Cognitive DysfunctionTESVNRNCT03989375
Transcutaneous Electrical Stimulation of the Vagus Nerve
A study testing transcutaneous vagus nerve electric stimulator in people with Cognitive Dysfunction, run by RenJi Hospital at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- transcutaneous vagus nerve electric stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- over 65 years old
- ability to communication
- hip or kneel replacement
- willing to participate in the study
- ASA I-II
Who cannot join
- 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
Show all 9Show fewer
- Bradycardia，II°AVB，III°AVB，severe heart, liver and kidney dysfunction
- severe skin disease
- refuse to enter the study
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Cognitive Dysfunction
- Being tested
- transcutaneous vagus nerve electric stimulator
- Keywords
- postoperative Cognitive Dysfunction, hip- and knee arthroplasty, transcutaneous vagus nerve stimulation
- Medical subject headings
- Cognitive Dysfunction, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous vagus nerve electric stimulatorDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| experiment group | Experimental | Not described Receives: Device: transcutaneous vagus nerve electric stimulator |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of perioperative neurocognitive disorders
make different scale before and after operation to evaluate neurocognitive changes in experiment group and control group.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start1 Jul 2019 (estimated)
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, diansan su, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989375
- Sponsor's protocol ID
- diansansu2018013
- Acronym
- TESVNR
- Status last verified
- Jun 2019
- First submitted
- 16 Jun 2019
- Last updated
- 18 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03989375
- Acronym / sponsor ID
- TESVNR / diansansu2018013
- Conditions
- Cognitive Dysfunction
- Keywords
- postoperative Cognitive Dysfunction, hip- and knee arthroplasty, transcutaneous vagus nerve stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 18 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experiment group | Experimental | Device: transcutaneous vagus nerve electric stimulator |
| control group | No intervention | – |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- over 65 years old
- ability to communication
- hip or kneel replacement
- willing to participate in the study
- ASA I-II
Key exclusion criteria (9 listed)
- with cerebral disorders or disease
- cognitive impairment before surgery
- with mental disease
- unable to communication
- severe eyes or ears impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous vagus nerve electric stimulatorThe stimulator that can be attached to ears of the patient.We suppose that this device can reduce the incidence of perioperative neurocognitive disorders(PND) | Device | experiment group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous vagus nerve electric stimulator in people with Cognitive Dysfunction, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diansan Su (+862168383702, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of perioperative neurocognitive disorders (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.