Addressing addiction and lifestyle changes in stroke recovery
Addiction in the Secondary Prevention of Stroke
This study is testing how substance use affects recovery after a stroke and whether helping patients make lifestyle changes can improve their emotional health and rehabilitation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT06187025 on ClinicalTrials.gov |
What this trial studies
This study focuses on the relationship between substance use disorders and stroke recovery, emphasizing the need for lifestyle modifications to prevent stroke recurrence. It aims to assess the prevalence of substance-related and addiction disorders among stroke patients and their impact on emotional health and rehabilitation outcomes. The study will utilize interventions such as the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) and Ecological Momentary Assessment (EMA) to gather data and support patients in making necessary lifestyle changes. By understanding these dynamics, the study seeks to inform clinical practices and improve post-stroke care.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 who have recently experienced a clinically symptomatic stroke or Transient Ischemic Attack and are returning for follow-up care.
Not a fit: Patients with severe cognitive impairments or other significant neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation strategies and better outcomes for stroke patients with addiction issues.
How similar studies have performed: While the interplay between addiction and stroke recovery is recognized, this study addresses a relatively novel area with limited prior empirical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female * At least 18 years of age and younger than 80 years; * 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; * Returning to the Bordeaux Hospital neurovascular unit for the standard care 3-months post-stroke follow-up visit; * National Institute Health Stroke Scale (NIHSS) \< 15; * modified Rankin scale ≤ 4; * No severe cognitive impairment as defined by the neurologist; * Written informed consent by the patient; * Coverage by the French National Health Insurance. For the feasibility study assessing the acceptability of the eHealth device to optimize stroke secondary prevention, additional inclusion criteria will be the ability to use a smartphone and living in an area with internet coverage. Exclusion Criteria: * Subarachnoid hemorrhage; Dementia syndrome or other neurologic disorder; * Severe aphasia (NIHSS item 9 ≥ 2) and/or Severe visual impairment interfering with the completion of evaluations; * Severely impaired physical and/or mental health that, according to the neurologist, may affect the participant's capacity to participate in the study; * Pregnancy or breastfeeding; * Inability to read French; * Individuals under legal protection or unable to personally express their consent * Participation in another protocol modifying the patient's follow-up status
Where this trial is running
Bordeaux
- CHU de Bordeaux — Bordeaux, France (Recruiting)
Study contacts
- Principal investigator: Igor Sibon — University Hospital, Bordeaux
- Study coordinator: Igor Sibon
- Email: igor.sibon@chu-bordeaux.fr
- Phone: 05 56 79 55 20
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.