Long-Term Neurologic and Neurocognitive Sequelae Following Pediatric Ebola Virus in Liberia

NCT06811129 | Completed

• 2 other identifiers: 10001809001809-N
• Study Type: observational
• Target: 328
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Ebola virus disease (EVD) causes fever, vomiting, and diarrhea, and may cause internal bleeding. It is often fatal. EVD may also damage the brain and nervous system. It can cause headaches, tremors, weakness, and other problems. These issues can continue for years after people recover from EVD infection. Researchers want to understand more about how EVD may have affected the brains of people who contracted the disease as children. Objective: To learn more about the long-term effects of EVD on the brain and nervous system in people who had the disease as children. Eligibility: People who were less than 18 years old when they took part in a previous study called the PREVAIL III Natural History of Ebola study. They can be either a survivor of EVD or a close contact. A close contact is someone who had a relationship with a person who survived EVD but never had the disease themself. Design: Participants will have 1 clinic visit. They will undergo several tasks: They will have an exam of their nervous system performed by a neurologist. They will do physical tasks and answer questions about any problems or symptoms since they had EVD. They may have blood drawn. They will have tests of their memory, attention, and thinking skills. For one test, participants will answer questions and solve puzzles using pencil and paper. For another test, they will play 4 different games on an iPad. They will have an interview. A researcher will ask questions about their mood and other symptoms that may affect their brain and nervous system; their past medical diagnoses, symptoms, and experiences; and how they are doing at home, school, or work.

Conditions

Ebola; Post-Acute Ebola Syndrome

Keywords

Ebola; Neurologic; Pediatric; Post-Acute Ebola Syndrome; Cognitive; Global Neurology

Outcome Measures

Primary Outcomes (2)

• Pediatric EVD Neuro Follow up Study

  To observe and describe the range of neurologic and neurocognitive findings that are present in EVD survivors at greater than 5 years following infection as compared to controls. In comparison of EVD survivors at greater than 5 years following infection with close contacts, the prevalence of:- neurological symptoms (as asked on neurologic symptom questionnaire CRF) - physical disability (as assessed through MRS score) - executive function dysfunction (as assessed through executive function assessment questions) - neuropsychiatric symptoms (as indicated on neuropsychiatric symptom portion of CRF) - neurologic exam abnormalities (as found on full neurologic physical exam performed by licensed neurologist during visit) - neurocognitive deficits (as determined by cognitive exam scores on NIH Toolbox exam and ICA-P assessment)

  5-10 years post-infection

• Longitudinal Pediatric Neuro EVD Sub study (Subset of population)

  To compare neurologic and neurocognitive findings found in EVD survivors and controls at greater than 5 years following infection to that of the same participants at first visit about 1 year post infection.- number of neurological symptoms (as asked on neurologic symptom questionnaire CRF) - Physical disability (as assessed through MRS score) - Executive function dysfunction (as assessed through executive function assessment questions).- number of neuropsychiatric symptoms (as indicated on neuropsychiatric symptom portion of CRF.- persistence of neurologic exam abnormalities (as found on full neurologic physical exam performed by licensed neurologist during visit).- neurocognitive deficits (as determined by cognitive exam scores on NIH Toolbox exam and ICA-P assessment).

  5-10 years post-infection

Secondary Outcomes (2)

• Longitudinal Pediatric Neuro EVD Sub study:

  5-10 years post-infection

• Pediatric EVD Neuro Follow up Study

  5-10 years post-infection

Study Arms (2)

Close Contacts

Male of female, previously enrolled in PREVAIL III Natural History of Ebola study as a close contact. Close contacts are those who had a relationship with someone who survived EVD but were never diagnosed with EVD themselves.

EVD Survivors

Male or female, previously enrolled in PREVAIL III Natural History of Ebola study as an EVD survivor.

Eligibility Criteria

• Age: 7 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study will include participants of the PREVAIL III Natural History of Ebola Study who were of pediatric age at the time of enrollment, including EVD survivors and close contacts.

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, previously enrolled in PREVAIL III Natural History of Ebola study as either an EVD survivor, or a close contact.\*
• Aged \< 18 Years Old at the time of enrollment in PREVAIL III Natural History of Ebola study.
• 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.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• 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.
• Is unable to comply with the procedures of the protocol.
• Has any condition in the judgement of the study staff that would make the volunteer unable to participate in the study.
• Is non-English speaking.
• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

John F. Kennedy Medical Center

Monrovia, Liberia

Location

Related Publications (10)

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• Jacobs M, Rodger A, Bell DJ, Bhagani S, Cropley I, Filipe A, Gifford RJ, Hopkins S, Hughes J, Jabeen F, Johannessen I, Karageorgopoulos D, Lackenby A, Lester R, Liu RS, MacConnachie A, Mahungu T, Martin D, Marshall N, Mepham S, Orton R, Palmarini M, Patel M, Perry C, Peters SE, Porter D, Ritchie D, Ritchie ND, Seaton RA, Sreenu VB, Templeton K, Warren S, Wilkie GS, Zambon M, Gopal R, Thomson EC. Late Ebola virus relapse causing meningoencephalitis: a case report. Lancet. 2016 Jul 30;388(10043):498-503. doi: 10.1016/S0140-6736(16)30386-5. Epub 2016 May 18.

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• Fallah MP, Reilly C, Van Ryn C, Badio M, Camanor SW, Kaler SG, Johnson B, Orone R, Flumo H, Moses SJ, Johnson KL, Gorpudolo N, Gayedyu-Dennis D, Dighero-Kemp B, Fayiah J, Marron L, Hensley LE, Taylor RJ, Higgs ES, Lane HC, Neaton JD, Sneller MC. Pregnancy, pregnancy outcomes, and infant growth and development after recovery from Ebola virus disease in Liberia: an observational cohort study. Lancet Glob Health. 2023 Jul;11(7):e1053-e1060. doi: 10.1016/S2214-109X(23)00210-3.

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  PMID: 32595045 BACKGROUND

• PREVAIL III Study Group; Sneller MC, Reilly C, Badio M, Bishop RJ, Eghrari AO, Moses SJ, Johnson KL, Gayedyu-Dennis D, Hensley LE, Higgs ES, Nath A, Tuznik K, Varughese J, Jensen KS, Dighero-Kemp B, Neaton JD, Lane HC, Fallah MP. A Longitudinal Study of Ebola Sequelae in Liberia. N Engl J Med. 2019 Mar 7;380(10):924-934. doi: 10.1056/NEJMoa1805435.

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MeSH Terms

Conditions

Hemorrhagic Fever, Ebola; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bridgette J Billioux, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 6, 2025
• Study Start: February 14, 2025
• Primary Completion: September 9, 2025
• Study Completion: September 9, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-03-16

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)