Maastricht University
Maastricht, 6229 ET, Netherlands
NCT Number: NCT04877782
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.
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Notify Me60 year–80 year
All sexes
Observational
Maastricht, 6229 ET, Netherlands
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: During the first MRI scanning session (55 minutes)
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.
Time frame: During the second MRI scanning session (55 minutes)
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.
Time frame: During the first MRI scanning session (55 minutes)
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.
Time frame: During the second MRI scanning session (55 minutes)
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.
Time frame: Performed from home, 7 to 10 days after the first MRI session and at least 4 days prior to the second session.
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.
Time frame: Performed from home, 7 to 10 days after the second MRI session.
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.
Maastricht University Medical Center
Other
Boosting a Neuromodulatory System Relevant to Alzheimer's Disease to Enhance Memory
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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