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Trial record 1 of 1 for:    NCT02695394
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Emotional Processing in Multiple Sclerosis / Clinically Isolated Syndrome: A Neuropsychological fMRI-study

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ClinicalTrials.gov Identifier: NCT02695394
Recruitment Status : Completed
First Posted : March 1, 2016
Last Update Posted : July 17, 2020
Sponsor:
Collaborator:
NeuroCure Clinical Research Center, Charite, Berlin
Information provided by (Responsible Party):
PD Dr. Thomas Hälbig, 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.


Condition or disease
Multiple Sclerosis (MS) Clinically Isolated Syndrome (CIS)

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : February 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort
MS / CIS
Healthy controls



Primary Outcome Measures :
  1. Emotional modulation of motor response time [ Time Frame: 1 day ]
    Δ ([Response time following neutral stimuli] - [Response time following emotional stimuli])

  2. Emotional memory performance [ Time Frame: 1 day ]
    %-correct recognized emotional and neutral stimuli

  3. Emotional experience [ Time Frame: 1 day ]
    Subjective valence and arousal ratings of emotional and neutral stimuli


Secondary Outcome Measures :
  1. BOLD-fMRI brain responses during emotional processing [ Time Frame: 1 day ]
  2. Expanded Disability Status Scale (EDSS) [ Time Frame: 1 day ]
  3. Multiple Sclerosis Functional Composite (MSFC) [ Time Frame: 1 day ]
  4. Short Form Health Survey (SF-36) [ Time Frame: 1 day ]
  5. Satisfaction With Life Scale (SWLS) [ Time Frame: 1 day ]
  6. Paced Auditory Serial Addition Test (PASAT) [ Time Frame: 1 day ]
  7. Serial Reaction Time (SRT) Task [ Time Frame: 1 day ]
  8. Symbol Digit Modalities Test (SDMT) [ Time Frame: 1 day ]
  9. Beck depression inventory BDI-2 [ Time Frame: 1 day ]
  10. Positive and Negative Affect Schedule (PANAS) [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients will be selected from a academic medical center MS outpatient clinic.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02695394


Locations
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Germany
Charité Unversitätsmedizin Berlin; NeuroCure Clinical Research Center NCRC
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
NeuroCure Clinical Research Center, Charite, Berlin
Investigators
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Principal Investigator: Friedemann Paul, MD Charité Unversitätsmedizin Berlin, NeuroCure Clinical Research Center NCRC
Principal Investigator: Thomas D. Hälbig, MD Charité Unversitätsmedizin Berlin, NeuroCure Clinical Research Center NCRC
Additional Information:
Study Data/Documents: Supporting information: Methods and Results  This link exits the ClinicalTrials.gov site

Publications of Results:
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Responsible Party: PD Dr. Thomas Hälbig, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02695394    
Other Study ID Numbers: EA1/126/15
First Posted: March 1, 2016    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Multiple Sclerosis
Syndrome
Sclerosis
Disease
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases