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Emotional Processing in Multiple Sclerosis / Clinically Isolated Syndrome: A Neuropsychological fMRI-study

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Completed
CT.gov ID
NCT02695394
Collaborator
NeuroCure Clinical Research Center, Charite, Berlin (Other)
60
Enrollment
1
Location
10
Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this prospective non-interventional neuropsychological one visit study involving functional MRI (fMRI) is to ascertain emotional processing in patients with Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) compared to healthy control subjects.

In different experiments, the modulation of cognitive and motor responses by visual emotional information and the ability to discriminate visual emotional stimuli will be tested using experimental behavioral paradigms. Furthermore, functional connectivity and - using fMRI - activations of brain regions known to be involved with emotional processing will be evaluated.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Feb 1, 2016
    Actual Primary Completion Date :
    Dec 1, 2016
    Actual Study Completion Date :
    Dec 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    MS / CIS
    Healthy controls

    Outcome Measures

    Primary Outcome Measures

    1. Emotional modulation of motor response time [1 day]

      Δ ([Response time following neutral stimuli] - [Response time following emotional stimuli])

    2. Emotional memory performance [1 day]

      %-correct recognized emotional and neutral stimuli

    3. Emotional experience [1 day]

      Subjective valence and arousal ratings of emotional and neutral stimuli

    Secondary Outcome Measures

    1. BOLD-fMRI brain responses during emotional processing [1 day]

    2. Expanded Disability Status Scale (EDSS) [1 day]

    3. Multiple Sclerosis Functional Composite (MSFC) [1 day]

    4. Short Form Health Survey (SF-36) [1 day]

    5. Satisfaction With Life Scale (SWLS) [1 day]

    6. Paced Auditory Serial Addition Test (PASAT) [1 day]

    7. Serial Reaction Time (SRT) Task [1 day]

    8. Symbol Digit Modalities Test (SDMT) [1 day]

    9. Beck depression inventory BDI-2 [1 day]

    10. Positive and Negative Affect Schedule (PANAS) [1 day]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 84 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Age ≥ 18 years and ≤ 85 years

    • Right handed

    • For patients: Diagnosis of CIS or diagnosis of MS since ≤5 years

    Exclusion Criteria:

    • Cognitive deficits as determined by a MMSE Score < 25/30

    • Depression as determined by a HADS-D Score > 7

    • Anxiety as determined by a HADS-A Score > 7

    • Physical disabilities interfering with the study procedures or impacting outcome measures

    • Clinically significant diseases within 7 days prior to the study evaluations

    • Contraindications against cranial MRI without contrast

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Charité Unversitätsmedizin Berlin; NeuroCure Clinical Research Center NCRC Berlin Germany 10117

    Sponsors and Collaborators

    • Charite University, Berlin, Germany
    • NeuroCure Clinical Research Center, Charite, Berlin

    Investigators

    • Principal Investigator: Friedemann Paul, MD, Charité Unversitätsmedizin Berlin, NeuroCure Clinical Research Center NCRC
    • Principal Investigator: Thomas D. Hälbig, MD, Charité Unversitätsmedizin Berlin, NeuroCure Clinical Research Center NCRC

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    PD Dr. Thomas Hälbig, MD, Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT02695394
    Other Study ID Numbers:
    • EA1/126/15
    First Posted:
    Mar 1, 2016
    Last Update Posted:
    Jul 17, 2020
    Last Verified:
    Jul 1, 2020
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Syndrome
    Sclerosis

    Study Results

    No Results Posted as of Jul 17, 2020