Clinical trial NCT06940089: Invasive Brain-Computer Interfaces for Attention
Official title: Invasive Brain-Computer Interfaces for Attention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy in Children
Epilepsy
Keywords: BCI
Brain Computer Interface
Brain-Computer Interface
Attention
Attention deficit
Epilepsy
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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:

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.

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.

Eligibility 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

Primary outcomes:
measure: Sustained attention as assessed by Conners Continuous Performance Test, 3rd Edition
timeFrame: Perioperative/periprocedural, and 3 months after hospital discharge
measure: Working memory as assessed by WISC-IV/WISC-V or WAIS-III/WAIS-IV
timeFrame: Perioperative/periprocedural, and 3 months after hospital discharge
measure: Executive function as assessed by Verbal Fluency and Trail Making, of the Delis-Kaplan Executive Function System
timeFrame: Perioperative/periprocedural, and 3 months after hospital discharge
measure: Executive function as assessed by Behavior Rating Inventory of Executive Function, 2nd edition
timeFrame: Perioperative/periprocedural, and 3 months after hospital discharge
measure: Subjective Attention Self-Report Visual Analog Scale (SASR-VAS)
timeFrame: Perioperative/periprocedural, and 3 months after hospital discharge
measure: Markers of plasticity as assessed by Functional MRI
timeFrame: Perioperative/periprocedural
measure: Change on activity as assessed by iEEG Recordings: Attentive
timeFrame: Perioperative/periprocedural
measure: Change on activity as assessed by iEEG Recordings: Resting
timeFrame: Perioperative/periprocedural
Secondary outcomes:
measure: BCI Performance: Accuracy
timeFrame: Perioperative/periprocedural
measure: BCI Performance: Sensitivity
timeFrame: Perioperative/periprocedural
measure: BCI Performance: Specificity
timeFrame: Perioperative/periprocedural
measure: BCI Performance: Precision
timeFrame: Perioperative/periprocedural
measure: BCI Performance: F1 Score
timeFrame: Perioperative/periprocedural
measure: BCI Performance: Matthews Correlation Coefficient (MCC)
timeFrame: Perioperative/periprocedural
measure: Experiment Performance: Correct Trials per Session
timeFrame: Perioperative/periprocedural
Other outcomes:
Locations:
city: Austin
country: United States
facility: Dell Children's Medical Center
state: Texas
Study officials:
affiliation: The University of Texas at Austin
name: Diego Mac-Auliffe, Postdoc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.