Electrophysiological Biomarkers of GABA Metabolism in Children With SCN1A+ Dravet Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

This study will non-invasively obtain levels of GABA in the brain of children with SCN1A+DS and neurodeveloping children through evoked and induced cortical responses, correlate them with the BOLD responses, and with the levels of GABA in their blood.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: t
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• Authorized representative (parent/caregiver) must be willing and able to give informed consent for the participant's participation in the study. Participants capable of providing informed assent must be willing to provide their assent.

• Participant and their parent/caregiver are willing and able (in the PI's opinion) to comply with all study requirements.

• Participant is male or female aged between 0 months and 18 years of age, inclusive, at the time of consent.

• Participant has a confirmed pathogenic or likely pathogenic SCN1A mutation, as demonstrated by genetic testing.

• Participant had normal development prior to onset of first seizure as defined by the Centers for Disease Control and Prevention (CDC 2019).

• Participant had an onset of seizures, defined as first focal clonic/hemiclonic, generalized/focal, generalized tonic-clonic/clonic, atonic, prolonged seizure, or status epilepticus between age 3 and 5 months, inclusive.

• Participant should have an evaluation by a pediatric neurologist with a diagnosis of DS.

Locations
United States
Texas
Cook Children's Medical Center
RECRUITING
Fort Worth
Contact Information
Primary
Sabrina Shandley, PhD
Sabrina.Shandley@cookchildrens.org
(682) 885-3437
Time Frame
Start Date: 2022-09-08
Estimated Completion Date: 2027-09-08
Participants
Target number of participants: 36
Treatments
Dravet
Age-Matched Control
Sponsors
Leads: Cook Children's Health Care System
Collaborators: Encoded Therapeutics

This content was sourced from clinicaltrials.gov