NCT04684797

Brief Summary

The exact function of the anterior cingulate cortex (ACC) is one of the largest riddles in cognitive neuroscience and a major challenge in mental health research. ACC dysfunction contributes to a broad spectrum of neurological and psychiatric disorders, such as depression, ADHD, Parkinson's disease, OCD and many others, but nobody knows what it actually does. Recently a new theory has been developed about ACC function; the HRL-ACC (Hierarchical Reinforcement Learning Theory of ACC). This theory proposes that the ACC selects and motivates high-level tasks based on the principles of hierarchical reinforcement learning. The ACC associates values with tasks, selects the correct tasks and applies control over other neural networks (such as the dorsolateral prefrontal cortex and basal ganglia), which execute the tasks. The values of these tasks are attributed based on "reward prediction error signals", which are sent from the midbrain dopamine system to the ACC. These signals can be recorded using scalp-EEG as an "event-related brain potential" (ERP), which is called the "reward positivity". Until this day, the exact origin of the reward positivity is not yet known. Studies have delivered strong indirect evidence that the reward positivity is generated in the ACC. However, there is an important lack of direct evidence to support this hypothesis. The goal of this study is to provide direct evidence that the reward positivity is generated in the ACC by letting a group of patients with refractory epilepsy perform the virtual T-maze task (which is known to elicit reward positivity) and simultaneously recording intracranial video-EEG.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 4, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

3.6 years

First QC Date

December 21, 2020

Last Update Submit

January 4, 2024

Conditions

Keywords

Anterior Cingulate CortexReward positivity

Outcome Measures

Primary Outcomes (1)

  • Distribution of reward positivity amplitude

    Calculation of amplitude of reward positivity ERP-component recorded by intracranial electrodes and scalp-distribution of amplitude across all subjects

    Date of inclusion to date of second session (about one month)

Secondary Outcomes (1)

  • Location in brain most likely to represent source of reward positivity

    Date of inclusion to date of second session (about one month)

Study Arms (1)

Intervention group

EXPERIMENTAL

Each participant will undergo two sessions, consisting of performing the virtual T-maze task, scalp-EEG recording and/or intracranial video-EEG recording.

Behavioral: Virtual T-maze task

Interventions

Patients will have to perform the virtual T-maze task, which is known to elicit reward positivity. During this task, the patients will see a virtual T-maze on a computer screen and have to choose at every junction whether they go right or left. Depending on the direction they choose, they either get positive or negative feedback (reward or no reward). This feedback is chosen completely at random, on a 50% reward/50% no reward basis.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Age 18 years or older
  • Patients with refractory epilepsy
  • Planned hospitalization at CNM for invasive video-EEG recording with subdural, epidural and/or depth electrodes
  • Patients have to be able to give informed consent themselves
  • Imaging after placement of electrodes (CT and/or MRI) has to be available

You may not qualify if:

  • Patients known with dementia or severe cognitive and/or psychiatric disorders that makes it impossible for patients to participate in this study
  • Active alcohol and/or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, University Hospital Ghent

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Alfred Meurs, MD PhD

    University Hospital Ghent, Department of Neurology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alfred Meurs, MD 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
SPONSOR

Study Record Dates

First Submitted

December 21, 2020

First Posted

December 28, 2020

Study Start

March 4, 2021

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations