Clinically Isolated Syndrome (CIS), Multiple Sclerosis (MS)
Conditions
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.
Interventions
None listed
Sponsors
NeuroCure Clinical Research Center, Charite, Berlin
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emotional modulation of motor response time | 1 day | Δ (\[Response time following neutral stimuli\] - \[Response time following emotional stimuli\]) |
| Emotional memory performance | 1 day | %-correct recognized emotional and neutral stimuli |
| Emotional experience | 1 day | Subjective valence and arousal ratings of emotional and neutral stimuli |
Secondary
| Measure | Time frame |
|---|---|
| Short Form Health Survey (SF-36) | 1 day |
| Satisfaction With Life Scale (SWLS) | 1 day |
| Paced Auditory Serial Addition Test (PASAT) | 1 day |
| BOLD-fMRI brain responses during emotional processing | 1 day |
| Symbol Digit Modalities Test (SDMT) | 1 day |
| Beck depression inventory BDI-2 | 1 day |
| Positive and Negative Affect Schedule (PANAS) | 1 day |
| Serial Reaction Time (SRT) Task | 1 day |
| Expanded Disability Status Scale (EDSS) | 1 day |
| Multiple Sclerosis Functional Composite (MSFC) | 1 day |
Countries
Germany
Outcome results
None listed