Recruiting

Observational Study

Sponsor:

University of Alabama at Birmingham

Code:

NCT05283265

Conditions

Language Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sentence Type

Direct brain stimulation

Study Details

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.

Conditions

Language Disorders

Study ID

NCT05283265

Start date

Apr 8, 2022

Status verified date

Mar, 2026

Completion date

Oct 8, 2026

Anticipated

Primary completion date

Oct 8, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

153 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

Primary outcome measure

  • Behavioral Response- Picture Choice [ Time Frame: Measured immediately after the intervention ]
  • Behavioral Response - Self-paced word response time for words presented before electrical stimulation [ Time Frame: Outcomes will be measured immediately before the intervention ]
  • Behavioral Response - Self-paced word response time for words presented concomitant with electrical stimulation [ Time Frame: Outcomes will be measured concomitant with the intervention ]
  • Behavioral Response - Self-paced word response time for words presented after electrical stimulation [ Time Frame: Outcomes will be measured immediately after the intervention ]
  • Neural activation before electrical stimulation [ Time Frame: Outcomes will be measured immediately before the intervention ]
  • Neural activation concomitant with electrical stimulation [ Time Frame: Outcomes will be measured concomitant with the intervention ]
  • Neural activation after electrical stimulation [ Time Frame: Outcomes will be measured immediately after the intervention ]

Central Contacts and Locations

Central contacts

Locations

The University of Alabama at Birmingham Hospital

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

  • Neurophysiological
  • Language Comprehension
  • Direct brain stimulation
  • Self-paced reading

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-03-11.