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AgingNCT04396249

tVNS for Cognitive Impairments in Community-Dwelling Elderly

A study testing Active tVNS in people with Aging, run by Shanghai Mental Health Center at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this study is to explore the effects of transcutaneous vagus nerve stimulation(tVNS) on improving cognition in community-dwelling elderly people. The study will recruit 120 subjects. Participants will undergo baseline cognitive assessment, EEG and eye tracking. Read more about this study

Who is it for?
Ages 65 to 75 years
Conditions the study is for
Aging
What is being tested?
Active tVNS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteChina
Study dates
21 May 2021to 1 Aug 2023
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 75 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 65≤age≤75 years old; (2) years of education ≥1 year; (3) normal daily life ability; (4) total score of The Chinese version of Mini-Mental State Examination (MMSE) : Non-illiterate group (not graduated from elementary school)> 14 points, elementary school group> 19 points, middle school and above group> 24 points).

Who cannot join

  • People with obvious hearing, vision problems or communication difficulties; (2) People with obvious cognitive dysfunction (such as Alzheimer's disease); (3) People with serious medical diseases (such as heart disease, uremia, severe diarrhea) ; (4) In the stage of radiotherapy and chemotherapy; (5) People with serious neurological diseases (such as Parkinson's disease, infectious encephalopathy); (6) Patients with mental diseases (such as schizophrenia, depression, etc.); 7) Patients with substance abuse or alcohol dependence; (8) patients with implantable medical devices such as cardiac pacemakers; (9) patients with scars or inflammation on the ear skin.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Mental Health Center

    Shanghai, Shanghai Municipality, 200030

Other trials in China

About this study

Official title: Transcutaneous Vagus Nerve Stimulation for Cognitive Impairments in Community-Dwelling Elderly

The goal of this study is to explore the effects of transcutaneous vagus nerve stimulation(tVNS) on improving cognition in community-dwelling elderly people. The study will recruit 120 subjects. Participants will undergo baseline cognitive assessment, EEG and eye tracking. Participants will be randomized to tVNS group and sham group. All subjects will repeat the baseline assessments after 1st session, 5th session，10th session and within 3 days after 10th session.

Read the detailed description

Transcutaneous vagal nerve stimulation (tVNS) is a non-invasive neurostimulation technology.Recent studies have found that tVNS may involve in the regulation of cognition and improve the memory of the elderly.However, due to the limited number of studies, the effect of tVNS on improving cognitive function and stimulation parameters are currently unclear.

To investigate the effects of tVNS on improving cognition in community-dwelling elderly people, our study will recruit 120 subjects. Participants will undergo baseline cognitive assessment, EEG and eye tracking. Active vs. sham treatment will be randomly assigned in a 1:1 fashion in groups using computer generated lists. Subjects and evaluators will be blind to treatment. All subjects will repeat the baseline assessments after 1st session, 5th session，10th session and within 3 days after 10th session.

Conditions
Aging
Being tested
Active tVNS, Sham tVNS
Keywords
transcutaneous vagal nerve stimulation (tVNS), Aging, cognition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active tVNSDevice

    One electrode tip is used as their common terminal, and the other two electrode tips are respectively connected to the skin surfaces of the auricle and the external auditory meatus. Each subject will have 10 active tVNS sessions.The active tVNS group will be stimulated with a 2 mA current for 30 minutes.

  • Sham tVNSDevice

    Each subject will have 10 sham tVNS sessions.The sham tVNS group will be stimulated with a 2 mA current for 30 minutes. Except for the stimulation site, other parameters are the same as active group.

Study groups in NCT04396249
Study groupRoleWhat they receive
Active tVNS groupExperimentalThe active tVNS group will be stimulated with 10 sessions of active transcutaneous vagal nerve stimulation (tVNS)
Receives: Device: Active tVNS
Sham tVNS groupSham comparatorThe sham tVNS group will be stimulated with 10 sessions of sham transcutaneous vagal nerve stimulation (tVNS)
Receives: Device: Sham tVNS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cognition

    Identifying cognitive affected domains by using Cambridge Neuropsychological Test Automated Battery (CANTAB) (Memory:PAL、DMS、PRM; Executive Function : RTI、MOT)

    Measured: up to 2 weeks(end of the intervention)

Secondary outcomes (6)

  1. cognition

    Identifying cognitive affected domains by using Cambridge Neuropsychological Test

    Measured: within 1 day after 1st session and 5th session and 1-week follow-up

  2. PHQ-9

    Patient Health Questionnaire-9 items，values:0-27, higher score indicates more severe depression symptoms

    Measured: up to 2 weeks(end of the intervention),1-week follow-up

  3. GAD-7

    Generalized Anxiety Disorder-7，values:0-21, Higher score indicates more severe anxiety symptoms

    Measured: up to 2 weeks(end of the intervention),1-week follow-up

  4. Relative power for delta, theta, alpha, sensorimotor and lower beta frequency bands.

    The power spectral density was calculated to extract the relative power for each frequency band and estimated as a log-ratio.

    Measured: up to 2 weeks(end of the intervention)

  5. Antisaccade latency

    We used an EyeLink Desktop 1000 eye-tracker to collect the information of eye movements.The latency of the saccade was measured from the onset of the saccade to the target onset.

    Measured: up to 2 weeks(end of the intervention)

  6. Side-effects of tVNS

    Measured: At each stimulation session, up to 2 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2020
  2. Study start21 May 2021
  3. Primary completion30 Sep 2022 (estimated)
  4. Study completion1 Aug 2023 (estimated)

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04396249
Sponsor's protocol ID
2019-64
Status last verified
May 2022
First submitted
10 May 2020
Last updated
6 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Active tVNS in people with Aging, run by Shanghai Mental Health Center 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 1 inclusion and 1 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 6 May 2022. 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. Some participants in this study may receive a placebo. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cognition (time frame: up to 2 weeks(end of the intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04396249.

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 6 May 2022.

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