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

July 15, 2020 updated by: PD Dr. Thomas Hälbig, Charite University, Berlin, Germany

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité Unversitätsmedizin Berlin; NeuroCure Clinical Research Center NCRC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients will be selected from a academic medical center MS outpatient clinic.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy controls
MS / CIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotional modulation of motor response time
Time Frame: 1 day
Δ ([Response time following neutral stimuli] - [Response time following emotional stimuli])
1 day
Emotional memory performance
Time Frame: 1 day
%-correct recognized emotional and neutral stimuli
1 day
Emotional experience
Time Frame: 1 day
Subjective valence and arousal ratings of emotional and neutral stimuli
1 day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

NeuroCure Clinical Research Center, Charite, Berlin

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

February 11, 2016

First Submitted That Met QC Criteria

February 24, 2016

First Posted (Estimate)

March 1, 2016

Study Record Updates

Last Update Posted (Actual)

July 17, 2020

Last Update Submitted That Met QC Criteria

July 15, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA1/126/15

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Supporting information: Methods and Results

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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