Status:
COMPLETED
Modulating the Locus Coeruleus Function
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
University of Liege
Conditions:
Healthy Aging
Eligibility:
All Genders
60-80 years
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 an...
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 in...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 5 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04877782
Start Date
January 14 2021
End Date
October 5 2023
Last Update
October 23 2023
Active Locations (1)
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1
Maastricht University
Maastricht, Netherlands, 6229 ET