NCT03268694

Brief Summary

Purpose: To investigate the electrophysiological correlates of human cognition and affective processing. Participants: Drug-resistant epilepsy patients undergoing epilepsy surgery cortical mapping with continuous electrocorticography (ECoG) with intracranial electrodes. Procedures (methods): Participants will perform computer-based cognitive and affective processing tasks during routine long-term monitoring. Intracranial EEG will be collected during the task

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
terminated

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 Start

First participant enrolled

August 7, 2017

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2018

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

12 months

First QC Date

August 29, 2017

Last Update Submit

January 9, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Intracranial EEG Spectra Power

    Spectral analysis of electrophysiology data will be performed using multi-taper fft and wavelet transforms. The measures will be compared between different epochs within the tasks to determine what oscillations are modulated by the task. The correlation between the measures described above and the task performance will also be estimated.

    Intracranial EEG will be collected simultaneously when the participants perform the task. 1 Hour

Secondary Outcomes (2)

  • Task Performance: Reaction Times

    1 Hour

  • Intracranial EEG Functional Connectivity Analysis

    Intracranial EEG will be collected simultaneously when the participants perform the task. 1 Hour

Study Arms (1)

Cognitive and Emotion Processing Tasks

EXPERIMENTAL

As a part of the clinical monitoring, intracranial EEG is continuously collected when the participant is at the Epilepsy Monitoring Unit at the UNC Neuroscience Hospital. We will use an FDA approved EEG amplifier/data acquisition system to collect the research data. Computer-based tasks will be presented through a laptop and task related timing information will be transmitted from the laptop to the data acquisition system. Computer-based tasks will include Working Memory task, Reward Learning Task and Facial Emotion Recognition Task

Behavioral: Working Memory TaskBehavioral: Reward Learning TaskBehavioral: Facial Emotion Recognition Task

Interventions

Sternberg Task Items, which can be visually presented alphabets, shapes or numbers or sound tones presented through speakers, will be presented to the participant. The participant will need to maintain the presented items in their memory and indicate, when a single probe item is presented, whether the probe item was present in the immediately preceding list by pressing a key on the keyboard. N-Back Task Items are presented continuously sequentially and participants are instructed to indicate whether items are repeated n items before by pressing a key on the keyboard. The task is divided into blocks of 0,1,2,3 -back trials based on the 'n'. For example in the 2 - back task, the participant has to indicate if the item presented 2 items before matches the current item. Similar to the previous task, the items can be presented visually or auditorily.

Also known as: Sternberg Task, N-Back Task
Cognitive and Emotion Processing Tasks

Two abstract visual stimuli are presented on the screen and participant is asked to choose one. Unknown to the participant, each stimulus is associated with distinct probabilities of virtual reward such that one stimulus is associated with net gain while the other is associated with net loss. The participant's goal is to maximize the reward. Once the participant identifies the stimulus associated with net gain, the reward probabilities are reversed. This process is repeated 5 times.

Also known as: Learning reversal task
Cognitive and Emotion Processing Tasks

On a given trial, participants will be presented with images of two faces side-by-side. The faces will either match in terms of emotion category (e.g., 2 anger faces) or not (e.g., an anger face and a fear face). Faces presented together will always be of the same gender but different identities. Participants will be asked to determine whether the two faces presented depict the same emotion category.

Cognitive and Emotion Processing Tasks

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of medically intractable epilepsy
  • Capable of giving informed consent
  • Aged 18 - 80 years, either sex

You may not qualify if:

  • Major systemic illness
  • Severe cognitive impairment defined as mini-mental state examination of less than 20
  • Severe psychiatric illness
  • Excessive use of alcohol or other substances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (12)

  • Hsieh LT, Ranganath C. Frontal midline theta oscillations during working memory maintenance and episodic encoding and retrieval. Neuroimage. 2014 Jan 15;85 Pt 2(0 2):721-9. doi: 10.1016/j.neuroimage.2013.08.003. Epub 2013 Aug 8.

    PMID: 23933041BACKGROUND
  • Klimesch W. alpha-band oscillations, attention, and controlled access to stored information. Trends Cogn Sci. 2012 Dec;16(12):606-17. doi: 10.1016/j.tics.2012.10.007. Epub 2012 Nov 7.

    PMID: 23141428BACKGROUND
  • Sauseng P, Klimesch W, Heise KF, Gruber WR, Holz E, Karim AA, Glennon M, Gerloff C, Birbaumer N, Hummel FC. Brain oscillatory substrates of visual short-term memory capacity. Curr Biol. 2009 Nov 17;19(21):1846-52. doi: 10.1016/j.cub.2009.08.062.

    PMID: 19913428BACKGROUND
  • Symons AE, El-Deredy W, Schwartze M, Kotz SA. The Functional Role of Neural Oscillations in Non-Verbal Emotional Communication. Front Hum Neurosci. 2016 May 25;10:239. doi: 10.3389/fnhum.2016.00239. eCollection 2016.

    PMID: 27252638BACKGROUND
  • Bonnefond M, Jensen O. Alpha oscillations serve to protect working memory maintenance against anticipated distracters. Curr Biol. 2012 Oct 23;22(20):1969-74. doi: 10.1016/j.cub.2012.08.029. Epub 2012 Oct 4.

    PMID: 23041197BACKGROUND
  • Khader PH, Jost K, Ranganath C, Rosler F. Theta and alpha oscillations during working-memory maintenance predict successful long-term memory encoding. Neurosci Lett. 2010 Jan 14;468(3):339-43. doi: 10.1016/j.neulet.2009.11.028. Epub 2009 Nov 14.

    PMID: 19922772BACKGROUND
  • Miller EK, Buschman TJ. Cortical circuits for the control of attention. Curr Opin Neurobiol. 2013 Apr;23(2):216-22. doi: 10.1016/j.conb.2012.11.011. Epub 2012 Dec 22.

    PMID: 23265963BACKGROUND
  • Bastos AM, Vezoli J, Bosman CA, Schoffelen JM, Oostenveld R, Dowdall JR, De Weerd P, Kennedy H, Fries P. Visual areas exert feedforward and feedback influences through distinct frequency channels. Neuron. 2015 Jan 21;85(2):390-401. doi: 10.1016/j.neuron.2014.12.018. Epub 2014 Dec 31.

    PMID: 25556836BACKGROUND
  • Jacobs J, Kahana MJ. Direct brain recordings fuel advances in cognitive electrophysiology. Trends Cogn Sci. 2010 Apr;14(4):162-71. doi: 10.1016/j.tics.2010.01.005. Epub 2010 Feb 25.

    PMID: 20189441BACKGROUND
  • Mendez-Bertolo C, Moratti S, Toledano R, Lopez-Sosa F, Martinez-Alvarez R, Mah YH, Vuilleumier P, Gil-Nagel A, Strange BA. A fast pathway for fear in human amygdala. Nat Neurosci. 2016 Aug;19(8):1041-9. doi: 10.1038/nn.4324. Epub 2016 Jun 13.

    PMID: 27294508BACKGROUND
  • Huijgen J, Dinkelacker V, Lachat F, Yahia-Cherif L, El Karoui I, Lemarechal JD, Adam C, Hugueville L, George N. Amygdala processing of social cues from faces: an intracrebral EEG study. Soc Cogn Affect Neurosci. 2015 Nov;10(11):1568-76. doi: 10.1093/scan/nsv048. Epub 2015 May 11.

    PMID: 25964498BACKGROUND
  • Murray RJ, Brosch T, Sander D. The functional profile of the human amygdala in affective processing: insights from intracranial recordings. Cortex. 2014 Nov;60:10-33. doi: 10.1016/j.cortex.2014.06.010. Epub 2014 Jun 19.

    PMID: 25043736BACKGROUND

Study Officials

  • Flavio Frohlich, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR
  • Hae Won Shin, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2017

First Posted

August 31, 2017

Study Start

August 7, 2017

Primary Completion

July 29, 2018

Study Completion

July 29, 2018

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations