tVNS for Cognitive Impairments in Community-Dwelling Elderly

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04396249
• Other study ID #: 2019-64
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 21, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: May 2022
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: August 1, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Cognitive Dysfunction

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	cognition	Identifying cognitive affected domains by using Cambridge Neuropsychological Test	within 1 day after 1st session and 5th session and 1-week follow-up
Secondary	PHQ-9	Patient Health Questionnaire-9 items,values:0-27, higher score indicates more severe depression symptoms	up to 2 weeks(end of the intervention),1-week follow-up
Secondary	GAD-7	Generalized Anxiety Disorder-7,values:0-21, Higher score indicates more severe anxiety symptoms	up to 2 weeks(end of the intervention),1-week follow-up
Secondary	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.	up to 2 weeks(end of the intervention)
Secondary	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.	up to 2 weeks(end of the intervention)
Secondary	Side-effects of tVNS		At each stimulation session, up to 2 weeks.