Brain scans aim to unlock the mystery of Post-Stroke apathy
NCT ID NCT03998852
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study uses PET and MRI brain scans to compare the activity of two key brain chemicals—dopamine and acetylcholine—in 30 people who have had a stroke, half with apathy and half without. The goal is to better understand what causes apathy after a stroke, which could eventually help doctors choose more effective treatments. Participants will undergo imaging and neuropsychological tests, but no new therapy is being tested.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PET radiotracers ([18F]-FDOPA and [18F]-FEOBV) and MRI
- What this could lead to
- If successful, this could point toward better, more targeted treatments for apathy after stroke.
- What could go wrong
- This is a small, early-phase imaging study (30 participants) that does not test any treatment. It may not lead to direct patient benefits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2021
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient of legal age and younger than 75 years * Patient with a Rankin score less then or equal to 2 and with or without apathy, demonstrated by AI scales at 3 months after stroke (apathetic patient = AI scale score \> 2) * Affiliate or beneficiary of a social security scheme * Subjects (female study subjects and female partners of male participants) using highly effective contraceptive methods (intra-uterine device, progestin or estrogen-progestin contraceptive, sterilization) * Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research) Exclusion Criteria: * Patients over 75 years old * Taking of any pharmacological treatment likely to affect cholinergic systems at the time of PET-scan: Amitriptyline, Atropine, Brompheniramine, Chlorphenamine, Chlorpromazine, Clomipramine, Clozapine, Dimenhydrinate, Diphenhydramine, Doxepine, Hyoscyamine, Imipramine, Meclozine, Nortriptyline, Oxybutynine, Promethazine, Scopolamine, Trimipramine, Hydroxyzine. * Taking of any pharmacological treatment likely to affect dopaminergic systems at the time of PET-scan: glucagon, haloperidol, reserpin * Taking of any selective serotonine reuptake inhibitors treatment * White matter T2 hyperintense lesions (Fazekas score \> 3) * NYHA Class III to IV Heart Failure Patient * Patients with allergy or conter-indication to entacapone * Subjects with positive pregnancy test (BHCG dosage and Urine dipstick), and/or currently breast-feeding * Patients unable to come back to hospital for at least 2-follow-up visits * Patient with a chronic neurological disorder or severe psychiatric disorder * Patient with cognitive impairment (MoCA\<24) and depression (CES-D score \> 17 for men and \>23 for women) * Patient presenting a counter-indication for MRI * Patient presenting a counter-indication for TEP with \[18F\]-FEOBV or \[18F\]-FDOPA (known allergy) * Patient who underwent a PET examination in the previous month * Patient with state of health not allowing a displacement in the department of imaging of the CHU: bedridden state, state of health very deteriorated * Patient deprived of liberty by judicial or administrative decision * Patient under legal protection or unable to express its own consent * Subject within exclusion period from another clinical trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Bordeaux University Hospital
RECRUITINGBordeaux, 33076, France
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Other studies related to the condition(s) this trial covers.
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- Study links apathy to different fatigue types in seniors