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tVNS for Cognitive Impairments in Community-Dwelling Elderly

NCT04396249 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-05-06

No results posted yet for this study

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.

Conditions

  • Aging

Interventions

DEVICE

Active tVNS

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.

DEVICE

Sham tVNS

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.

Sponsors & Collaborators

  • Shanghai Mental Health Center

    lead OTHER

Principal Investigators

  • Chunbo Li, PHD · Shanghai Mental Health Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-21
Primary Completion
2022-09-30
Completion
2023-08-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04396249 on ClinicalTrials.gov