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Clinical Trials/NCT02695394
NCT02695394
Completed
Not Applicable

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

Charite University, Berlin, Germany1 site in 1 country60 target enrollmentFebruary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis (MS)
Sponsor
Charite University, Berlin, Germany
Enrollment
60
Locations
1
Primary Endpoint
Emotional memory performance
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
December 2016
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

PD Dr. Thomas Hälbig

MD

Charite University, Berlin, Germany

Eligibility Criteria

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

Outcomes

Primary Outcomes

Emotional memory performance

Time Frame: 1 day

%-correct recognized emotional and neutral stimuli

Emotional modulation of motor response time

Time Frame: 1 day

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

Emotional experience

Time Frame: 1 day

Subjective valence and arousal ratings of emotional and neutral stimuli

Secondary Outcomes

  • Satisfaction With Life Scale (SWLS)(1 day)
  • Short Form Health Survey (SF-36)(1 day)
  • Expanded Disability Status Scale (EDSS)(1 day)
  • Multiple Sclerosis Functional Composite (MSFC)(1 day)
  • Symbol Digit Modalities Test (SDMT)(1 day)
  • Serial Reaction Time (SRT) Task(1 day)
  • BOLD-fMRI brain responses during emotional processing(1 day)
  • Paced Auditory Serial Addition Test (PASAT)(1 day)
  • Beck depression inventory BDI-2(1 day)
  • Positive and Negative Affect Schedule (PANAS)(1 day)

Study Sites (1)

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