Investigation of Locus Coeruleus Function in Sustained Attention (NCT06041048) | Clinical Trial Compass
RecruitingPhase 4
Investigation of Locus Coeruleus Function in Sustained Attention
United States40 participantsStarted 2023-10-01
Plain-language summary
The norepinephrine-producing locus coeruleus (LC) is thought to be central to a wide array of cognitive functions, like attention and goal pursuit, and has been implicated in dysfunctions including attention deficit hyperactivity disorder and schizophrenia. The goal of this proposal is to develop methods that permit measurement of activity in the human LC. Because the LC is small and located in the pons, the Investigators will use high resolution magnetic resonance imaging techniques tailored to the brainstem environment, including neuromelanin-sensitive images shown to delineate the LC, combined with pharmacological manipulation to confirm the location of functional activity.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Between the ages of 18 - 60 years of age,
* Typically developing, healthy adult
Exclusion Criteria:
* History of schizophrenia, other forms of psychosis,
* Specific or focal neurological disorder or severe alcohol or drug use disorder within the past 5 years
* History of left ventricular hypertrophy or in patients with mitral valve prolapse who have experienced the mitral valve prolapse syndrome when previously receiving CNS stimulants, or who have had recent history of myocardial infarction or unstable angina.
* Volunteers with known hypersensitivity to modafinil or armodafinil or its inactive ingredients
* Known allergy/sensitivity or any hypersensitivity to components of modafinil or its formulation
* Inability to swallow tablets or tolerate oral medication;
* Pregnant or nursing (participants will be required to have a negative pregnancy test)
* Contraindication for MRI scanning (metal implants, pacemakers, metal foreign bodies, or pregnancy)
* Use of psychotropic medication within the past week
* Claustrophobic and not comfortable being in a small space may also not want to participate
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.