- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04652856
Neurocognitive Basis of Attention and Eye Movement Guidance in the Real World Scenes
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The ability to conduct a visual search for an object in a naturalistic scene is a crucial component of everyday interactions with the environment. This process requires the recognition of different items, accessing stored semantic knowledge about those items and their relationships with other objects, and guiding vision based on that knowledge. Classical models of attention emphasize low-level visual salience maps for attentional guidance. However, behavioral studies increasingly support a role for object knowledge in guiding attention and eye movements. Despite strong behavioral evidence that conceptual information about objects and scenes is critical for real world guidance of attention, very little is known about the neural basis of the guidance of attention based on meaning.
Previous human imaging studies have identified several brain regions that represent object and scene/context knowledge as it relates to visual recognition. In particular, regions of the temporal lobes (inferior temporal regions (ITC), parahippocampal cortex (PHC), and the hippocampus) are critical for perceiving and understanding objects, but little is known about the role of these individual regions in how they interact to guide attention and eye movements in real-world scenes.
Electrical brain stimulation is routinely performed clinically in the surgical treatment of epilepsy patients, both intraoperatively and using implanted electrodes. It is used as standard of care both to map eloquent brain function prior to surgical treatment for epilepsy and to map the seizure network. The purpose of this study is to gain a better understanding of the information flow and neural dynamics of the brain, examining the impact of electrical brain stimulation on stimulus search time, accuracy, and eye movement trajectories.
Tipo di studio
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15213
- UPMC Presbyterian
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Have intracranial EEG electrodes implanted for stage II epilepsy planning.
- Have adequate cognitive and communication ability to give informed consent, understand instructions, and follow direction.
- Be able to understand the tasks and provide responses.
- IQ > 75 (done as part of standard-of-care neuropsychological testing as part of the surgical treatment for epilepsy)
- Speak English
Exclusion Criteria:
- Inability to understand or perform the tasks outlined in this protocol
- In excessive postoperative discomfort.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Electrical and Sham Electrical Brain Stimulation
Electrical brain stimulation and sham electrical brain stimulation will be administered to all participants.
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Electrical Brain Stimulation (EBS) will be used to disrupt local neural activity in inferior temporal regions (ITC), parahippocampal cortex (PHC), the hippocampus, and control regions.
The effects of EBS will be examined on attention and eye movement behavior, and all participants will receive both EBS and sham electrical brain stimulation.
Sham electrical brain stimulation (SEBS) will be applied to inferior temporal regions (ITC), parahippocampal cortex (PHC), the hippocampus, and control regions.
The effects of SEBS will be examined on attention and eye movement behavior, and all participants will receive both SEBS and EBS.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Incidence of eye fixations during electrical brain stimulation (EBS) vs. sham electrical brain stimulation (SEBS).
Lasso di tempo: Eye fixation incidence will be assessed during the intervention, through study completion, up to 1 week on average.
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Eye fixations will be assessed using an eye tracking device, which collects videos of eye movements.
Participants will be presented with an image of a scene, and asked to locate a target object.
The incidence of eye fixations occurring before participants locate the target object will be measured at preferred and control brain regions during EBS and SEBS.
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Eye fixation incidence will be assessed during the intervention, through study completion, up to 1 week on average.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Search time for target object during EBS vs. SEBS.
Lasso di tempo: Search Time will be assessed during the intervention, through study completion, up to 1 week on average.
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Visual search time will be assessed by asking participants to answer a simple question about a target object in an image of a scene as quickly and accurately as possible.
The question will presented to the participants, followed by the image of the scene.
The search time to locate the target object and respond to the question will be measured at preferred and control brain regions during EBS and SEBS.
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Search Time will be assessed during the intervention, through study completion, up to 1 week on average.
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Identification accuracy during EBS vs. SEBS.
Lasso di tempo: Identification accuracy will be assessed during the intervention, through study completion, up to 1 week on average.
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Identification accuracy rate will be assessed based on the participants' correct responses for identifying a target object in an image of a scene (described in Outcomes 1 and 2).
The search time to locate the target object will be measured at preferred and control brain regions during EBS and SEBS.
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Identification accuracy will be assessed during the intervention, through study completion, up to 1 week on average.
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Avniel S Ghuman, PhD, University of Pittsburgh
Studiare le date dei record
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Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- STUDY19090010
- 1R21EY030297-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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