tVNS for Cognitive Impairments in Community-Dwelling Elderly

Not Applicable

• Conditions: Aging
• Interventions: Device: Active tVNS; Device: Sham tVNS

• Registration Number: NCT04396249
• Lead Sponsor: Shanghai Mental Health Center

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.

Study Timeline

• Study First Submitted: 2020-05-10
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-20
• Study Start: 2021-05-21
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-06
• Primary Completion: 2022-09-30
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active tVNS group	Active tVNS	The active tVNS group will be stimulated with 10 sessions of active transcutaneous vagal nerve stimulation (tVNS)
Sham tVNS group	Sham tVNS	The sham tVNS group will be stimulated with 10 sessions of sham transcutaneous vagal nerve stimulation (tVNS)

Primary Outcome Measures

Name	Time	Method
cognition	up to 2 weeks(end of the intervention)	Identifying cognitive affected domains by using Cambridge Neuropsychological Test Automated Battery (CANTAB) (Memory:PAL、DMS、PRM; Executive Function : RTI、MOT)

Secondary Outcome Measures

Name	Time	Method
Side-effects of tVNS	At each stimulation session, up to 2 weeks.
GAD-7	up to 2 weeks(end of the intervention),1-week follow-up	Generalized Anxiety Disorder-7，values:0-21, Higher score indicates more severe anxiety symptoms
cognition	within 1 day after 1st session and 5th session and 1-week follow-up	Identifying cognitive affected domains by using Cambridge Neuropsychological Test
PHQ-9	up to 2 weeks(end of the intervention),1-week follow-up	Patient Health Questionnaire-9 items，values:0-27, higher score indicates more severe depression symptoms
Antisaccade latency	up to 2 weeks(end of the intervention)	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.
Relative power for delta, theta, alpha, sensorimotor and lower beta frequency bands.	up to 2 weeks(end of the intervention)	The power spectral density was calculated to extract the relative power for each frequency band and estimated as a log-ratio.

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China