Charité Unversitätsmedizin Berlin; NeuroCure Clinical Research Center NCRC
Berlin, 10117, Germany
Completed
NCT Number: NCT02695394
Emotional Processing in Multiple Sclerosis / Clinically Isolated Syndrome: A Neuropsychological fMRI-study
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–84 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Emotional modulation of motor response time
Time frame: 1 day
Δ ([Response time following neutral stimuli] - [Response time following emotional stimuli])
-
Emotional memory performance
Time frame: 1 day
%-correct recognized emotional and neutral stimuli
-
Emotional experience
Time frame: 1 day
Subjective valence and arousal ratings of emotional and neutral stimuli
Secondary outcomes
-
BOLD-fMRI brain responses during emotional processing
Time frame: 1 day
-
Expanded Disability Status Scale (EDSS)
Time frame: 1 day
-
Multiple Sclerosis Functional Composite (MSFC)
Time frame: 1 day
-
Short Form Health Survey (SF-36)
Time frame: 1 day
-
Satisfaction With Life Scale (SWLS)
Time frame: 1 day
-
Paced Auditory Serial Addition Test (PASAT)
Time frame: 1 day
-
Serial Reaction Time (SRT) Task
Time frame: 1 day
-
Symbol Digit Modalities Test (SDMT)
Time frame: 1 day
-
Beck depression inventory BDI-2
Time frame: 1 day
-
Positive and Negative Affect Schedule (PANAS)
Time frame: 1 day
Sponsors and collaborators
Lead sponsor
Charite University, Berlin, Germany
Other
Collaborators
- NeuroCure Clinical Research Center, Charite, Berlin
Registry information
Important dates
- Study start
- 2016
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Mar 1, 2016
- Registry last updated
- Jul 17, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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