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

Multiple Sclerosis (MS) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02695394
• Other study ID #: EA1/126/15
• Status: Completed
• Start date: February 2016
• Est. completion date: December 2016

Study information

• Verified date: July 2020
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinically Isolated Syndrome (CIS)
• Multiple Sclerosis
• Multiple Sclerosis (MS)
• Sclerosis
• Syndrome

Locations

Country	Name	City	State
Germany	Charité Unversitätsmedizin Berlin; NeuroCure Clinical Research Center NCRC	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	NeuroCure Clinical Research Center, Charite, Berlin

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Hälbig TD, Wüstenberg T, Giess RM, Kunte H, Bellmann-Strobl J, Ruprecht K, Paul F. Emotional experience in patients with clinically isolated syndrome and early multiple sclerosis. Eur J Neurol. 2020 Apr 20. doi: 10.1111/ene.14269. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emotional modulation of motor response time	? ([Response time following neutral stimuli] - [Response time following emotional stimuli])	1 day
Primary	Emotional memory performance	%-correct recognized emotional and neutral stimuli	1 day
Primary	Emotional experience	Subjective valence and arousal ratings of emotional and neutral stimuli	1 day
Secondary	BOLD-fMRI brain responses during emotional processing		1 day
Secondary	Expanded Disability Status Scale (EDSS)		1 day
Secondary	Multiple Sclerosis Functional Composite (MSFC)		1 day
Secondary	Short Form Health Survey (SF-36)		1 day
Secondary	Satisfaction With Life Scale (SWLS)		1 day
Secondary	Paced Auditory Serial Addition Test (PASAT)		1 day
Secondary	Serial Reaction Time (SRT) Task		1 day
Secondary	Symbol Digit Modalities Test (SDMT)		1 day
Secondary	Beck depression inventory BDI-2		1 day
Secondary	Positive and Negative Affect Schedule (PANAS)		1 day

External Links

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