Cerebellar Stroke and Mood Disorders (NCT03515486) | Clinical Trial Compass
CompletedNot Applicable
Cerebellar Stroke and Mood Disorders
France38 participantsStarted 2017-01-16
Plain-language summary
Post-stroke mood disorders (PSMD), including depression, anxiety and apathy, are observed in about 30 % of stroke patients at follow-up 3 or 4 months after stroke occurrence. They impair the functional outcome of the patients and their quality of life. Among the different brain structures involved in PSMD the role of the cerebellum has been under-evaluated while it is now well-known to be involved in mood regulation. The aim of this study will be to describe the characteristics of early and late mood disorders following a first acute ischemic cerebellar stroke using face to face interviews and mobile technologies and investigate their pathophysiological mechanisms through advanced brain Magnetic resonance imaging (MRI) evaluation of cortico-cerebello-cortical morphological and functional connectivity.
Who can participate
Age range
18 Years – 90 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 :
* Patients with a first ischemic stroke affecting the cerebellum and returning to a post-visit AVS at 4 ± 1 month
* Age \> 18 ans
* Modified Rankin Scale pre-stroke ≤ 1
Exclusion Criteria :
* History of central neurological disorder
* Pre-stroke cognitive impairment (IQ-code\> 3.3) or post-stroke cognitive disorder defined by a MoCA \< 24
* History of mood disorders history in the 6 months prior stroke (clinical screening)
* Moderate to severe leukoencephalopathy (Fazekas score ≥ 2 )
* Unable to use a smartphone (aphasia, visual disorder…)
* Participation in a pharmacological protocol involving psychotropic drugs (anxiolytics, antidepressants, antipsychotics) or a non-pharmacological protocol involving psychotherapeutic management
* Pregnancy
* MRI contra-indication(pacemaker, claustrophobia ...)
* Non affiliated to the French social insurance
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.
What they're measuring
1
Center of Epidemiological Studies-Depression scale (CES-D)