NCT04396249

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

May 21, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

May 6, 2022

Status Verified

May 1, 2022

Enrollment Period

1.4 years

First QC Date

May 10, 2020

Last Update Submit

May 5, 2022

Conditions

Aging

Keywords

transcutaneous vagal nerve stimulation (tVNS)Agingcognition

Outcome Measures

Primary Outcomes (1)

  • cognition

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

    up to 2 weeks(end of the intervention)

Secondary Outcomes (6)

  • cognition

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

  • PHQ-9

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

  • GAD-7

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

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

    up to 2 weeks(end of the intervention)

  • Antisaccade latency

    up to 2 weeks(end of the intervention)

  • +1 more secondary outcomes

Study Arms (2)

Active tVNS group

EXPERIMENTAL

The active tVNS group will be stimulated with 10 sessions of active transcutaneous vagal nerve stimulation (tVNS)

Device: Active tVNS

Sham tVNS group

SHAM COMPARATOR

The sham tVNS group will be stimulated with 10 sessions of sham transcutaneous vagal nerve stimulation (tVNS)

Device: Sham tVNS

Interventions

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.

Active tVNS group
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.

Sham tVNS group

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • (1) 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).

You may not qualify if:

  • (1) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

Study Officials

  • Chunbo Li, PHD

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2020

First Posted

May 20, 2020

Study Start

May 21, 2021

Primary Completion

September 30, 2022

Study Completion

August 1, 2023

Last Updated

May 6, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)