Transcutaneous Electrical Stimulation of the Vagus Nerve | NCT03989375

Studies
Transcutaneous Electrical Stimulation of the Vagus Nerve

NCT03989375

Sponsor

RenJi Hospital

Status

Unknown status

Last Update Posted

Jun 18, 2019Actual

Enrollment

110Estimated

Phase

Not Applicable

Conditions

Cognitive Dysfunction

Interventions

transcutaneous vagus nerve electric stimulator

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2019Estimated

Primary Completion Date

Jul 1, 2020Estimated

Completion Date

Jul 1, 2025Estimated

First Submitted Date

Jun 16, 2019

First Submission Date that Met QC Criteria

Jun 16, 2019

First Posted Date

Jun 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2019

Last Update Posted Date

Jun 18, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experiment group	Experimental		Device: transcutaneous vagus nerve electric stimulator
control group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transcutaneous vagus nerve electric stimulator	Device	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)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of perioperative neurocognitive disorders	make different scale before and after operation to evaluate neurocognitive changes in experiment group and control group.	one month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

80 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Diansan Su	Contact	+862168383702		diansansu@yahoo.com
Yichen Fan	Contact	+86 13482827569		mcking95@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Diansan Su		Shanghai	Shanghai Municipality	200127	China

Condition Browse Module

MeSH Terms

ID	Term
D060825	Cognitive Dysfunction
D000079690	Postoperative Cognitive Complications

Ancestor Terms

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided