Causal Evidence for Task Regulation by Anterior Cingulate Cortex

NCT04650425 | Unknown DMC

• 1 other identifier: BC-08764
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 (these values are based on the reward positivity produced by the midbrain dopamine system), 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 goal of this study is to investigate the consequences of ACC damage (and other areas of the frontal lobe) on task regulation within a group of patients who have suffered a stroke in the frontal lobe. Furthermore, the correlation between ACC damage and mood disorders such as depression and apathy is going to be investigated.

Conditions

Stroke

Keywords

Anterior Cingulate Cortex

Outcome Measures

Primary Outcomes (5)

• Incidence and type of mistakes made during the coffee-tea task

  Analysed and compared within sub-groups (classified by using Voxel-based Lesion Symptom Mapping)

  date of inclusion to date of second session, assessed up to 6 to 12 months

• Amplitude of reward positivity Event-Related Potential signals

  Relationship between reward positivity amplitude and brain damage, investigated by using Voxel-based Lesion Symptom Mapping.

  date of inclusion to date of second session, assessed up to 6 to 12 months

• Neurofunctional status

  Neurofunctional status as defined by the Oxford Cognitive Score, a scale ranging from 0 to 138 (the higher the score, the better the neurofunctional status)

  6 to 12 months after stroke

• Presence of depression

  Presence and severity of depression, evaluated by using the Becker Depression Inventory, a scale that scores from 0 to 63 (the higher the score, the more severe the depression).

  6 to 12 months after stroke

• Presence of apathy

  Presence and severity of apathy, evaluated by using the DEX (Dysexecutive) Questionnaire, a scale that scores from 0 to 80 and that is filled in both by the patient and the independent caretaker (e.g. family, friend). The higher the score, the more severe the apathy and dysexecutive problems.

  6 to 12 months after stroke

Secondary Outcomes (1)

• Performance of coffee-tea task in subgroup with ACC lesions

  date of inclusion to date of second session, assessed up to 6 to 12 months

Study Arms (1)

Intervention group

EXPERIMENTAL

Each participant will undergo one or two sessions, consisting of cognitive tasks, video-EEG recording and administering of questionnaires.

Behavioral: Cognitive tasks

Interventions

Cognitive tasks BEHAVIORAL

Patients will perform the coffee-tea task and the virtual T-maze task, both in the acute and chronic phase after stroke.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke patients: ischemic stroke or intracranial hemorrhage
• Involvement of the frontal lobe
• Lesion is visible on CT and/or MRI and is concordant with clinical presentation during the time of onset
• Patients have to be able to give informed consent themselves

You may not qualify if:

• Patients with a TIA, i.e. no visible lesion on CT and/or MRI or symptoms less than 24 hours
• Patients with decreased alertness or disorders of consciousness, which makes it impossible for these patients to participate in the experiments
• Active alcohol and/or drug abuse/addiction
• Patients diagnosed with dementia or another neurodegenerative disease, or severe cognitive and/or psychiatric disorders that make it impossible for these patients to participate in the study
• Patients with severe aphasia (as defined by NIHSS score)

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Neurology: collaborator

Study Sites (1)

University Hospital, department of neurology

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Veerle De Herdt

  University Hospital Ghent, Department of Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veerle De Herdt

CONTACT

+3293326481; veerle.deherdt@uzgent.Be

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: November 12, 2020
• First Posted: December 2, 2020
• Study Start: April 29, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-12

Locations

BE (1)