NCT04043052Completed
Mobile Technologies and Post-stroke Depression
MObile Technologies In the preVention of POSt-stroke DEPression
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
The recent development of acute phase treatments has dramatically improved stroke functional outcome but post-stroke neuropsychiatric disorders, notably post-stroke depression, continue to contribute to the heavy burden of stroke. While these conditions affect about 25% of stroke patients at 3 months, they are under-reported spontaneously by patients and are under-evaluated and treated by clinicians. Other than stroke severity and psychiatric history, risk factors for post-stroke depression remain a matter of debate, thus preventing identification of high-risk patients. Moreover, to date, neither pharmacological nor nonpharmacological treatments have demonstrated a significant benefit in the prevention of this disorder, thereby also impeding the development of early treatment strategies. Yet,the early management of post-stroke depression is critical given its negative influence on long-term functional outcomes, medication adherence, efficient use of rehabilitation services and the risk of stroke recurrence or vascular events. There is a pressing need to develop new tools allowing for the early detection of post-stroke neuropsychiatric complications for each individual patient. The rapid expansion of ambulatory monitoring techniques, such as Ecological Momentary Assessment (EMA), allows daily evaluations of mood symptoms in real time and in the natural contexts of daily life. The investigators have previously validated the feasibility and validity of EMA to assess daily life emotional symptoms after stroke, demonstrating its utility to investigate their evolution during the 3 months following stroke and to identify early predictors of post-stroke depression such as stress reactivity and social support, suggesting that EMA could be used in the early personalized care management of these neuropsychiatric complications. Recently, preliminary data have also emphasized the potential of EMA interventions to improve the outcome of psychiatric disorders.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 401 (actual)
- First submitted
- 25 Jul 2019
- Start date
- 9 Sept 2020
- Primary completion date
- 26 Sept 2024
- Lead sponsor
- University Hospital, Bordeaux
- Diseases
- Stroke
- NCT number
- NCT04043052
What you commit to
- Study type: Interventional
- Participants enrolled: 401
- From 9 Sept 2020 to the primary completion date, 26 Sept 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subarachnoid hemorrhage.
- Dementia syndrome or other neurologic disorder and/or severe aphasia (NIHSS item 9 ≥ 2) interfering with the completion of evaluations and the utilization of EMA.
- Severe visual impairment interfering with the utilization of EMA.
- Patients with a severe substance use disorder (DSM-5 criteria)
Other
- Transient Non Cerebrovascular Event.
- Severely impaired physical and/or mental health that, according to the investigator, may affect the participant's compliance with the study
- Patients under antidepressant and/or anxiolytic and/or neuroleptic and/or mood stabilizer treatment during the month preceding inclusion
- Participation in another protocol modifying the patient's follow-up status.
- Pregnancy or breastfeeding
- Inability to read French or to use a smartphone
- Individuals under legal protection or unable to express personnally their consent
- Individuals living in an area without 3G/4G internet coverage
Who the study is looking for
- Age ≥ 18 years.
- Male or Female.
- Recent (≤ 15 days) clinically-symptomatic ischemic or hemorrhagic stroke documented through brain imaging (CT or MRI) or a Transient Ischemic Attack with an ABCD2 score ≥ 4.
- Patient discharged to home after hospitalization in the stroke unit.
- No severe neurological handicap: modified Rankin scale ≤ 3 at inclusion.
- No severe cognitive impairment or dementia: MoCA ≥ 16 at inclusion.
- Written informed consent by the patient.
- Covered by French Social Insurance
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| CHRU de Brest Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| Chu Dijon Bourgogne Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| CHU de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Assistance Publique Hopitaux de Paris - Groupe Hospitalier Paris Saint Joseph Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.