Clinical trial · Observational
Potential EEG Biomarkers and Antiepileptogenic Strategies for Epilepsy in TSC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine whether EEGs during infancy is a reliable biomarker to identify TSC patients that will develop infantile spasms/epilepsy in the near future and thus are appropriate candidates for an antiepileptogenic drug trial. Since not all patients with TSC develop epilepsy, it would be useful to have a biomarker that could predict those patients destined to have epilepsy and thus identify those TSC patients most appropriate for an antiepileptogenic drug trial. A recent study suggests that treating TSC patients with an abnormal EEG prior to onset of infantile spasms with vigabatrin may improve neurological outcome, but the use of EEG as a reliable biomarker of future epilepsy has not been rigorously validated. In this specific aim, we will test the reliability of EEG in predicting future development of infantile spasms or epilepsy in TSC patients during the first year of life.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tuberous Sclerosis Complex | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- seizure free infants with dx of TSC
- description
- infants that are seizure free at the time of the study enrollment and meets genetic or clinical diagnostic criteria for TSC
- label
- Parents or family guardian of cohort 1
- description
- Parent or family guardian of infants that are seizure free at the time of the study enrollment and meets genetic or clinical diagnostic criteria for TSC.
Primary outcomes (1)
- measure
- Identification of EEG biomarkers as predictors of developing epilepsy in infants with Tuberous Sclerosis Complex
- timeFrame
- 3 years
- description
- Physical/neurological exam, Video EEG, Developmental assessments, Blood draw from child and parents/guardian, and Seizure diaries.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 6 Months
Show eligibility criteria text
Inclusion Criteria: Cohort 1 * \< 6 months of age; Seizure free at the time of study enrollment; and meets genetic or clinical diagnostic criteria for TSC (Tuberous Sclerosis), the latter based on current recommendations for diagnostic evaluation, such as physical exam, neuroimaging, echocardiogram. Cohort 2 * Parent or family guardian of infant Exclusion Criteria: Cohort 1 * ≥ 6months of age; history of seizures and/or infantile spasms; patients receiving vigabatrin or any anti-epileptic medication or mTOR inhibitor prior to study enrollment Cohort 2 * not parent or family guardian
References
Publications (1)
- DERIVEDSadeghzadeh S, Johnstone TM, Peters JM, Porter BE, Ihnen SKZ. Association of earlier surgery with improved postoperative language development in children with tuberous sclerosis complex. J Neurosurg Pediatr. 2024 Jul 12;34(4):384-392. doi: 10.3171/2024.4.PEDS2481. Print 2024 Oct 1. PMID 38996393