Back to resultsTranscutaneous Electrical Stimulation of the Vagus Nerve (TESVNR)
Primary Purpose
Cognitive Dysfunction
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transcutaneous vagus nerve electric stimulator
Sponsored by
About this trial
This is an interventional prevention trial for Cognitive Dysfunction focused on measuring postoperative Cognitive Dysfunction, hip- and knee arthroplasty, transcutaneous vagus nerve stimulation
Eligibility Criteria
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
Sites / Locations
- Diansan Su
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
experiment group
control group
Arm Description
Outcomes
Primary Outcome Measures
Incidence of perioperative neurocognitive disorders
make different scale before and after operation to evaluate neurocognitive changes in experiment group and control group.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03989375
Brief Title
Transcutaneous Electrical Stimulation of the Vagus Nerve
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2019 (Anticipated)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction
Keywords
postoperative Cognitive Dysfunction, hip- and knee arthroplasty, transcutaneous vagus nerve stimulation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experiment group
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
transcutaneous vagus nerve electric stimulator
Intervention Description
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)
Primary Outcome Measure Information:
Title
Incidence of perioperative neurocognitive disorders
Description
make different scale before and after operation to evaluate neurocognitive changes in experiment group and control group.
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diansan Su
Phone
+862168383702
Email
diansansu@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yichen Fan
Phone
+86 13482827569
Email
mcking95@126.com
Facility Information:
Facility Name
Diansan Su
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
12. IPD Sharing Statement
Learn more about this trial
Transcutaneous Electrical Stimulation of the Vagus Nerve
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