Invasive Brain-Computer Interfaces for Attention

NCT06940089 | Withdrawn

• 1 other identifier: STUDY00003744
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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:

• 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.

Conditions

Epilepsy in Children; Epilepsy

Keywords

BCI; Brain Computer Interface; Brain-Computer Interface; Attention; Attention deficit; Epilepsy

Outcome Measures

Primary Outcomes (8)

• 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)

  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

  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

  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

  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

  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.

  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.

  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.

  Perioperative/periprocedural

Secondary Outcomes (7)

• BCI Performance: Accuracy

  Perioperative/periprocedural

• BCI Performance: Sensitivity

  Perioperative/periprocedural

• BCI Performance: Specificity

  Perioperative/periprocedural

• BCI Performance: Precision

  Perioperative/periprocedural

• BCI Performance: F1 Score

  Perioperative/periprocedural

Study Arms (2)

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

Interventions

Attention Intervention using a customized BCI decoder BEHAVIORAL

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.

This arm will receive visual feedback controlled by its own BCI

Attention Intervention without using a customized BCI decoder BEHAVIORAL

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.

This arm will receive visual feedback from another randomly selected participant

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Dell Children's Medical Center

Austin, Texas, 78723, United States

Location

Related Publications (5)

• 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.

  PMID: 22399764 BACKGROUND

• Ezzyat 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.

  PMID: 29410414 BACKGROUND

• Reilly 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.

  PMID: 24864167 BACKGROUND

• Perrone-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.

  PMID: 31981780 BACKGROUND

• Mac-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.

  PMID: 34489652 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Diego Mac-Auliffe, Postdoc

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 23, 2025
• Study Start: May 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available by the online publication date
• Access Criteria: Data will be shared upon request to the PIs

Locations

US (1)