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

Completed

• Conditions: Clinically Isolated Syndrome (CIS); Multiple Sclerosis (MS)

• Registration Number: NCT02695394
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-11
• Study First Submitted QC: 2016-02-24
• Study First Posted: 2016-03-01
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Emotional modulation of motor response time	1 day	Δ (\[Response time following neutral stimuli\] - \[Response time following emotional stimuli\])
Emotional experience	1 day	Subjective valence and arousal ratings of emotional and neutral stimuli
Emotional memory performance	1 day	%-correct recognized emotional and neutral stimuli

Secondary Outcome Measures

Name	Time	Method
Beck depression inventory BDI-2	1 day
Short Form Health Survey (SF-36)	1 day
Expanded Disability Status Scale (EDSS)	1 day
Multiple Sclerosis Functional Composite (MSFC)	1 day
Satisfaction With Life Scale (SWLS)	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
Positive and Negative Affect Schedule (PANAS)	1 day

Trial Locations

Locations (1)

Charité Unversitätsmedizin Berlin; NeuroCure Clinical Research Center NCRC; 🇩🇪 Berlin, Germany