Potential EEG Biomarkers and Antiepileptogenic Strategies for Epilepsy in TSC

Completed

Conditions studied: Tuberous Sclerosis Complex

In brief

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.

Key facts

Study ID

NCT01767779

Run by

University of Alabama at Birmingham

People needed

40

Starts

2012-09-01

Expected to finish

2018-12-01

Last updated by the study team

2019-04-11

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• UCLA — Los Angeles, California, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• University of Texas in Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.