Emotion Recognition and Social Cognition in JME patients

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00011216
• Date of registration: 21/10/2016
• Prospective Registration: Yes
• Primary sponsor: Universitätsklinik für Neurologie der Paracelsus medizinischen Privatuniversität Salzburg
• Public title: Emotion Recognition and Social Cognition in JME patients
• Scientific title: Emotion Recognition and Social Cognition in JME patients
• Date of first enrolment: 01/11/2016
• Target sample size: 200
• Recruitment status: Pending
• URL: http://drks.de/search/en/trial/DRKS00011216
• Study type: observational
• Study design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other

Countries of recruitment

Austria

Contacts

• Name: Eugen Trinka
• Affiliation: Universitätsklinik für Neurologie der Paracelsus medizinischen Privatuniversität Salzburg

• Name: Elisabeth Schmid
• Affiliation: Universitätsklinik für Neurologie der Paracelsus medizinischen Privatuniversität Salzburg

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria for patients:
- Electro-clinical diagnosis of JME based on Classification of the International League against Epilepsy
- Patients aged 14 years or older with willingness to participate in the project (informed consent will be obtained from all patients and/or parents of paediatric patients aged between 14 and 18 years)
- Patients with ability to participate in MRI and fMRI studies

Inclusion criteria for controls (healthy subjects and siblings of patients with JME):
- Healthy subjects and siblings of patients with JME aged 18 years or older with willingness to participate in the study

Exclusion criteria: Exclusion criteria for patients:
- Occurrence of epileptic seizure <72 hours prior to MRI &fMRI study
- Patients with medical and/ or neurological illnesses other than JME (except for cluster B psychiatric disorders)
- Intake of Topiramate and / or Benzodiazepine
- Structural lesion on MRI
- Incompatibility with MRI investigation
- Pregnancy

Exclusion criteria controls (healthy subjects and siblings of patients with JME)::
- Individuals with medical and/ or neurological illnesses
- Individuals with EEG abnormalities (applies to siblings of patients with JME. All of them will undergo routine EEG)
- Structural lesion on MRI
- Incompatibility with MRI investigation
- Pregnancy


Age minimum: 14 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

Juvenile myoclonic epilepsy (JME)
G40

Epilepsy

Intervention(s)

Group 1: Patients: Patients with juvenile myoclonic epilepsy (JME): Visit 1: psychiatric examination;
Visit 2: neuropsychological testing;
Visit 3: structural and functional Imaging.

Group 2: Controls I: healthy subjects: Visit 1: psychiatric examination; Visit 2: neuropsychological testing;
Visit 3: structural and functional Imaging.

Group 3: Controls II: siblings of patients with JME: Visit 1: psychiatric examination; Visit 2: neuropsychological testing; Visit 3: structural and functional Imaging.

Primary Outcome(s)

The main goal of this study is to determine structural and functional substrates of deficits in emotion processing and social cognition in patients with JME.
In order to achieve the main goal we will develop the following strategies:
• Psychiatric profile of JME patients as well as healthy controls and siblings of JME patients will be assessed. JME patients will thereafter be divided into two groups: those with and without Axis I and/or II psychiatric disorders according to DSM IV criteria.
• Emotion processing and social cognition will be assessed by means of specific neuropsychological tests in patients with JME as well as healthy controls and siblings of JME patients. Those tests compose various tests to examine (i) emotion recognition (Facial Expressions of Emotion: Stimuli and Tests (FEEST), Empathy Quotient (EQ)), (ii) Theory of Mind (ToM) tests (Reading the Mind in the Eyes Test, Moving Triangles, Faux Pas Test), (iii) tests to examine executive functions (Wechsler Intelligence Scale for Adults and Children, Wisconsin Card Sorting Test (WCTS), Trail Making Test A & B (TMT A & B), Regensburger Wortflüssigkeitstest (RWT), Toronto-Alexithymia Scale (TAS-26)) as well as (iv) a self-report questionnaire to examine depression and anxiety symptoms (Hospital Anxiety and Depression Scale (HADS-D)).
• Morphological and functional imaging assessment (magnetic resonance imaging (MRI) and functional magnetic resonance imaging (fMRI)) of limbic structures in two groups of JME patients (with and without Axis I and/or II psychiatric disorders) as well as healthy controls andsiblings of JME patients will be performed.
• Imaging and neuropsychological data in two groups of JME patients (with and without Axis I and/or II psychiatric disorders) as well as with the similar data of healthy controls and siblings of JME patients will be compared.
• Imaging and neuropsychological data of two groups of JME patients: those with newly manifested JME (maximum disease duration 3 years) and those with longstanding JME (disease duration over 3 years) as well as with the similar data of healthy controls and siblings of JME patients will be compared.

Source(s) of Monetary Support

Fonds zur Förderung der wissenschaftlichen Forschung (FWF)Haus der Forschung

Paracelsus Medizinische Privatuniversität Salzburg

Ethics review

Status: Approved
Approval date: 26/06/2013
Contact:

Amt der Salzburger Landesregierung Ethikkommission für das Bundesland Salzburg [Amt der Salzburger Landesregierung, Ethikkommission für das Bundesland Salzburg]

Results

• URL: http://drks.de/search/en/trial/DRKS00011216#studyResults