Neurophysiological Mechanisms of Language Comprehension
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ClinicalTrials.gov Identifier: NCT05283265 |
Recruitment Status :
Recruiting
First Posted : March 16, 2022
Last Update Posted : March 25, 2024
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First, in a recording-only self-paced reading experiment, patients with epilepsy undergoing intracranial monitoring for clinical purposes will read or listen to sentences presented to them one word at time while the investigators simultaneously record neural activity through intracranial electrodes that are implanted for clinical purposes (see subject populations). At the end of the sentence, the subjects have to indicate how they comprehended the sentence by selecting which of several pictures matches the sentence they just read. Behavioral measures that the investigators record and analyze are their response times to advance to each next word in the sentence, and which picture they chose for each sentence. These behavioral measures are compared against the neural activity simultaneously recorded as they are made.
Then, in a later session, the same participants will participate in a task-related stimulation experiment. This follows the exact same design as the recording-only reading experiment, the only difference is that on some trials, at controlled moments during the sentence presentation intracranial electrical stimulation is delivered through adjacent intracranial electrode contacts. The investigators will examine the effect of this stimulation on the subjects comprehension of the sentences measured by their behavior, and on the simultaneously recorded neural activity.
Condition or disease | Intervention/treatment | Phase |
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Language Disorders | Behavioral: Sentence Type Other: Direct brain stimulation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 153 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Neurophysiological Mechanisms of Language Comprehension |
Actual Study Start Date : | April 8, 2022 |
Estimated Primary Completion Date : | October 8, 2026 |
Estimated Study Completion Date : | October 8, 2026 |
Arm | Intervention/treatment |
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Experimental: Intracranial patients
All participants with epilepsy undergoing intracranial monitoring for clinical purposes will be approached to participate in an experiment that is recording-only and an experiment that involves stimulation with simultaneous recording.
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Behavioral: Sentence Type
Subjects read different types of sentences (object-relative, subject -relative and control sentences) to observe how that sentence affects their intracranially recorded neural activity. Other: Direct brain stimulation On some trials the investigators will apply intracranial electrical current through the electrodes implanted in the participants and observe the effect this has on their behavior (which picture they choose at the end of the trial) and the effect this has on their neural activity that the investigators record simultaneously through-out the experiment.
Other Name: Intracranial stimulation |
- Behavioral Response- Picture Choice [ Time Frame: Measured immediately after the intervention ]The investigators will observe which picture the participant chooses at the end of each trial. The participant's choice will be measured by a touch screen that the patient touches to make their choice. The unit of measurement is the percentage of trials per condition studied in which participants choose the correct picture, versus the percentage of trials per condition studied in which participants choose the picture that reflects a patient-agent error (which reflects incorrect assignment of the patient versus agent roles of the nouns in the sentence), versus the percentage of trials per condition studied in which participants choose the picture that reflects a complement error (which reflects that the subjects mistakenly applied an adjective to the wrong noun in the sentence), versus the percentage of trials per condition studied in which participants choose the picture that reflects both a patient-agent and a complement error.
- Behavioral Response - Self-paced word response time for words presented before electrical stimulation [ Time Frame: Outcomes will be measured immediately before the intervention ]While subjects perform self-paced reading experiments, this is the amount of time they spend on each word of the sentence before moving on to the next word of the sentence.
- Behavioral Response - Self-paced word response time for words presented concomitant with electrical stimulation [ Time Frame: Outcomes will be measured concomitant with the intervention ]While subjects perform self-paced reading experiments, this is the amount of time they spend on each word of the sentence before moving on to the next word of the sentence.
- Behavioral Response - Self-paced word response time for words presented after electrical stimulation [ Time Frame: Outcomes will be measured immediately after the intervention ]While subjects perform self-paced reading experiments, this is the amount of time they spend on each word of the sentence before moving on to the next word of the sentence, for words presented after electrical stimulation
- Neural activation before electrical stimulation [ Time Frame: Outcomes will be measured immediately before the intervention ]With the electrodes implanted in the patient as a standard of care, the investigators will measure the neural activation at each electrode as assessed by the high gamma power present in that recorded channel
- Neural activation concomitant with electrical stimulation [ Time Frame: Outcomes will be measured concomitant with the intervention ]With the electrodes implanted in the patient as a standard of care, the investigators will measure the neural activation at each electrode as assessed by the high gamma power present in that recorded channel
- Neural activation after electrical stimulation [ Time Frame: Outcomes will be measured immediately after the intervention ]With the electrodes implanted in the patient as a standard of care, the investigators will measure the neural activation at each electrode as assessed by the high gamma power present in that recorded channel
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 and older
- Undergoing standard of care stereo Electro Encephalogram (sEEG) or Electro-Corticogram (ECoG) monitoring
- Able to competently perform control trials of the task
Exclusion Criteria:
- Age less than 18 years
- Unable to competently perform control trials of the task
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05283265
Contact: Matthew Nelson, PhD | 2059346717 | matthewnelson@uabmc.edu |
United States, Alabama | |
The University of Alabama at Birmingham Hospital | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: Matthew Nelson, MD 205-934-6717 matthewnelson@uabmc.edu |
Principal Investigator: | Matthew Nelson, PhD | The University of Alabama at Birmingham |
Publications:
Responsible Party: | Matthew J. Nelson, Assistant Professor, University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT05283265 |
Other Study ID Numbers: |
IRB-300008888 5K01DC019165 ( U.S. NIH Grant/Contract ) |
First Posted: | March 16, 2022 Key Record Dates |
Last Update Posted: | March 25, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | After publication of the main results, limited access datasets that are free of identifying information will be made available to the scientific community per NIH guidelines in accordance with UAB policies and state and federal regulations. The final dataset will be stripped of identifying information before sharing. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Time Frame: | Data will be made available for a period of 10 years starting 6 months after publication. |
Access Criteria: | All researchers who seek data will be asked to commit to protect privacy and confidentiality, secure the data using appropriate computer technology, refrain from redistributing data to third parties, and destroy or return the data after completion of analyses. The PI will review data sharing requests. Researchers requesting data may be asked to submit in writing a signed statement affirming their commitment to protect privacy and confidentiality. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Neurophysiological Language Comprehension Direct brain stimulation Self-paced reading |
Language Disorders Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |