Back to resultstVNS for Cognitive Impairments in Community-Dwelling Elderly
Primary Purpose
Aging
Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Active tVNS
Sham tVNS
Sponsored by
About this trial
This is an interventional prevention trial for Aging focused on measuring transcutaneous vagal nerve stimulation (tVNS), Aging, cognition
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.
Sites / Locations
- Shanghai Mental Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active tVNS group
Sham tVNS group
Arm Description
The active tVNS group will be stimulated with 10 sessions of active transcutaneous vagal nerve stimulation (tVNS)
The sham tVNS group will be stimulated with 10 sessions of sham transcutaneous vagal nerve stimulation (tVNS)
Outcomes
Primary Outcome Measures
cognition
Identifying cognitive affected domains by using Cambridge Neuropsychological Test Automated Battery (CANTAB) (Memory:PAL、DMS、PRM; Executive Function : RTI、MOT)
Secondary Outcome Measures
cognition
Identifying cognitive affected domains by using Cambridge Neuropsychological Test
PHQ-9
Patient Health Questionnaire-9 items，values:0-27, higher score indicates more severe depression symptoms
GAD-7
Generalized Anxiety Disorder-7，values:0-21, Higher score indicates more severe anxiety symptoms
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.
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.
Side-effects of tVNS
Full Information
NCT ID
NCT04396249
First Posted
May 10, 2020
Last Updated
May 5, 2022
Sponsor
Shanghai Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT04396249
Brief Title
tVNS for Cognitive Impairments in Community-Dwelling Elderly
Official Title
Transcutaneous Vagus Nerve Stimulation for Cognitive Impairments in Community-Dwelling Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging
Keywords
transcutaneous vagal nerve stimulation (tVNS), Aging, cognition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active tVNS group
Arm Type
Experimental
Arm Description
The active tVNS group will be stimulated with 10 sessions of active transcutaneous vagal nerve stimulation (tVNS)
Arm Title
Sham tVNS group
Arm Type
Sham Comparator
Arm Description
The sham tVNS group will be stimulated with 10 sessions of sham transcutaneous vagal nerve stimulation (tVNS)
Intervention Type
Device
Intervention Name(s)
Active tVNS
Intervention Description
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
Intervention Name(s)
Sham tVNS
Intervention Description
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.
Primary Outcome Measure Information:
Title
cognition
Description
Identifying cognitive affected domains by using Cambridge Neuropsychological Test Automated Battery (CANTAB) (Memory:PAL、DMS、PRM; Executive Function : RTI、MOT)
Time Frame
up to 2 weeks(end of the intervention)
Secondary Outcome Measure Information:
Title
cognition
Description
Identifying cognitive affected domains by using Cambridge Neuropsychological Test
Time Frame
within 1 day after 1st session and 5th session and 1-week follow-up
Title
PHQ-9
Description
Patient Health Questionnaire-9 items，values:0-27, higher score indicates more severe depression symptoms
Time Frame
up to 2 weeks(end of the intervention),1-week follow-up
Title
GAD-7
Description
Generalized Anxiety Disorder-7，values:0-21, Higher score indicates more severe anxiety symptoms
Time Frame
up to 2 weeks(end of the intervention),1-week follow-up
Title
Relative power for delta, theta, alpha, sensorimotor and lower beta frequency bands.
Description
The power spectral density was calculated to extract the relative power for each frequency band and estimated as a log-ratio.
Time Frame
up to 2 weeks(end of the intervention)
Title
Antisaccade latency
Description
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.
Time Frame
up to 2 weeks(end of the intervention)
Title
Side-effects of tVNS
Time Frame
At each stimulation session, up to 2 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunbo Li, PHD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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tVNS for Cognitive Impairments in Community-Dwelling Elderly
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