Clinical trial NCT04396249: tVNS for Cognitive Impairments in Community-Dwelling Elderly
Official title: Transcutaneous Vagus Nerve Stimulation for Cognitive Impairments in Community-Dwelling Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Keywords: transcutaneous vagal nerve stimulation (tVNS)
Aging
cognition
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: cognition
timeFrame: up to 2 weeks(end of the intervention)
Secondary outcomes:
measure: cognition
timeFrame: within 1 day after 1st session and 5th session and 1-week follow-up
measure: PHQ-9
timeFrame: up to 2 weeks(end of the intervention),1-week follow-up
measure: GAD-7
timeFrame: up to 2 weeks(end of the intervention),1-week follow-up
measure: Relative power for delta, theta, alpha, sensorimotor and lower beta frequency bands.
timeFrame: up to 2 weeks(end of the intervention)
measure: Antisaccade latency
timeFrame: up to 2 weeks(end of the intervention)
measure: Side-effects of tVNS
timeFrame: At each stimulation session, up to 2 weeks.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Chunbo Li, PHD
role: PRINCIPAL_INVESTIGATOR
References: