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NCT03989375 Clinical Trial

Transcutaneous Electrical Stimulation of the Vagus Nerve

Cognitive Dysfunction Clinical Trial

— TESVNR  

Official title:
The Effect of Transcutaneous Electrical Stimulation of the Vagus Nerve on Reduction of Postoperative Cognitive Dysfunction in Elderly Patients After Hip or Knee Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03989375
Other study ID # diansansu2018013
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2019
Est. completion date July 1, 2025

Study information
Verified date June 2019
Source RenJi Hospital
Contact Diansan Su
Phone +862168383702
Email diansansu@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluate the cognitive functions of patient after hip or kneel replacement.Half of the patient will receive transcutaneous vagus nerve electrical stimulation during the surgery while the other half will get placebo therapy

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 110
Est. completion date July 1, 2025
Est. primary completion date July 1, 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years to 80 Years
Eligibility Inclusion Criteria:

- over 65 years old

- ability to communication

- hip or kneel replacement

- willing to participate in the study

- ASA I-II

Exclusion Criteria:

- with cerebral disorders or disease

- cognitive impairment before surgery

- with mental disease

- unable to communication

- severe eyes or ears impairment

- surgery performed in the past 30 days

- Bradycardia,II°AVB,III°AVB,severe heart, liver and kidney dysfunction

- severe skin disease

- refuse to enter the study

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• transcutaneous vagus nerve electric stimulator
The stimulator that can be attached to ears of the patient.We suppose that this device can reduce the incidence of perioperative neurocognitive disorders(PND)

Locations
Country Name City State
China Diansan Su Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of perioperative neurocognitive disorders make different scale before and after operation to evaluate neurocognitive changes in experiment group and control group. one month
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