Multiple Sclerosis (MS)NCT02695394
Emotional Processing in Multiple Sclerosis / Clinically Isolated Syndrome: A Neuropsychological fMRI-study
An observational study of Multiple Sclerosis (MS) and Clinically Isolated Syndrome (CIS), run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis (MS), Clinically Isolated Syndrome (CIS)
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be selected from a academic medical center MS outpatient clinic.
Who may be able to join
- Age ≥ 18 years and ≤ 85 years
- Right handed
- For patients: Diagnosis of CIS or diagnosis of MS since ≤5 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité Unversitätsmedizin Berlin; NeuroCure Clinical Research Center NCRC
Berlin, 10117
About this 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.
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MS / CIS | Not described | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional modulation of motor response time
Δ ([Response time following neutral stimuli] - [Response time following emotional stimuli])
Measured: 1 day
Emotional memory performance
%-correct recognized emotional and neutral stimuli
Measured: 1 day
Emotional experience
Subjective valence and arousal ratings of emotional and neutral stimuli
Measured: 1 day
Secondary outcomes (10)
BOLD-fMRI brain responses during emotional processing
Measured: 1 day
Expanded Disability Status Scale (EDSS)
Measured: 1 day
Multiple Sclerosis Functional Composite (MSFC)
Measured: 1 day
Short Form Health Survey (SF-36)
Measured: 1 day
Satisfaction With Life Scale (SWLS)
Measured: 1 day
Paced Auditory Serial Addition Test (PASAT)
Measured: 1 day
Serial Reaction Time (SRT) Task
Measured: 1 day
Symbol Digit Modalities Test (SDMT)
Measured: 1 day
Beck depression inventory BDI-2
Measured: 1 day
Positive and Negative Affect Schedule (PANAS)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis (MS)Studies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroCure Clinical Research Center, Charite, Berlin
- Responsible party
- Principal investigator, PD Dr. Thomas Hälbig, Charite University, Berlin, Germany
- Investigators
- Friedemann Paul, MD, Principal investigator, Charité Unversitätsmedizin Berlin, NeuroCure Clinical Research Center NCRCThomas D. Hälbig, MD, Principal investigator, Charité Unversitätsmedizin Berlin, NeuroCure Clinical Research Center NCRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695394
- Sponsor's protocol ID
- EA1/126/15
- Status last verified
- Jul 2020
- First submitted
- 11 Feb 2016
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32307769
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Processing in Multiple Sclerosis / Clinically Isolated Syndrome: A Neuropsychological fMRI-study
- ClinicalTrials.gov ID
- NCT02695394
- Acronym / sponsor ID
- EA1/126/15
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- NeuroCure Clinical Research Center, Charite, Berlin
- Study start
- Feb 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 1 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MS / CIS | – | – |
| Healthy controls | – | – |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected from a academic medical center MS outpatient clinic.
Key inclusion criteria (3 listed)
- Age ≥ 18 years and ≤ 85 years
- Right handed
- For patients: Diagnosis of CIS or diagnosis of MS since ≤5 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
10 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Results publication: PubMed 32307769Halbig 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.
Related trials for Multiple Sclerosis (MS)
RecruitingObservational study
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Primary Progressive Multiple Sclerosis, Primary Progressive MS
RecruitingObservational study
A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingPhase 2
A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingPhase 3
An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Friedemann Paul, MD principal investigator
Charité Unversitätsmedizin Berlin, NeuroCure Clinical Research Center NCRC
Thomas D. Hälbig, MD principal investigator
Charité Unversitätsmedizin Berlin, NeuroCure Clinical Research Center NCRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis (MS) and Clinically Isolated Syndrome (CIS), run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional modulation of motor response time (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02695394, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.