NCT05283265

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Apr 2022Oct 2026

First Submitted

Initial submission to the registry

February 9, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

April 8, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2026

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

4.5 years

First QC Date

February 9, 2022

Last Update Submit

March 9, 2026

Conditions

Keywords

NeurophysiologicalLanguage ComprehensionDirect brain stimulationSelf-paced reading

Outcome Measures

Primary Outcomes (7)

  • Behavioral Response- Picture Choice

    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.

    Measured immediately after the intervention

  • Behavioral Response - Self-paced word response time for words presented before electrical stimulation

    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.

    Outcomes will be measured immediately before the intervention

  • Behavioral Response - Self-paced word response time for words presented concomitant with electrical stimulation

    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.

    Outcomes will be measured concomitant with the intervention

  • Behavioral Response - Self-paced word response time for words presented after electrical stimulation

    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

    Outcomes will be measured immediately after the intervention

  • Neural activation before electrical stimulation

    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

    Outcomes will be measured immediately before the intervention

  • Neural activation concomitant with electrical stimulation

    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

    Outcomes will be measured concomitant with the intervention

  • Neural activation after electrical stimulation

    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

    Outcomes will be measured immediately after the intervention

Study Arms (1)

Intracranial patients

EXPERIMENTAL

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.

Behavioral: Sentence TypeOther: Direct brain stimulation

Interventions

Sentence TypeBEHAVIORAL

Subjects read different types of sentences (object-relative, subject -relative and control sentences) to observe how that sentence affects their intracranially recorded neural activity.

Intracranial patients

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.

Also known as: Intracranial stimulation
Intracranial patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age less than 18 years
  • Unable to competently perform control trials of the task

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Alabama at Birmingham Hospital

Birmingham, Alabama, 35294, United States

RECRUITING

Related Publications (12)

  • Nelson MJ, El Karoui I, Giber K, Yang X, Cohen L, Koopman H, Cash SS, Naccache L, Hale JT, Pallier C, Dehaene S. Neurophysiological dynamics of phrase-structure building during sentence processing. Proc Natl Acad Sci U S A. 2017 May 2;114(18):E3669-E3678. doi: 10.1073/pnas.1701590114. Epub 2017 Apr 17.

    PMID: 28416691BACKGROUND
  • Fedorenko E, Scott TL, Brunner P, Coon WG, Pritchett B, Schalk G, Kanwisher N. Neural correlate of the construction of sentence meaning. Proc Natl Acad Sci U S A. 2016 Oct 11;113(41):E6256-E6262. doi: 10.1073/pnas.1612132113. Epub 2016 Sep 26.

    PMID: 27671642BACKGROUND
  • Manning JR, Jacobs J, Fried I, Kahana MJ. Broadband shifts in local field potential power spectra are correlated with single-neuron spiking in humans. J Neurosci. 2009 Oct 28;29(43):13613-20. doi: 10.1523/JNEUROSCI.2041-09.2009.

    PMID: 19864573BACKGROUND
  • King JR, Dehaene S. Characterizing the dynamics of mental representations: the temporal generalization method. Trends Cogn Sci. 2014 Apr;18(4):203-10. doi: 10.1016/j.tics.2014.01.002. Epub 2014 Mar 2.

    PMID: 24593982BACKGROUND
  • De Ridder D, Perera S, Vanneste S. State of the Art: Novel Applications for Cortical Stimulation. Neuromodulation. 2017 Apr;20(3):206-214. doi: 10.1111/ner.12593. Epub 2017 Mar 28.

    PMID: 28371170BACKGROUND
  • Pallier C, Devauchelle AD, Dehaene S. Cortical representation of the constituent structure of sentences. Proc Natl Acad Sci U S A. 2011 Feb 8;108(6):2522-7. doi: 10.1073/pnas.1018711108. Epub 2011 Jan 11.

    PMID: 21224415BACKGROUND
  • Miller KJ, Sorensen LB, Ojemann JG, den Nijs M. Power-law scaling in the brain surface electric potential. PLoS Comput Biol. 2009 Dec;5(12):e1000609. doi: 10.1371/journal.pcbi.1000609. Epub 2009 Dec 18.

    PMID: 20019800BACKGROUND
  • Ray S, Maunsell JH. Different origins of gamma rhythm and high-gamma activity in macaque visual cortex. PLoS Biol. 2011 Apr;9(4):e1000610. doi: 10.1371/journal.pbio.1000610. Epub 2011 Apr 12.

    PMID: 21532743BACKGROUND
  • Mesulam MM, Wieneke C, Hurley R, Rademaker A, Thompson CK, Weintraub S, Rogalski EJ. Words and objects at the tip of the left temporal lobe in primary progressive aphasia. Brain. 2013 Feb;136(Pt 2):601-18. doi: 10.1093/brain/aws336. Epub 2013 Jan 29.

    PMID: 23361063BACKGROUND
  • Keller CJ, Honey CJ, Megevand P, Entz L, Ulbert I, Mehta AD. Mapping human brain networks with cortico-cortical evoked potentials. Philos Trans R Soc Lond B Biol Sci. 2014 Oct 5;369(1653):20130528. doi: 10.1098/rstb.2013.0528.

    PMID: 25180306BACKGROUND
  • Cuello Oderiz C, von Ellenrieder N, Dubeau F, Eisenberg A, Gotman J, Hall J, Hincapie AS, Hoffmann D, Job AS, Khoo HM, Minotti L, Olivier A, Kahane P, Frauscher B. Association of Cortical Stimulation-Induced Seizure With Surgical Outcome in Patients With Focal Drug-Resistant Epilepsy. JAMA Neurol. 2019 Sep 1;76(9):1070-1078. doi: 10.1001/jamaneurol.2019.1464.

    PMID: 31180505BACKGROUND
  • Goldstein HE, Smith EH, Gross RE, Jobst BC, Lega BC, Sperling MR, Worrell GA, Zaghloul KA, Wanda PA, Kahana MJ, Rizzuto DS, Schevon CA, McKhann GM, Sheth SA. Risk of seizures induced by intracranial research stimulation: analysis of 770 stimulation sessions. J Neural Eng. 2019 Nov 11;16(6):066039. doi: 10.1088/1741-2552/ab4365.

    PMID: 31509808BACKGROUND

Related Links

MeSH Terms

Conditions

Language Disorders

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Matthew Nelson, PhD

    The University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Nelson, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 9, 2022

First Posted

March 16, 2022

Study Start

April 8, 2022

Primary Completion (Estimated)

October 8, 2026

Study Completion (Estimated)

October 8, 2026

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.

Locations