Using brain-computer interfaces to improve attention in children with epilepsy
Invasive Brain-Computer Interfaces for Attention
This study is testing whether a special brain-computer interface can help improve attention in children and teens with epilepsy who haven't found relief from their medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 8 Years to 21 Years |
| Sex | All |
| Sponsor | University of Texas at Austin Academic / other |
| Locations | 1 site (Austin, Texas) |
| Trial ID | NCT06940089 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the effectiveness of a brain-computer interface (BCI) therapy in enhancing attention in children and adolescents with drug-refractory epilepsy. Participants, aged 8 to 21, who already have invasive electrodes implanted for epilepsy monitoring, will be divided into two groups: one receiving the BCI therapy and the other receiving a sham treatment. The study will assess improvements in attention symptoms and recovery times from cognitive deficits post-surgery. This innovative approach leverages existing brain activity data to tailor interventions without requiring additional surgical procedures.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 8 to 21 with drug-refractory epilepsy who have iEEG implants.
Not a fit: Patients who have undergone seizure focus removal or have a history of severe neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to significant improvements in attention for children with epilepsy, enhancing their quality of life and cognitive function.
How similar studies have performed: While this approach is novel in its application to invasive electrodes for attention improvement, similar studies using BCIs have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Austin, Texas
- Dell Children's Medical Center — Austin, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Diego Mac-Auliffe, Postdoc — The University of Texas at Austin
- Study coordinator: Jose Millan, Professor
- Email: jose.millan@austin.utexas.edu
- Phone: 512-232-8111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.