Long-term effects of Ebola on children's brain health
Long-Term Neurologic and Neurocognitive Sequelae Following Pediatric Ebola Virus in Liberia
This study is trying to see how Ebola affects the brain health and thinking skills of children who had the virus when they were under 18.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 410 (estimated) |
| Ages | 7 Years to 30 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Monrovia) |
| Trial ID | NCT06811129 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the long-term neurological and neurocognitive effects of Ebola virus disease (EVD) in individuals who were under 18 years old during their infection. Participants, who were previously enrolled in the PREVAIL III study, will undergo a single clinic visit where they will complete a neurologic exam, neurocognitive assessments, and a symptom questionnaire. The study seeks to better understand the cognitive and neurological challenges faced by pediatric EVD survivors and their close contacts. By gathering this data, researchers hope to shed light on the lasting impacts of EVD on brain health in children.
Who should consider this trial
Good fit: Ideal candidates include individuals who were under 18 years old at the time of their enrollment in the PREVAIL III study, either as EVD survivors or close contacts.
Not a fit: Patients who were not part of the PREVAIL III study or who do not have a history of Ebola virus exposure will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the long-term health needs of pediatric Ebola survivors, leading to improved care and support strategies.
How similar studies have performed: While there have been studies on adult EVD survivors, this specific focus on pediatric populations and their long-term neurological outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Stated willingness to comply with all study procedures and availability for the duration of the study. 2. Male or female, previously enrolled in PREVAIL III Natural History of Ebola study as either an EVD survivor, or a close contact.\* 3. Aged \< 18 Years Old at the time of enrollment in PREVAIL III Natural History of Ebola study. 4. Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document. * Close contacts are those who had a relationship with someone who survived EVD but were never diagnosed with EVD themselves. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. At the time of enrollment, lacks consent capacity due to cognitive impairment that would make them incapable of understanding the explanation of the procedures in this study. Cognitive capacity to consent will be determined at the time of enrollment. Participants with mental disorders or those participants who are cognitively impaired yet still retain consent capacity will not be excluded. 2. Is unable to comply with the procedures of the protocol. 3. Has any condition in the judgement of the study staff that would make the volunteer unable to participate in the study. 4. Is non-English speaking. Justification for the Exclusion of Non-English Speakers We plan to include speakers of simple Liberian English in this study. The tools we use for cognitive testing are not validated in any other language, other than English. It is expected that most, if not all, of the cohort we will be recruiting from will be simple Liberian English speakers.
Where this trial is running
Monrovia
- John F. Kennedy Medical Center — Monrovia, Liberia (Recruiting)
Study contacts
- Principal investigator: Bridgette J Billioux, M.D. — National Institute of Neurological Disorders and Stroke (NINDS)
- Study coordinator: Bridgette J Billioux, M.D.
- Email: bridgette.billioux@nih.gov
- Phone: (301) 412-4452
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.