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ASSET: Acupoint Stimulation and Endovascular Treatment of Ischemia Stroke

Sponsor
Zhihong LU (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05413460
Collaborator
(none)
58
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

In this prospective randomized controlled trial, the subjects will be assigned to group transcutaneous electrical acupoint stimulation (TEAS) and group control (no intervention). The postoperative outcomes including NIHSS (National Institute of Health stroke scale) score, morbidity and mortality will be evaluated during hospital stay and by one year after surgery.

Condition or Disease Intervention/Treatment Phase
  • Device: transcutaneous electrical acupoint stimulation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
All participants are placed with electrodes at acupoints. The stimulator is put in an opaque box.
Primary Purpose:
Prevention
Official Title:
Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Complications After Endovascular Treatment of Ischemia Stroke
Anticipated Study Start Date :
Jun 30, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: transcutaneous electrical acupoint stimulation

Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.

Device: transcutaneous electrical acupoint stimulation
Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.
Other Names:
  • TEAS

    		•
    No Intervention: Control

    Electrodes are placed at acupoints and connected to the stimulator. But no stimulation is given during surgery.

    Outcome Measures

    Primary Outcome Measures

    1. number of patients with major in-hospital postoperative complications [from end of surgery to discharge from hospital, in an average of 7 days]

      major complications include myocardial infarction, heart failure, respiratory failure, mechanical ventilation, cerebral infarction, delirium and coma

    Secondary Outcome Measures

    1. mortality by 30 days after surgery [from end of surgery to 30 days after surgery, in a total of 30 days]

    2. NIHSS by 30 days after surgery [from end of surgery to 30 days after surgery, in a total of 30 days]

      National Institute of Health stroke scale (NIHSS ), of which minimum and maximum values are 0 and 42 respectively, and higher scores mean a worse outcome.

    3. mortality by 3 months after surgery [from end of surgery to 3 months after surgery, in a total of 3 months]

    4. number of patients with major postoperative complications by 3 months after surgery [from end of surgery to 3 months after surgery, in a total of 3 months]

      major complications include myocardial infarction, heart failure, respiratory failure, mechanical ventilation, cerebral infarction, delirium and coma

    5. mortality by 6 months after surgery [from end of surgery to 6 months after surgery, in a total of 6 months]

    6. number of patients with major postoperative complications by 6 months after surgery [from end of surgery to 6 months after surgery, in a total of 6 months]

      major complications include myocardial infarction, heart failure, respiratory failure, mechanical ventilation, cerebral infarction, delirium and coma

    7. duration of postoperative in-hospital stay [from end of surgery to discharge from hospital, in an average of 7 days]

    8. serum interleukin-6 level at the end of the surgery [at end of the surgery]

    9. serum tumor necrosis factor-α level at the end of the surgery [at end of the surgery]

    10. episodes of hypotension during surgery [from start of surgery to end of surgery, in an average of 2 hours]

      hypotension is defined as mean arterial pressure decreased by more than 20% of the baseline and persisting more than 1 minute

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age ≥18 years

    • patients with ischemia stroke

    • patients scheduled for endovascular treatment

    Exclusion Criteria:

    • patients with endotracheal intubation

    • patients with intracranial hemorrhage

    • patients with posterior circulation infarction

    • patients with Glasgow score less than 8

    • patients with National Institute of Health stroke scale (NIHSS) less than 10

    • patients with agitation or epilepsy

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Zhihong LU

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Zhihong LU, Professor, Air Force Military Medical University, China
    ClinicalTrials.gov Identifier:
    NCT05413460
    Other Study ID Numbers:
    • XJH-A-20200730
    First Posted:
    Jun 10, 2022
    Last Update Posted:
    Jun 10, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zhihong LU, Professor, Air Force Military Medical University, China
    transcutaneous electrical acupoint stimulation
    endovascular treatment
    Additional relevant MeSH terms:
    Stroke
    Ischemic Stroke
    Ischemia

    Study Results

    No Results Posted as of Jun 10, 2022