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出境医 / 临床实验 / Transcutaneous Electrical Stimulation of the Vagus Nerve (TESVNR)
Transcutaneous Electrical Stimulation of the Vagus Nerve (TESVNR)
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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cognitive Dysfunction | Device: transcutaneous vagus nerve electric stimulator | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 110 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Prevention |
| 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 |
| Estimated Study Start Date : | July 1, 2019 |
| Estimated Primary Completion Date : | July 1, 2020 |
| Estimated Study Completion Date : | July 1, 2025 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
| Experimental: experiment group |
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)
|
| No Intervention: control group |
Outcome Measures
Primary Outcome Measures :
- Incidence of perioperative neurocognitive disorders [ Time Frame: one month ]make different scale before and after operation to evaluate neurocognitive changes in experiment group and control group.
Eligibility Criteria
| Ages Eligible for Study: | 65 Years to 80 Years (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Contacts
| Contact: Diansan Su | +862168383702 | diansansu@yahoo.com | |
| Contact: Yichen Fan | +86 13482827569 | mcking95@126.com |
Locations
| China, Shanghai | |
| Diansan Su | |
| Shanghai, Shanghai, China, 200127 | |
Sponsors and Collaborators
RenJi Hospital
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 16, 2019 | ||||||||
| First Posted Date ICMJE | June 18, 2019 | ||||||||
| Last Update Posted Date | June 18, 2019 | ||||||||
| Estimated Study Start Date ICMJE | July 1, 2019 | ||||||||
| Estimated Primary Completion Date | July 1, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Incidence of perioperative neurocognitive disorders [ Time Frame: one month ] make different scale before and after operation to evaluate neurocognitive changes in experiment group and control group.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Transcutaneous Electrical Stimulation of the Vagus Nerve | ||||||||
| Official Title ICMJE | The Effect of Transcutaneous Electrical Stimulation of the Vagus Nerve on Reduction of Postoperative Cognitive Dysfunction in Elderly Patients After Hip or Knee Arthroplasty | ||||||||
| 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 | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention |
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| Condition ICMJE | Cognitive Dysfunction | ||||||||
| Intervention ICMJE | 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)
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE |
110 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | July 1, 2025 | ||||||||
| Estimated Primary Completion Date | July 1, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 65 Years to 80 Years (Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03989375 | ||||||||
| Other Study ID Numbers ICMJE | diansansu2018013 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | diansan su, RenJi Hospital | ||||||||
| Study Sponsor ICMJE | RenJi Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | RenJi Hospital | ||||||||
| Verification Date | June 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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