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Modulating the Locus Coeruleus Function

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ClinicalTrials.gov Identifier: NCT04877782
Recruitment Status : Not yet recruiting
First Posted : May 7, 2021
Last Update Posted : September 5, 2021
Sponsor:
Collaborator:
University of Liege
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
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Brief 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 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.


Condition or disease Intervention/treatment
Healthy Aging Device: Transcutaneous vagus verne stimulation

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
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Boosting a Neuromodulatory System Relevant to Alzheimer's Disease to Enhance Memory
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Groups and Cohorts
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Group/Cohort Intervention/treatment
Healthy older participants
Healthy older participants receiving both stimulation conditions (experimental and placebo) randomized across scanning sessions.
 Device: Transcutaneous vagus verne stimulation
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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. ]

    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.


  2. Performance on the online memory task - Post-session 2 [ 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.



Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy older individuals participating in the study will be recruited from the community.
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04877782


Contacts
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Contact: Elise Beckers, MSc. +3243662362 ecj.beckers@maastrichtuniversity.nl
Contact: Heidi IL Jacobs, Dr. +31433884090 h.jacobs@maastrichtuniversity.nl

Sponsors and Collaborators
Maastricht University Medical Center
University of Liege
Investigators
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Principal Investigator: Heidi IL Jacobs, Dr. Maastricht University
More Information
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT04877782    
Other Study ID Numbers: NL77066.068.21
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Time Frame: 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.
Access Criteria:

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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht University Medical Center:
Healthy aging
Transcutaneous vagus nerve stimulation
Magnetic resonance imaging
Locus coeruleus
Memory and attention