |
Related Papers Related Patents Related Grants Related Experts
All trials for Post-stroke Depression All trials of Dexmedetomidine All trials of Electropuncture
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control group | Placebo comparator | Drug: Normal Saline (NS); Drug: Shame electropuncture | The control group was given an equal dose of normal saline and sham electroacupuncture treatment. |
| Electroacupuncture group | Active comparator | Drug: Electropuncture; Drug: Normal Saline (NS) | The electroacupuncture group was given an equal dose of normal saline and received electroacupuncture treatment. |
| The electroacupuncture combined with dexmedetomidine group | Active comparator | Drug: Dexmedetomidine; Drug: Electropuncture | The electroacupuncture combined with dexmedetomidine group was given intranasal titration of dexmedetomidine (original form, 1 μg/kg), and was treated with electroacupuncture simultaneously. |
Sex: All
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.