Status:
RECRUITING
Invasive Brain-Computer Interfaces for Attention
Lead Sponsor:
University of Texas at Austin
Conditions:
Epilepsy in Children
Epilepsy
Eligibility:
All Genders
8-21 years
Phase:
NA
Brief Summary
The goal of this interventional study is to compare if the use of a brain-machine interface (BCI) therapy can improve the symptoms of attentional deficit by producing brain changes in the networks tha...
Detailed Description
This research differs from others available in that it is among the first of its kind to be performed on participants with invasive electrodes in a hospital setting. Additionally, it focuses on epilep...
Eligibility Criteria
Inclusion
- Children and adolescents (8-21 years)
- Confirmed diagnosis of drug-refractory epilepsy
- iEEG implants on the GK network (ventro-lateral prefrontal cortex and executive network). Also desirable in areas related with attention and Action Phase processing
- Normal to corrected vision
- Ability to understand instructions to follow protocols
- Able to read and understand English or Spanish (all evaluations will be conducted depending on the mother tongue of the participant)
- Able to assent together with his/her legal guardian (below 18 years old) or approve (18 years old or older) informed consent
Exclusion
- Prior history of seizure focus removal
- Prior history of ischemic or hemorrhagic stroke
- Prior history of traumatic brain injury
- Prior history of color blindness
- Intracranial implants
- Headaches disorders
- Neurological infections
- Neurological pain or malnutrition disorders
- Severe mental disorders: depression, anxiety, among other psychiatric diseases
- Severe intellectual and learning disabilities
- Compromised consciousness
- Severe physical impairment (i.e. inability to mobilize upper extremities by oneself)
- Severe co-morbidities (active cancer within 5 years, cardiovascular diseases, severe metabolic diseases, hepatic or kidney failure, recent major surgery, infectious diseases)
- Substance or alcohol abuse
- Pregnancy
- Criteria identified in safety guidelines for MRI, in particular metallic implants. Participants who are unable to perform MRI will be completely excluded from the study
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06940089
Start Date
May 1 2025
End Date
December 1 2026
Last Update
April 23 2025
Active Locations (1)
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1
Dell Children's Medical Center
Austin, Texas, United States, 78723