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tVNS for Cognitive Impairments in Community-Dwelling Elderly

S

Shanghai Mental Health Center

Status

Unknown

Conditions

Aging

Treatments

Device: Active tVNS
Device: Sham tVNS

Study type

Interventional

Funder types

Other

Identifiers

NCT04396249
2019-64

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

65 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

120 participants in 2 patient groups

Active tVNS group
Experimental group
Description:
The active tVNS group will be stimulated with 10 sessions of active transcutaneous vagal nerve stimulation (tVNS)
Treatment:
Device: Active tVNS
Sham tVNS group
Sham Comparator group
Description:
The sham tVNS group will be stimulated with 10 sessions of sham transcutaneous vagal nerve stimulation (tVNS)
Treatment:
Device: Sham tVNS

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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