Invasive Brain-Computer Interfaces for Attention

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 that modulate attention. The investigators intend to work with epileptic participants who do not respond to pharmacological treatment, who will undergo neurosurgery. The questions the study sets out to answer are: 1. is there an improvement of symptoms in an experimental group receiving the treatment versus a sham group receiving a simulation of the treatment? 2. does the application of the therapy before surgery reduce the recovery times of post-surgery cognitive deficits described in the literature? Making use of the information recorded from brain electrodes implanted before a participant's epilepsy surgery, the investigators will create a BCI decoder that works with the available activity sources to establish the level of attention of each participant when performing tasks. Participants: * will perform an offline phase first, which will consist of one day of evaluation, in which they will be familiarized with an attentional task. * will perform a training phase later, which will consist of several days of evaluation, where they will learn to modulate their level of attention. This modulation will be facilitated by the BCI decoder, which will classify the level of attention directly from the brain and provide visual feedback that the participant will use as a guide. If the participant is part of the experimental group (or BCI group), the feedback will work as described and should be easy to follow, but if the participant is part of the Sham group, the feedback will not work according to the brain activity of the actual participant, but according to that of another person. Because of this, a mismatch will be created between the moments a brain experiences inattention, and participants believe they are experiencing inattention. This is a randomized, double-blind study, in which the experimenters will evaluate how the effect of the attentional therapy with BCI affects an BCI group and a Sham group.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
Dell Children's Medical Center
RECRUITING
Austin
Contact Information
Primary
Jose Millan, Professor
jose.millan@austin.utexas.edu
512-232-8111
Backup
Liberty Hamilton, Professor
liberty.hamilton@austin.utexas.edu
512-471-1929
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 30
Treatments
Experimental: This arm will receive visual feedback controlled by its own BCI
Sham_comparator: This arm will receive visual feedback from another randomly selected participant
Related Therapeutic Areas
Sponsors
Leads: University of Texas at Austin

This content was sourced from clinicaltrials.gov