tVNS for Cognitive Impairments in Community-Dwelling Elderly

NCT ID: NCT04396249

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-21
• Study Completion Date: 2023-08-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Active tVNS group

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

Group Type: EXPERIMENTAL

Active tVNS

Intervention Type: DEVICE

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 tVNS group

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

Group Type: SHAM_COMPARATOR

Sham tVNS

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

(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).

Exclusion Criteria

(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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chunbo Li, PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

2019-64

Identifier Type: -

Identifier Source: org_study_id