An interventional study of Attention Intervention using a customized BCI decoder and Attention Intervention without using a customized BCI decoder in Epilepsy in Children and Epilepsy, sponsored by University of Texas at Austin. Withdrawn at 1 site in United States. Open to participants aged 8 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University of Texas at Austin · Not applicable, Interventional, and Treatment
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:
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:
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.
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 epileptic participants, who already have a set of invasive electrodes in place, so there is no need for any additional surgical intervention.
Also, the age range of participants for the study (between 8 and 21 years old) usually presents a high incidence of attentional disorders, so it is considered a good group to carry out this research.
This research does not require any additional intervention of any kind, except for the participant willingness to participate, with the possibility of improving their baseline attentional level, or at least of recovering their baseline attentional level faster after surgery, which usually decreases it.
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Exclusion Criteria:
Behavioral: Attention Intervention using a customized BCI decoder
Behavioral: Attention Intervention without using a customized BCI decoder
During the offline phase of the intervention, participants will perform an attentional task while intracranial brain activity is recorded. Data from this session will be used to train a personalized decoder capable of classifying attentional engagement. During the training phase, participants will receive real-time visual feedback contingent on their brain activity when attentional engagement is detected. This closed-loop feedback aims to reinforce successful attention and enhance performance over repeated sessions.
During the offline phase, participants will perform an attentional task while intracranial brain activity is recorded. A personalized decoder will be created for each participant but will not be used during the training phase sessions. During the training phase, participants will receive visual feedback while performing attentional tasks; however, the feedback will not be contingent on their brain activity. Instead, feedback will be non-contingent and unrelated to actual attentional engagement. This group is not expected to experience improvements in attentional performance through the training sessions.
Sustained attention as assessed by Conners Continuous Performance Test, 3rd Edition
The CPT-3 is a task-oriented computerized assessment used to evaluate attention-related problems in individuals aged 8 years and older. The test provides objective information about an individual's performance in attention tasks. T-scores: \~30 (Min) / 100+ (Max); higher score = worse performance; Confidence Index: 0 (Min) / 1.00 (Max); higher score = worse performance (closer to 1 = more likely atypical)
Time frame: Perioperative/periprocedural, and 3 months after hospital discharge
Working memory as assessed by WISC-IV/WISC-V or WAIS-III/WAIS-IV
The WISC is a standardized test used to assess the intellectual ability of children aged 6 to 16 years. It evaluates multiple cognitive domains, including verbal comprehension, visual-spatial reasoning, working memory, processing speed, and fluid reasoning (added in WISC-V). The WAIS is the adult counterpart to the WISC and is used to assess the intelligence of individuals aged 16 to 90 years. Like the WISC, it evaluates cognitive abilities across domains such as verbal comprehension, perceptual reasoning, working memory, and processing speed. Full Scale IQ \& Index Scores: 40 (Min) / 160+ (Max); higher score = better cognitive ability; Subtest Scaled Scores: 1 (Min) / 19 (Max); higher score = better performance on that subtest
Time frame: Perioperative/periprocedural, and 3 months after hospital discharge
Executive function as assessed by Verbal Fluency and Trail Making, of the Delis-Kaplan Executive Function System
The D-KEFS Verbal Fluency evaluates an individual's verbal productivity, cognitive flexibility, and executive control over language. It includes Letter Fluency, Category Fluency, and Category Switching. The D-KEFS Trail Making assesses visual attention, psychomotor speed, sequencing, cognitive flexibility, and set-shifting. The Trail Making subtest is useful for detecting executive dysfunction and is frequently used in evaluating individuals with brain injuries, neurodevelopmental disorders, and neurodegenerative conditions. Verbal Fluency, Scaled Score: 1 (Min) / 19 (Max); higher score = better performance; Verbal Fluency, Error Rates 0 - ∞ (raw count); higher score = worse performance; Trail Making, Scaled Score: 1 (Min) / 19 (Max); higher score = better performance; Trail Making, Error Rates 0 - ∞ (raw count); higher score = worse performance
Time frame: Perioperative/periprocedural, and 3 months after hospital discharge
Executive function as assessed by Behavior Rating Inventory of Executive Function, 2nd edition
The BRIEF-2 is a standardized questionnaire-based assessment designed to evaluate executive function behaviors in everyday settings. It is typically completed by parents, teachers, or the individual (self-report) and is used for children and adolescents aged 5 to 18 years. It assesses multiple domains of executive functioning-such as inhibition, working memory, emotional control, task initiation, and cognitive flexibility-and provides composite scores like the Behavioral Regulation Index, Emotion Regulation Index, and Cognitive Regulation Index. T-scores (Scales \& Indexes): 30 (Min) / 100+ (Max); higher score = worse executive functioning; Global Executive Composite (GEC): 30 (Min) / 100+ (Max); higher score = worse executive functioning
Time frame: Perioperative/periprocedural, and 3 months after hospital discharge
Subjective Attention Self-Report Visual Analog Scale (SASR-VAS)
The SASR-VAS is a brief, self-administered tool to assess how the participant experiences attentional problems and whether they have noticed any changes over time. The scale consists of single-item visual analog ratings, scored on a 0 to 10 Visual Analog Scale (VAS). Scores: 0 (Min) / 10 (Max); higher score = better perceived attentional functioning and greater perceived improvement
Time frame: Perioperative/periprocedural, and 3 months after hospital discharge
Markers of plasticity as assessed by Functional MRI
Participants will undergo two fMRI sessions to assess changes in brain activity patterns associated with neuroplasticity. Each session will be conducted before and after the whole intervention. fMRI session will be divided into two parts: an initial resting phase, and an intervention phase (where participants will perform the same tasks as during the intervention/online sessions). By measuring blood-oxygen-level-dependent (BOLD) signals during rest and/or task performance, fMRI can identify percent (%) signal changes in specific Regions of Interest (ROI) over time.
Time frame: Perioperative/periprocedural
Change on activity as assessed by iEEG Recordings: Attentive
The investigators can measure changes in participants' brain activity to understand how the brain responds to training. The target activity consists of the increase in amplitude (µV) or power (µV²/dB) in the high-gamma frequency \[50-150\] Hz in Regions of Interest (ROI) around the dorsolateral prefrontal (dlPFC) and ventrolateral prefrontal (vlPFC) cortices during attention trials.
Time frame: Perioperative/periprocedural
Change on activity as assessed by iEEG Recordings: Resting
The investigators can measure changes in participants' brain activity to understand how the brain responds to training. The target activity consists of the decrease or lack in amplitude (µV) or power (µV²/dB) in the high-gamma frequency \[50-150\] Hz in Regions of Interest (ROI) around the dorsolateral prefrontal (dlPFC) and ventrolateral prefrontal (vlPFC) cortices during rest trials.
Time frame: Perioperative/periprocedural
BCI Performance: Accuracy
The investigators can calculate different contingency metrics, based on how well each participant's decoder (either from the BCI or Sham group) interprets their attentional intent or mental state. All metrics are extracted from confusion matrices. Between the most relevant, Accuracy: 0 (Min) / 1 (Max); lower score = model makes all predictions incorrectly, higher score = model makes all predictions correctly
Time frame: Perioperative/periprocedural
BCI Performance: Sensitivity
The investigators can calculate different contingency metrics, based on how well each participant's decoder (either from the BCI or Sham group) interprets their attentional intent or mental state. All metrics are extracted from confusion matrices. Between the most relevant, Sensitivity: 0 (Min) / 1 (Max); lower score = model misses all actual positives (only false negatives), higher score = model detects all actual positives (no false negatives)
Time frame: Perioperative/periprocedural
BCI Performance: Specificity
The investigators can calculate different contingency metrics, based on how well each participant's decoder (either from the BCI or Sham group) interprets their attentional intent or mental state. All metrics are extracted from confusion matrices. Between the most relevant, Specificity: 0 (Min) / 1 (Max); lower score = model misses all actual negatives (only false positives), higher score = model correctly identifies all negatives (no false positives)
Time frame: Perioperative/periprocedural
BCI Performance: Precision
The investigators can calculate different contingency metrics, based on how well each participant's decoder (either from the BCI or Sham group) interprets their attentional intent or mental state. All metrics are extracted from confusion matrices. Between the most relevant, Precision: 0 (Min) / 1 (Max); lower score = all predicted positives are wrong (only false positives), higher score = all predicted positives are correct (no false positives)
Time frame: Perioperative/periprocedural
BCI Performance: F1 Score
The investigators can calculate different contingency metrics, based on how well each participant's decoder (either from the BCI or Sham group) interprets their attentional intent or mental state. All metrics are extracted from confusion matrices. Between the most relevant, F1 Score: 0 (Min) / 1 (Max); lower score = no balance between precision and sensitivity (either is 0), higher score = perfect balance of precision and sensitivity (both = 1)
Time frame: Perioperative/periprocedural
BCI Performance: Matthews Correlation Coefficient (MCC)
The investigators can calculate different contingency metrics, based on how well each participant's decoder (either from the BCI or Sham group) interprets their attentional intent or mental state. All metrics are extracted from confusion matrices. Between the most relevant, Matthews Correlation Coefficient (MCC): -1 (Min) / 0 (Chance Level) / +1 (Max); lower score = perfect inverse prediction of the model, higher score = perfect prediction of the model
Time frame: Perioperative/periprocedural
Experiment Performance: Correct Trials per Session
Correct Trials per Session will be assessed according to the number of correct answers per run and session. There will be multiple trials within a run, and several runs within a session. Session data will be used to evaluate: within-subject changes over time (e.g., session-to-session improvements), using dependent comparisons; and between-group differences, particularly comparing participants in the BCI intervention group and the Sham control group, using independent comparisons. Number of trials per run: 0 (Min) / 20 (Max); higher score = greater engagement or attentional control within a run Number of runs per session: \~ 4 (Min) / 8+ (Max); higher score = greater engagement or attentional control within a session Number of sessions per participant: \~ 3 (Min) / 7+ (Max); higher score = greater engagement or attentional control between sessions
Time frame: Perioperative/periprocedural
Plan to share: Yes — All anonymized data will be made available upon request by the online publication date
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University of Texas at Austin