N/A
N=1,672
Bridging the Childhood Epilepsy Treatment Gap in Africa
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT04290975 ↗Enrolled (actual)
1,672
Serious AEs
3.5%
Results posted
Feb 2026
Primary outcome: Primary: Percentage Seizure-free for 6 Months, or Longer, Measured at 24 Months After Enrollment — 371; 299 Participants — p=0.11
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Task-shifting epilepsy care to epilepsy-trained community health workers (CHWs) (Other); Enhanced usual care for epilepsy (EUC) (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Seizure-free for 6 Months, or Longer, Measured at 24 Months After Enrollment |
371; 299 | 0.11 |
| SECONDARY 75% or Greater Reduction in Seizure Frequency as Determined by the Blinded Physician at 24 Months Follow-up Visit |
636; 531 | — |
| SECONDARY Seizure Freedom for Six Months or Longer in Response to the First Prescribed Anti-epileptic Drug |
306; 149 | — |
| SECONDARY Diagnostic Accuracy |
846; 826 | — |
| SECONDARY Mortality |
50; 54 | — |
| SECONDARY Number of Children Who Experienced Status Epilepticus |
194; 196 | — |
| SECONDARY Morbidity |
163; 197; 162; 184; 478; 476 | — |
| SECONDARY Number of Children for Whom an EEG Was Ordered |
6; 22 | — |
| SECONDARY Task-shifted Protocol Adherence |
— | — |
| SECONDARY Anytime 6-month Seizure-free Interval |
448; 440 | — |
Summary
About half of the world's children with epilepsy do not receive treatment - known as the epilepsy treatment gap - with significantly higher rates (67%-90%) in low- and middle-income countries (LMICs). We will conduct the first cluster-randomized clinical trial (cRCT) to determine the efficacy, implementation, and cost-effectiveness of a novel intervention shifting childhood epilepsy care to epilepsy-trained community health extension workers in an effort to close the epilepsy treatment gap. This research will provide information to help extend epilepsy treatment to children in LMICs and worldwide who suffer from untreated seizures.
Eligibility Criteria
Inclusion Criteria
- Resident of Kano or Kaduna states and living in the Kano, Zaria, or Kaduna metropolitan areas of northern Nigeria
- Parent or guardian provided informed consent for the screening questionnaire given to the parent/guardian
- Parent or guardian informed consent, plus assent for children >7 years able to provide assent, for epilepsy diagnostic evaluation if the screening for possible epilepsy is positive
- Diagnosed with possible epilepsy through initial screening, and then diagnosed with epilepsy upon further evaluation by an epilepsy-trained CHW working with the BRIDGE project, who may consult a BRIDGE physician for diagnostic questions
- Parent or guardian provided consent, and assent for children >7 years able to provide assent, for enrollment in the cRCT of task-shifted epilepsy care versus enhanced physician epilepsy care
Exclusion Criteria
- Children who have previously been diagnosed with epilepsy and are currently enrolled in other care and treatment, or who have been treated for epilepsy within three months prior to screening
- Children who are currently receiving care by a neurologist or neurosurgeon for a serious brain disorder (e.g., brain tumor, stroke)
- Lack of informed consent, and/or lack of assent from children >7 years who are able to provide assent.Inability of the parent or guardian to communicate with healthcare providers in either Hausa or English
- Any child who screens positive for epilepsy, has epilepsy upon clinical evaluation, but does not live in Kano, Zaria, and Kaduna, and who is in the judgement of the parents and/or BRIDGE staff to be unable to comply with the study visits because of travel distance from home.
Data sourced from ClinicalTrials.gov (NCT04290975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.