Transcutaneous Electrical Stimulation of the Vagus Nerve

NCT ID: NCT03989375

Last Updated: 2019-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2025-07-01

Brief Summary

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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

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Conditions

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Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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experiment group

Group Type EXPERIMENTAL

transcutaneous vagus nerve electric stimulator

Intervention Type 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)

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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diansan su

Professer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Diansan Su

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Diansan Su

Role: CONTACT

+862168383702

Yichen Fan

Role: CONTACT

+86 13482827569

Other Identifiers

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diansansu2018013

Identifier Type: -

Identifier Source: org_study_id

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