Clinical trial NCT02695394: Emotional Processing in Multiple Sclerosis / Clinically Isolated Syndrome: A Neuropsychological fMRI-study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis (MS)
Clinically Isolated Syndrome (CIS)
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: NeuroCure Clinical Research Center, Charite, Berlin
First posted: 2016-03-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be selected from a academic medical center MS outpatient clinic.

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.


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

Primary outcomes:
measure: Emotional modulation of motor response time
timeFrame: 1 day
measure: Emotional memory performance
timeFrame: 1 day
measure: Emotional experience
timeFrame: 1 day
Secondary outcomes:
measure: BOLD-fMRI brain responses during emotional processing
timeFrame: 1 day
measure: Expanded Disability Status Scale (EDSS)
timeFrame: 1 day
measure: Multiple Sclerosis Functional Composite (MSFC)
timeFrame: 1 day
measure: Short Form Health Survey (SF-36)
timeFrame: 1 day
measure: Satisfaction With Life Scale (SWLS)
timeFrame: 1 day
measure: Paced Auditory Serial Addition Test (PASAT)
timeFrame: 1 day
measure: Serial Reaction Time (SRT) Task
timeFrame: 1 day
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: 1 day
measure: Beck depression inventory BDI-2
timeFrame: 1 day
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: 1 day
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Unversitätsmedizin Berlin; NeuroCure Clinical Research Center NCRC
Study officials:
affiliation: Charité Unversitätsmedizin Berlin, NeuroCure Clinical Research Center NCRC
name: Friedemann Paul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charité Unversitätsmedizin Berlin, NeuroCure Clinical Research Center NCRC
name: Thomas D. Hälbig, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Halbig TD, Wustenberg 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 Aug;27(8):1537-1545. doi: 10.1111/ene.14269. Epub 2020 Jun 12.