Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-05-01
2026-12-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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This arm will receive visual feedback controlled by its own BCI
Attention Intervention 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.
This arm will receive visual feedback from another randomly selected participant
Attention Intervention without using a customized BCI decoder
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.
Interventions
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Attention Intervention 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.
Attention Intervention without using a customized BCI decoder
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
8 Years
21 Years
ALL
No
Sponsors
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University of Texas at Austin
OTHER
Responsible Party
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Jose del R. Millan
Professor
Principal Investigators
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Diego Mac-Auliffe, Postdoc
Role: PRINCIPAL_INVESTIGATOR
The University of Texas at Austin
Locations
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Dell Children's Medical Center
Austin, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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STUDY00003744
Identifier Type: -
Identifier Source: org_study_id
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