Multiple SclerosisALEXCISNCT03796247
Alexithymia Frequency and Interhemispheric Transfer in Patients With a First Demyelinating Event
An observational study of Multiple Sclerosis, run by University Hospital, Lille at 1 site in France.
Trial summary
Prevalence of alexithymia in multiple sclerosis (MS) is closed to 50% but is unknown in clinically isolated syndrome (CIS).The present study sought to characterize alexithymia in CIS patients and his link between psycho behavioral and cognitive disturbances. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2011to May 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: MS patients admited in MS center of Lille after the first neurological inflammatory clinical event
Who may be able to join
- right-handed patient
- at least 1 month after steroid intake
- without severe neurological impairment
- without psychiatric disorder
Who cannot join
- patients with steroids in the last month
- patients with psychotropic drugs started in the last month
- patients with immunotherapies
- patients having contra indications for MRI
- pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alexithymia Frequency and Interhemispheric Transfer in Patients With a First Demyelinating Event: Initial Phase of Multiple Sclerosis
Prevalence of alexithymia in multiple sclerosis (MS) is closed to 50% but is unknown in clinically isolated syndrome (CIS).The present study sought to characterize alexithymia in CIS patients and his link between psycho behavioral and cognitive disturbances.
In this context, the objectives of the present study were to (a ) define the prevalence of alexithymia in CIS patients, (b ) to study this relation between psycho behavioral and cognitive disorders frequently encountered in MS.
Read the detailed description
The aim to recruit 40 CIS patients with at least two subclinical lesions on brain MRI. Patients are tested only one month at least after steroids intake and after 6 weeks at least after any relapse. The control group include 40 right -handed participants; each of them are matched for age, gender, and education level with a CIS patient.
The parameters to be evaluated are:
The prevalence of alexithymia is assessed by The Toronto Alexithymia Scale TAS-20, a self-reported scale. The TAS-20 total score corresponds to global level of alexithymia, as the sum of these three subdomains: 1.Difficulties in Identifying Feelings (DIF); 2. Difficulties in Describing Feelings (DDF); 3. Externally Oriented Thinking (EOT).
Standard neurological examination is performed by a neurologist using the Kurtzke Expanded Disability Status Scale (EDSS ).
The standardized neuropsychological battery, named BCcogSEP, is administrated. The BCcogSEP is made of eight tests commonly impaired in MS. Fourteen scores were obtained and a score was considered impaired when it was inferior to 5th percentile range compared to the normal range. The number of impaired scores are considered and a cognitive impairment is considered when 4 scores are superior or equal to percentile 5th.
For psychobehavioral assessments, the investigators estimated (a) depression (according to the Beck Depression Inventory; BDI (30)) and anxiety (according to the State-Trait Anxiety Inventory (31)); (b) apathy (according to the Lille Apathy Rating Scale (32)); (c) empathy (according to Interpersonal Reactivity Index; IRI).
- Conditions
- Multiple Sclerosis
- Keywords
- cognition, alexithymia
- Medical subject headings
- Multiple Sclerosis, Affective Symptoms
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 |
|---|---|---|
| multiple sclerosis | Not described | |
| healthy control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of alexithymia in the CIS population
alexithymia is defined according to TAS-20 (Toronto Alexithymia Scale) The Toronto Alexithymia Scale is a measure of deficiency in understanding, processing, or describing emotions. The current version has twenty statements rated on a five-point Likert scale. ( range : Strongly disagree/Disagree/ Neither agree nor disagree/ Agree/ Strongly agree)
Measured: Baseline: one session
Secondary outcomes (6)
relation between alexithymia and cognitive impairment in CIS patients and controls
cognitive functions are evaluated by the standardized neuropsychological battery, named BCcogSEP. The BCcogSEP is made of eight tests commonly impaired in MS. Fourteen scores are obtained and a score is considered impaired when it is inferior to 5th percentile range compared to the normal range. The number of impaired scores is considered and a cognitive impairment is considered when 4 scores are superior or equal to percentile 5th.
Measured: Baseline: one session
relation between alexithymia and thymic disorder in CIS and controls
Psychobehavioral assessments use the following Tools :
We estimated depression according to the Beck Depression Inventory (BDI) The BDI consisted of twenty-one questions about how the subject has been feeling in the last week. Each question had a set of at least four possible responses, ranging in intensity. (0) I do not feel sad/ (1) I feel sad./ (2) I am sad all the time and I can't snap out of it/ (3) I am so sad or unhappy that I can't stand it.
When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-off scores were as follows:0-9: indicates minimal depression/ 10-18: indicates mild depression/ 19-29: indicates moderate depression/ 30-63: indicates severe depression.
Measured: Baseline: one session
relation between alexithymia and thymic disorder in CIS and controls
Psychobehavioral assessments use the following Tools We estimated anxiety according to the State-Trait Anxiety Inventory (STAI) STAI is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis
Measured: Baseline: one session
relation between alexithymia and thymic disorder in CIS and controls
Psychobehavioral assessments use the following Tools :
We estimated apathy according to the Lille Apathy Rating Scale (LARS) The LARS is based on a structured interview. It includes 33 items, divided into nine domains. Responses are scored on a dichotomous scale
Measured: Baseline: one session
relation between alexithymia and thymic disorder in CIS and controls
Psychobehavioral assessments use the following Tools :
We estimated empathy according to Interpersonal Reactivity Index( IRI) The tool is a self-report comprising 28-items answered on a 5-point Likert scale ranging from "Does not describe me well" to "Describes me very well".
Measured: Baseline: one session
to evaluate the callosal functions and inter-hemispheric transfer in CIS and controls
dichotic listening tasks (number of sounds recognized from right or left ears) ; tactile localization recognition (number of right localization of right or left touch); letter matching test (number of right letter matching with right or left visual field) All those parameters are evaluated with qualitative assessment of functional MRI parameters
Measured: Baseline: one session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start2 May 2011
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène Zephir, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796247
- Sponsor's protocol ID
- 2010_39
- Other IDs
- 2011-A00016-35
- Acronym
- ALEXCIS
- Status last verified
- Jan 2019
- First submitted
- 3 Jan 2019
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alexithymia Frequency and Interhemispheric Transfer in Patients With a First Demyelinating Event: Initial Phase of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03796247
- Acronym / sponsor ID
- ALEXCIS / 2010_39
- Conditions
- Multiple Sclerosis
- Keywords
- cognition, alexithymia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 2 May 2011 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 8 Jan 2019 (actual)
- 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.
Prevalence of alexithymia in multiple sclerosis (MS) is closed to 50% but is unknown in clinically isolated syndrome (CIS).The present study sought to characterize alexithymia in CIS patients and his link between psycho behavioral and cognitive disturbances.
In this context, the objectives of the present study were to (a ) define the prevalence of alexithymia in CIS patients, (b ) to study this relation between psycho behavioral and cognitive disorders frequently encountered in MS.
Detailed description
The aim to recruit 40 CIS patients with at least two subclinical lesions on brain MRI. Patients are tested only one month at least after steroids intake and after 6 weeks at least after any relapse. The control group include 40 right -handed participants; each of them are matched for age, gender, and education level with a CIS patient.
The parameters to be evaluated are:
The prevalence of alexithymia is assessed by The Toronto Alexithymia Scale TAS-20, a self-reported scale. The TAS-20 total score corresponds to global level of alexithymia, as the sum of these three subdomains: 1.Difficulties in Identifying Feelings (DIF); 2. Difficulties in Describing Feelings (DDF); 3. Externally Oriented Thinking (EOT).
Standard neurological examination is performed by a neurologist using the Kurtzke Expanded Disability Status Scale (EDSS ).
The standardized neuropsychological battery, named BCcogSEP, is administrated. The BCcogSEP is made of eight tests commonly impaired in MS. Fourteen scores were obtained and a score was considered impaired when it was inferior to 5th percentile range compared to the normal range. The number of impaired scores are considered and a cognitive impairment is considered when 4 scores are superior or equal to percentile 5th.
For psychobehavioral assessments, the investigators estimated (a) depression (according to the Beck Depression Inventory; BDI (30)) and anxiety (according to the State-Trait Anxiety Inventory (31)); (b) apathy (according to the Lille Apathy Rating Scale (32)); (c) empathy (according to Interpersonal Reactivity Index; IRI).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multiple sclerosis | – | – |
| healthy control | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- MS patients admited in MS center of Lille after the first neurological inflammatory clinical event
Key inclusion criteria (4 listed)
- right-handed patient
- at least 1 month after steroid intake
- without severe neurological impairment
- without psychiatric disorder
Key exclusion criteria (5 listed)
- patients with steroids in the last month
- patients with psychotropic drugs started in the last month
- patients with immunotherapies
- patients having contra indications for MRI
- pregnancy or breast feeding
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
Frequency of alexithymia in the CIS population
Time frame: Baseline: one session
alexithymia is defined according to TAS-20 (Toronto Alexithymia Scale) The Toronto Alexithymia Scale is a measure of deficiency in understanding, processing, or describing emotions. The current version has twenty statements rated on a five-point Likert scale. ( range : Strongly disagree/Disagree/ Neither agree nor disagree/ Agree/ Strongly agree)
6 secondary outcomes
relation between alexithymia and cognitive impairment in CIS patients and controls
Time frame: Baseline: one session
relation between alexithymia and thymic disorder in CIS and controls
Time frame: Baseline: one session
relation between alexithymia and thymic disorder in CIS and controls
Time frame: Baseline: one session
relation between alexithymia and thymic disorder in CIS and controls
Time frame: Baseline: one session
relation between alexithymia and thymic disorder in CIS and controls
Time frame: Baseline: one session
to evaluate the callosal functions and inter-hemispheric transfer in CIS and controls
Time frame: Baseline: one session
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 8 Jan 2019.
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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.
Hélène Zephir, MD, PhD principal investigator
University Hospital, Lille
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, run by University Hospital, Lille at 1 site in France.
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 4 inclusion and 5 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 8 Jan 2019. 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 France. 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?
Frequency of alexithymia in the CIS population (time frame: Baseline: one session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2019.