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

July 28, 2026 updated by: Min Su
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

231

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
The control group was given an equal dose of normal saline and sham electroacupuncture treatment.
Drug: Normal Saline (NS)
0.9% normal saline
Drug: Shame electropuncture
Shame electropuncture treatment
Active Comparator: Electroacupuncture group
The electroacupuncture group was given an equal dose of normal saline and received electroacupuncture treatment.
Drug: Normal Saline (NS)
0.9% normal saline
Drug: Electropuncture
Electroacupuncture treatment
Active Comparator: The electroacupuncture combined with dexmedetomidine group
The electroacupuncture combined with dexmedetomidine group was given intranasal titration of dexmedetomidine (original form, 1 μg/kg), and was treated with electroacupuncture simultaneously.
Drug: Electropuncture
Electroacupuncture treatment
Drug: Dexmedetomidine
Intranasal titration of dexmedetomidine (1μg/kg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of PSD 3 months after stroke
Time Frame: 3 months after stroke
3 months after stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Min Su

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 28, 2026

First Submitted That Met QC Criteria

July 28, 2026

First Posted (Actual)

July 31, 2026

Study Record Updates

Last Update Posted (Actual)

July 31, 2026

Last Update Submitted That Met QC Criteria

July 28, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026ECD07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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