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

NCT02695394 | Completed

• 1 other identifier: EA1/126/15
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis (MS); Clinically Isolated Syndrome (CIS)

Outcome Measures

Primary Outcomes (3)

• Emotional modulation of motor response time

  Δ (\[Response time following neutral stimuli\] - \[Response time following emotional stimuli\])

  1 day

• Emotional memory performance

  %-correct recognized emotional and neutral stimuli

  1 day

• Emotional experience

  Subjective valence and arousal ratings of emotional and neutral stimuli

  1 day

Secondary Outcomes (10)

• BOLD-fMRI brain responses during emotional processing

  1 day

• Expanded Disability Status Scale (EDSS)

  1 day

• Multiple Sclerosis Functional Composite (MSFC)

  1 day

• Short Form Health Survey (SF-36)

  1 day

• Satisfaction With Life Scale (SWLS)

  1 day

Study Arms (2)

MS / CIS

Healthy controls

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Age ≥ 18 years and ≤ 85 years
• Right handed
• For patients: Diagnosis of CIS or diagnosis of MS since ≤5 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• NeuroCure Clinical Research Center, Charite, Berlin: collaborator

Study Sites (1)

Charité Unversitätsmedizin Berlin; NeuroCure Clinical Research Center NCRC

Berlin, 10117, Germany

Location

Related Publications (1)

• 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.

  PMID: 32307769 RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: March 1, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

DE (1)