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| Name | Class |
|---|---|
| University of Liege | OTHER |
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The purpose of this study is to investigate the impact of transcutaneous vagus nerve stimulation (tVNS) on specific brain regions involved in memory and attention processes.
tVNS is a non-invasive and non-pharmacological technique known for targeting the locus coeruleus, a small subcortical nucleus in the brain thought to be involved in the earliest stages of Alzheimer's disease. This nucleus also plays a role in numerous cognitive functions, comprising memory and attention.
This study is an observational MRI study with a pseudo-randomized single blind cross-over design. The population consists of 30 healthy human volunteers from 60 to 80 years old. These healthy older individuals will be recruited from the community.
After being informed about the study protocol and the potential risks, subjects will be given 1 week to consider their participation.
All participants giving written informed consent will be included in the study. The first session will consist in neuropsychological assessments and a task practice session in the dummy scanner in order to get familiar with the environment. Participants meeting the eligibility criteria will be included for the next sessions.
The second and third sessions are MRI scanning sessions including transcutaneous vagus nerve stimulation. Both the placebo and experimental stimulation conditions will be randomized in a single-blind manner across scanning sessions.
About 7 to 10 weeks after each scanning session and at least 4 days previous to the next MRI session, participant will be asked to fill in an online memory test for assessing potential outlasting effects of the stimulation technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy older participants | Healthy older participants receiving both stimulation conditions (experimental and placebo) randomized across scanning sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous vagus verne stimulation | Device | Non-invasive and short electrical stimulation by placing the stimulating electrode at the cymba conchae of the left ear. The reference electrode is placed near the left cymba conchae. It provides a light tingling, massaging feeling in the ear. |
| Measure | Description | Time Frame |
|---|---|---|
| Pupillometry - Scan session 1 | Measure of pupil size variations during functional tasks. It can be used as a proxy for measuring arousal-related state transitions in brain activity and it allows for a reliable detection of the locus coeruleus activity. | During the first MRI scanning session (55 minutes) |
| Pupillometry - Scan session 2 | Measure of pupil size variations during functional tasks. It can be used as a proxy for measuring arousal-related state transitions in brain activity and it allows for a reliable detection of the locus coeruleus activity. | During the second MRI scanning session (55 minutes) |
| Blood oxygen level dependent (BOLD) response - Scan session 1 | This BOLD signal reflects brain activity during the functional tasks. The study focuses on the BOLD-signal in the locus coeruleus and task-relevant networks during the memory and the vigilance tasks. | During the first MRI scanning session (55 minutes) |
| Blood oxygen level dependent (BOLD) response - Scan session 2 | This BOLD signal reflects brain activity during the functional tasks. The study focuses on the BOLD-signal in the locus coeruleus and task-relevant networks during the memory and the vigilance tasks. | During the second MRI scanning session (55 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Performance on the online memory task - Post-session 1 | Total accuracy on the face-name association task (from 0 to 100%); Mean reaction time on the face-name association task (from 0 to 4 seconds). The higher the total accuracy and the lower the mean reaction time, the better the outcome measure. | Performed from home, 7 to 10 days after the first MRI session and at least 4 days prior to the second session. |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy older individuals participating in the study will be recruited from the community.
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| Name | Affiliation | Role |
|---|---|---|
| Heidi IL Jacobs, Dr. | Maastricht University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University | Maastricht | 6229 ET | Netherlands |
All collected IPD during the study are to be shared with the lab's members and according to the pre-defined agreements between Maastricht University and the University of Liège.
Previously mentioned IPD and additional supporting information will be shared from the end of the study ad will be available for a time period of 15 years.
Data will be accessible only by lab members, through an access to the encrypted server where all data are stored.
All kind of analyses might be performed on the available data.
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| Performance on the online memory task - Post-session 2 | Total accuracy on the face-name association task (from 0 to 100%); Mean reaction time on the face-name association task (from 0 to 4 seconds). The higher the total accuracy and the lower the mean reaction time, the better the outcome measure. | Performed from home, 7 to 10 days after the second MRI session. |