Healthy AgingNCT04877782
Modulating the Locus Coeruleus Function
An observational study of Healthy Aging, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Transcutaneous vagus verne stimulation
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Jan 2021to 5 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy older individuals participating in the study will be recruited from the community.
Who may be able to join
- Average neuropsychological test results in accordance with normative data corrected for age, education and sex
- No substantial memory complaints according to the participant
- Body mass index < 28
- Non-smoking
- Right handedness
- Average/high level of education (minimum 12 years of education)
Who cannot join
- Psychoactive medication use
- Abuse of alcohol and drugs
- Cognitive impairment due to alcohol/drug or other substances abuse
- Recent trans-meridian travel (<2months)
- Night shift work (<1year)
- Diabetes if not stable
Show all 14Show fewer
- Hypo-/hyper-tension, hypo-/hyper-thyroid if not stable
- Hypo-tension due to autonomic dysfunction
- Recent (<5years) or present psychiatric or neurological disorders (anxiety, major depression, schizophrenia, bipolar disorder, psychotic disorder -or treatment for it-, epilepsy, stroke, Alzheimer's disease, Parkinson's disease, multiple sclerosis, brain surgery, brain trauma, electroshock therapy, kidney dialysis, Ménière's disease, brain infections)
- Major vascular disorders (e.g. stroke)
- History of cardiovascular disorders (e.g., severe heart failure, recurrent vasovagal syncopal episodes)
- Major valvular disorders (e.g., prosthetic valve or hemodynamically relevant valvular disease, unilateral or bilateral vagotomy)
- Contraindications for scanning (e.g., brain surgery, cardiac pacemaker, metal implants, claustrophobia, body tattoos, reduced vision even after appropriate optical correction)
- Contraindications for pupil measurements and light exposure (e.g., Cataracts, Glaucoma, detached retina's, eye surgery involving the muscle, penetrating eye wounds, use of cholinesterase inhibitors, anticholinergic eye drop use, droopy eyelids preventing eye measurement).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Boosting a Neuromodulatory System Relevant to Alzheimer's Disease to Enhance Memory
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.
Read the detailed description
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.
- Conditions
- Healthy Aging
- Being tested
- Transcutaneous vagus verne stimulation
- Keywords
- Healthy aging, Transcutaneous vagus nerve stimulation, Magnetic resonance imaging, Locus coeruleus, Memory and attention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous vagus verne stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy older participants | Healthy older participants receiving both stimulation conditions (experimental and placebo) randomized across scanning sessions. Receives: Device: Transcutaneous vagus verne stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the second MRI scanning session (55 minutes)
Secondary outcomes (2)
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.
Measured: Performed from home, 7 to 10 days after the first MRI session and at least 4 days prior to the second session.
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.
Measured: Performed from home, 7 to 10 days after the second MRI session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start14 Jan 2021
- Primary completion25 Sep 2023
- Study completion5 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liege
- Responsible party
- Sponsor
- Investigators
- Heidi IL Jacobs, Dr., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877782
- Sponsor's protocol ID
- NL77066.068.21
- Status last verified
- Oct 2023
- First submitted
- 20 Apr 2021
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosting a Neuromodulatory System Relevant to Alzheimer's Disease to Enhance Memory
- ClinicalTrials.gov ID
- NCT04877782
- Acronym / sponsor ID
- NL77066.068.21
- Conditions
- Healthy Aging
- Keywords
- Healthy aging, Transcutaneous vagus nerve stimulation, Magnetic resonance imaging, Locus coeruleus, Memory and attention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- University of Liege
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy older participants | – | Device: Transcutaneous vagus verne stimulationHealthy older participants receiving both stimulation conditions (experimental and placebo) randomized across scanning sessions. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy older individuals participating in the study will be recruited from the community.
Key inclusion criteria (6 listed)
- Average neuropsychological test results in accordance with normative data corrected for age, education and sex
- No substantial memory complaints according to the participant
- Body mass index < 28
- Non-smoking
- Right handedness
Key exclusion criteria (14 listed)
- Psychoactive medication use
- Abuse of alcohol and drugs
- Cognitive impairment due to alcohol/drug or other substances abuse
- Recent trans-meridian travel (<2months)
- Night shift work (<1year)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous vagus verne stimulationNon-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. | Device | Healthy older participants |
Primary outcome
Pupillometry - Scan session 1
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.
Pupillometry - Scan session 2
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.
Blood oxygen level dependent (BOLD) response - Scan session 1
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.
Blood oxygen level dependent (BOLD) response - Scan session 2
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.
2 secondary outcomes
Performance on the online memory task - Post-session 1
Time frame: Performed from home, 7 to 10 days after the first MRI session and at least 4 days prior to the second session.
Performance on the online memory task - Post-session 2
Time frame: Performed from home, 7 to 10 days after the second MRI session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi IL Jacobs, Dr. principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Aging, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupillometry - Scan session 1 (time frame: During the first MRI scanning session (55 minutes)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.