A Study on the Preventive Effect of Electroacupuncture Combined With Dexmedetomidine in Post-stroke Depression

NCT07739329 | Not Yet Recruiting Phase 4

• 1 other identifier: 2026ECD07
• Study Type: interventional
• Target: 231
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Post-stroke Depression

Outcome Measures

Primary Outcomes (1)

• The incidence of PSD 3 months after stroke

  3 months after stroke

Study Arms (3)

Control group

PLACEBO COMPARATOR

The control group was given an equal dose of normal saline and sham electroacupuncture treatment.

Drug: Normal Saline (NS); Drug: Shame electropuncture

Electroacupuncture group

ACTIVE COMPARATOR

The electroacupuncture group was given an equal dose of normal saline and received electroacupuncture treatment.

Drug: Electropuncture; Drug: Normal Saline (NS)

The electroacupuncture combined with dexmedetomidine group

ACTIVE COMPARATOR

The electroacupuncture combined with dexmedetomidine group was given intranasal titration of dexmedetomidine (original form, 1 μg/kg), and was treated with electroacupuncture simultaneously.

Drug: Dexmedetomidine; Drug: Electropuncture

Interventions

Dexmedetomidine DRUG

Intranasal titration of dexmedetomidine (1μg/kg)

The electroacupuncture combined with dexmedetomidine group

Electropuncture DRUG

Electroacupuncture treatment

Electroacupuncture group; The electroacupuncture combined with dexmedetomidine group

Normal Saline (NS) DRUG

0.9% normal saline

Control group; Electroacupuncture group

Shame electropuncture DRUG

Shame electropuncture treatment

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Min Su: lead

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Yanping Zhang

CONTACT

+8615223049366; zhangyp8415@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07