Epilepsy in ChildrenNCT06940089
Invasive Brain-Computer Interfaces for Attention
A study testing Attention Intervention using a customized BCI decoder and Attention Intervention without using a customized BCI decoder in people with Epilepsy in Children and Epilepsy, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Epilepsy in Children, Epilepsy
- What is being tested?
- Attention Intervention using a customized BCI decoder and Attention Intervention without using a customized BCI decoder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
- is there an improvement of symptoms in an experimental group receiving the treatment versus a sham group receiving a simulation of the treatment?
- does the application of the therapy before surgery reduce the recovery times of post-surgery cognitive deficits described in the literature?
Read more
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.
Read the 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 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.
- Conditions
- Epilepsy in Children, Epilepsy
- Being tested
- Attention Intervention using a customized BCI decoder, Attention Intervention without using a customized BCI decoder
- Keywords
- BCI, Brain Computer Interface, Brain-Computer Interface, Attention, Attention deficit, Epilepsy
- Medical subject headings
- Epilepsy, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention Intervention using a customized BCI decoderBehavioural
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.
Attention Intervention without using a customized BCI decoderBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| This arm will receive visual feedback controlled by its own BCI | Experimental | Not described Receives: Behavioral: Attention Intervention using a customized BCI decoder |
| This arm will receive visual feedback from another randomly selected participant | Sham comparator | Not described Receives: Behavioral: Attention Intervention without using a customized BCI decoder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Perioperative/periprocedural
Secondary outcomes (7)
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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: Perioperative/periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Why it stopped: We could not recruit participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Epilepsy in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study has two groups (BCI and Sham) running in parallel without crossover. The first arm receives the active BCI intervention using the IDE device, while the second arm also use the IDE device but receive a sham condition (not the active BCI intervention).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose del R. Millan, University of Texas at Austin
- Investigators
- Diego Mac-Auliffe, Postdoc, Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940089
- Sponsor's protocol ID
- STUDY00003744
- Status last verified
- Apr 2026
- First submitted
- 19 Mar 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All anonymized data will be made available upon request by the online publication date
Publications
Ossandon T, Vidal JR, Ciumas C, Jerbi K, Hamame CM, Dalal SS, Bertrand O, Minotti L, Kahane P, Lachaux JP. Efficient "pop-out" visual search elicits sustained broadband gamma activity in the dorsal attention network. J Neurosci. 2012 Mar 7;32(10):3414-21. doi: 10.1523/JNEUROSCI.6048-11.2012.
PubMed 22399764Ezzyat Y, Wanda PA, Levy DF, Kadel A, Aka A, Pedisich I, Sperling MR, Sharan AD, Lega BC, Burks A, Gross RE, Inman CS, Jobst BC, Gorenstein MA, Davis KA, Worrell GA, Kucewicz MT, Stein JM, Gorniak R, Das SR, Rizzuto DS, Kahana MJ. Closed-loop stimulation of temporal cortex rescues functional networks and improves memory. Nat Commun. 2018 Feb 6;9(1):365. doi: 10.1038/s41467-017-02753-0.
PubMed 29410414Reilly C, Atkinson P, Das KB, Chin RF, Aylett SE, Burch V, Gillberg C, Scott RC, Neville BG. Neurobehavioral comorbidities in children with active epilepsy: a population-based study. Pediatrics. 2014 Jun;133(6):e1586-93. doi: 10.1542/peds.2013-3787.
PubMed 24864167Perrone-Bertolotti M, El Bouzaidi Tiali S, Vidal JR, Petton M, Croize AC, Deman P, Rheims S, Minotti L, Bhattacharjee M, Baciu M, Kahane P, Lachaux JP. A real-time marker of object-based attention in the human brain. A possible component of a "gate-keeping mechanism" performing late attentional selection in the Ventro-Lateral Prefrontal Cortex. Neuroimage. 2020 Apr 15;210:116574. doi: 10.1016/j.neuroimage.2020.116574. Epub 2020 Jan 23.
PubMed 31981780Mac-Auliffe D, Chatard B, Petton M, Croize AC, Sipp F, Bontemps B, Gannerie A, Bertrand O, Rheims S, Kahane P, Lachaux JP. The Dual-Task Cost Is Due to Neural Interferences Disrupting the Optimal Spatio-Temporal Dynamics of the Competing Tasks. Front Behav Neurosci. 2021 Aug 19;15:640178. doi: 10.3389/fnbeh.2021.640178. eCollection 2021.
PubMed 34489652
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Brain-Computer Interfaces for Attention
- ClinicalTrials.gov ID
- NCT06940089
- Acronym / sponsor ID
- STUDY00003744
- Conditions
- Epilepsy in Children, Epilepsy
- Keywords
- BCI, Brain Computer Interface, Brain-Computer Interface, Attention, Attention deficit, Epilepsy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We could not recruit participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- is there an improvement of symptoms in an experimental group receiving the treatment versus a sham group receiving a simulation of the treatment?
- 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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The study has two groups (BCI and Sham) running in parallel without crossover. The first arm receives the active BCI intervention using the IDE device, while the second arm also use the IDE device but receive a sham condition (not the active BCI intervention).
| Arm | Type | Receives |
|---|---|---|
| This arm will receive visual feedback controlled by its own BCI | Experimental | Behavioral: Attention Intervention using a customized BCI decoder |
| This arm will receive visual feedback from another randomly selected participant | Sham comparator | Behavioral: Attention Intervention without using a customized BCI decoder |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attention Intervention using a customized BCI decoderDuring 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. | Behavioural | This arm will receive visual feedback controlled by its own BCI |
| Attention Intervention without using a customized BCI decoderDuring 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. | Behavioural | This arm will receive visual feedback from another randomly selected participant |
Primary outcome
Sustained attention as assessed by Conners Continuous Performance Test, 3rd Edition
Time frame: Perioperative/periprocedural, and 3 months after hospital discharge
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)
Working memory as assessed by WISC-IV/WISC-V or WAIS-III/WAIS-IV
Time frame: Perioperative/periprocedural, and 3 months after hospital discharge
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
Executive function as assessed by Verbal Fluency and Trail Making, of the Delis-Kaplan Executive Function System
Time frame: Perioperative/periprocedural, and 3 months after hospital discharge
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
Executive function as assessed by Behavior Rating Inventory of Executive Function, 2nd edition
Time frame: Perioperative/periprocedural, and 3 months after hospital discharge
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
Subjective Attention Self-Report Visual Analog Scale (SASR-VAS)
Time frame: Perioperative/periprocedural, and 3 months after hospital discharge
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
Markers of plasticity as assessed by Functional MRI
Time frame: Perioperative/periprocedural
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.
Change on activity as assessed by iEEG Recordings: Attentive
Time frame: Perioperative/periprocedural
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.
Change on activity as assessed by iEEG Recordings: Resting
Time frame: Perioperative/periprocedural
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.
7 secondary outcomes
BCI Performance: Accuracy
Time frame: Perioperative/periprocedural
BCI Performance: Sensitivity
Time frame: Perioperative/periprocedural
BCI Performance: Specificity
Time frame: Perioperative/periprocedural
BCI Performance: Precision
Time frame: Perioperative/periprocedural
BCI Performance: F1 Score
Time frame: Perioperative/periprocedural
BCI Performance: Matthews Correlation Coefficient (MCC)
Time frame: Perioperative/periprocedural
Experiment Performance: Correct Trials per Session
Time frame: Perioperative/periprocedural
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 22399764Ossandon T, Vidal JR, Ciumas C, Jerbi K, Hamame CM, Dalal SS, Bertrand O, Minotti L, Kahane P, Lachaux JP. Efficient "pop-out" visual search elicits sustained broadband gamma activity in the dorsal attention network. J Neurosci. 2012 Mar 7;32(10):3414-21. doi: 10.1523/JNEUROSCI.6048-11.2012.
- Background: PubMed 29410414Ezzyat Y, Wanda PA, Levy DF, Kadel A, Aka A, Pedisich I, Sperling MR, Sharan AD, Lega BC, Burks A, Gross RE, Inman CS, Jobst BC, Gorenstein MA, Davis KA, Worrell GA, Kucewicz MT, Stein JM, Gorniak R, Das SR, Rizzuto DS, Kahana MJ. Closed-loop stimulation of temporal cortex rescues functional networks and improves memory. Nat Commun. 2018 Feb 6;9(1):365. doi: 10.1038/s41467-017-02753-0.
- Background: PubMed 24864167Reilly C, Atkinson P, Das KB, Chin RF, Aylett SE, Burch V, Gillberg C, Scott RC, Neville BG. Neurobehavioral comorbidities in children with active epilepsy: a population-based study. Pediatrics. 2014 Jun;133(6):e1586-93. doi: 10.1542/peds.2013-3787.
- Background: PubMed 31981780Perrone-Bertolotti M, El Bouzaidi Tiali S, Vidal JR, Petton M, Croize AC, Deman P, Rheims S, Minotti L, Bhattacharjee M, Baciu M, Kahane P, Lachaux JP. A real-time marker of object-based attention in the human brain. A possible component of a "gate-keeping mechanism" performing late attentional selection in the Ventro-Lateral Prefrontal Cortex. Neuroimage. 2020 Apr 15;210:116574. doi: 10.1016/j.neuroimage.2020.116574. Epub 2020 Jan 23.
- Background: PubMed 34489652Mac-Auliffe D, Chatard B, Petton M, Croize AC, Sipp F, Bontemps B, Gannerie A, Bertrand O, Rheims S, Kahane P, Lachaux JP. The Dual-Task Cost Is Due to Neural Interferences Disrupting the Optimal Spatio-Temporal Dynamics of the Competing Tasks. Front Behav Neurosci. 2021 Aug 19;15:640178. doi: 10.3389/fnbeh.2021.640178. eCollection 2021.
- Individual participant dataSharing planned: Yes. All anonymized data will be made available upon request by the online publication date
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego Mac-Auliffe, Postdoc principal investigator
The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention Intervention using a customized BCI decoder and Attention Intervention without using a customized BCI decoder in people with Epilepsy in Children and Epilepsy, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained attention as assessed by Conners Continuous Performance Test, 3rd Edition (time frame: Perioperative/periprocedural, and 3 months after hospital discharge). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06940089, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.