Multiple Sclerosis, Primary ProgressivePRO-COGNCT03455582
Cognition Evolution and MRI Markers in PPMS Patients on 2 Years
A study testing Clinical assessment, Ecological evaluation and Neuropsychological evaluation in people with Multiple Sclerosis, Primary Progressive, run by University Hospital, Bordeaux at 3 sites in France.
Trial summary
Cognitive impairment is nowadays more and more recognized as an important feature of the multiple sclerosis (MS) disease. Cognitive disorders frequency in MS is estimated between 40 and 60%. Cognitive impairment affects quality of life and vocational status in MS patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Primary Progressive
- What is being tested?
- Clinical assessment, Ecological evaluation and Neuropsychological evaluation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 3 sitesFrance
- Study dates
- 24 Sep 2018to 15 Apr 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PATIENTS
- Male or female;
- Age ≥ 18 years;
- PPMS diagnosis according to McDonald 2010 criteria;
- Disease duration ≤ 15 years;
- Native French speaking;
Show all 14Show fewer
- Being affiliated to health insurance;
- Willing to participate and to sign informed consent.
- HEALTHY CONTROLS
- Male or Female;
- Age ≥ 18 years;
- Native French speaking;
- Being affiliated to health insurance;
- Willing to participate and to sign informed consent.
Who cannot join
- PATIENTS
- previous history of other neurological disease;
- psychiatric comorbidity including severe depression according to DSM-IV;
- alcohol or other addiction to toxic;
- disabling visual or motor problems preventing participation to neuropsychological assessments;
- change of psychotropic drug since less than one month;
Show all 21Show fewer
- contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body,claustrophobia or refusing MRI);
- illiteracy, is unable to count or to read;
- pregnant or breastfeeding women;
- patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).
- HEALTHY CONTROLS
- history of neurological disease;
- family history of MS;
- psychiatric comorbidity including severe depression according to DSM-IV;
- alcohol or other toxic addiction;
- psychotropic drugs; known cognitive complaint or neuropsychological affection;
- prior neuropsychological testing with the same tests less than 6 months
- contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, meta fragments or foreign objects in the eyes, skin or body, claustrophobia or refusing MRI);
- illiteracy, is unable to count or to read;
- pregnant or breastfeeding women;
- person concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Bordeaux
Bordeaux
CHU de Limoges
Limoges
CHU de Poitiers
Poitiers
About this study
Official title: Longitudinal Study of Cognition in Primary Progressive Multiple Sclerosis: a Cohort Study
Cognitive impairment is nowadays more and more recognized as an important feature of the multiple sclerosis (MS) disease. Cognitive disorders frequency in MS is estimated between 40 and 60%. Cognitive impairment affects quality of life and vocational status in MS patients.
Until recently, little information was available on the cognitive dysfunction and their evolution that occur in primary progressive multiple sclerosis (PPMS) as compared with relapsing-remitting MS (RRMS). In PPMS pathological studies have shown the importance of cortical demyelination and meningeal inflammation suggesting that the GM alteration could play a major role in the cognitive impairment in this phenotype. The cognitive evolution and the brain tissue alteration at the origin of these difficulties remain poorly understood in PPMS. The use of new techniques for morphological and functional MRI can study the contribution of diffuse White Matter (WM) alteration (probably through disconnexion of relevant network) and diffuse Grey matter (GM) alterations in the cerebral cortex and other structures (the hippocampi, the cerebellum, and the thalami) in cognitive impairment in PPMS patients and on their evolution.
- Conditions
- Multiple Sclerosis, Primary Progressive
- Being tested
- Clinical assessment, Ecological evaluation, Neuropsychological evaluation, Psychological evaluation, MRI Evaluation
- Keywords
- cognitive impairment, ecological assessment, brain MRI
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical assessmentOther
Expanded Disability Status Scale (EDSS), ambulation test and Multiple Sclerosis functional composite (MSFC). Medications will be recorded.
Ecological evaluationOther
Virtual reality task and Actual reality
Neuropsychological evaluationOther
cognitive tests exploring information processing speed, attention/concentration, working and episodic memories and executive function
Psychological evaluationOther
questionnaires for depression, anxiety and fatigue
MRI EvaluationDevice
morphological MRI and resting state functional MRI (fMRI)
| Study group | Role | What they receive |
|---|---|---|
| patient | Experimental | PPMS diagnosis according to McDonald 2010 criteria (Polman et al, 2011) Receives: Other: Clinical assessment; Other: Ecological evaluation; Other: Neuropsychological evaluation; Other: Psychological evaluation; Device: MRI Evaluation |
| Control | Active comparator | 40 Healthy controls Receives: Other: Ecological evaluation; Other: Neuropsychological evaluation; Other: Psychological evaluation; Device: MRI Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of composite z cognitive score based on individual neuropsychological scores
The composite z cognitive score is the average of z individual cognitive scores. The score from each cognitive test is transformed into z-scores. Z-scores will be calculated for each cognitive score with the following formula: (patient's score - mean value of HC group matched for age, sex, and education level)/standard deviation of the matched HC for each evaluation time (baseline and 2 years).
Individual neuropsychological scores included in composite z cognitive score : the Alertness subtest, the divided attention subtest and the visual-scanning subtest from the TAP, The Symbol-digit-modalities-test, the Paced-Auditory-Serial-Addition-Test 3s, reversed span, the Stroop test, the Verbal fluency, Trail Making test, the California Verbal memory learning test and the Brief visual memory test -revised
Measured: At baseline (day 0) and at 24 months from baseline
Secondary outcomes (3)
Correlation of composite z cognitive score and ecological score with MRI parameters reflecting grey and white matter integrity and anatomic/functional connectivity
The composite z cognitive score is the average of z individual cognitive scores. The score from each cognitive test is transformed into z-scores. Z-scores will be calculated for each cognitive score with the following formula: (patient's score - mean value of HC group matched for age, sex, and education level)/standard deviation of the matched HC for each evaluation time.
The composite z ecological score is the average of z ecological scores of virtual reality task (Urban DailyCog©) and actual reality tests.
Measured: At baseline (day 0) and at 24 months from baseline
Change of composite z cognitive score based on individual neuropsychological scores
The composite z cognitive score is the average of z individual cognitive scores. The score from each cognitive test is transformed into z-scores. Z-scores will be calculated for each cognitive score with the following formula: (patient's score - mean value of HC group matched for age, sex, and education level)/standard deviation of the matched HC for each evaluation time.
Measured: At baseline (day 0), at 12 months and at 24 months from baseline
Changes of composite z ecological score based on individual ecological scores
The composite z cognitive score is the average of z individual cognitive scores. The score from each cognitive test is transformed into z-scores. Z-scores will be calculated for each cognitive score with the following formula: (patient's score - mean value of HC group matched for age, sex, and education level)/standard deviation of the matched HC for each evaluation time. The composite z ecological score is the average of z ecological scores of virtual reality task (Urban DailyCog©) and actual reality tests.
Measured: At baseline (day 0), at 12 months and at 24 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start24 Sep 2018
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
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, Primary ProgressiveStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Aurélie RUET, Prof, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455582
- Sponsor's protocol ID
- CHUBX 2017/14
- Other IDs
- 2017-A02658-45
- Acronym
- PRO-COG
- Status last verified
- Aug 2026
- First submitted
- 4 Jan 2018
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fournet A, Munsch F, Koubiyr I, Vidal JP, Morell-Ortega S, Saubusse A, Charre-Morin J, Lataste KK, Lavielle A, Bei Z, Coupe P, Barbeau EJ, Kumar VJ, Hornberger M, Dousset V, Brochet B, Manjon JV, Ruet A, Tourdias T. Interthalamic adhesion alterations in multiple sclerosis: associations with thalamic damage and cognition. J Neurol. 2026 Aug 20;273(9):535. doi: 10.1007/s00415-026-14069-5.
PubMed 42624921
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Cognition in Primary Progressive Multiple Sclerosis: a Cohort Study
- ClinicalTrials.gov ID
- NCT03455582
- Acronym / sponsor ID
- PRO-COG / CHUBX 2017/14
- Conditions
- Multiple Sclerosis, Primary Progressive
- Keywords
- cognitive impairment, ecological assessment, brain MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 6 Mar 2018 (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.
Cognitive impairment is nowadays more and more recognized as an important feature of the multiple sclerosis (MS) disease. Cognitive disorders frequency in MS is estimated between 40 and 60%. Cognitive impairment affects quality of life and vocational status in MS patients.
Until recently, little information was available on the cognitive dysfunction and their evolution that occur in primary progressive multiple sclerosis (PPMS) as compared with relapsing-remitting MS (RRMS). In PPMS pathological studies have shown the importance of cortical demyelination and meningeal inflammation suggesting that the GM alteration could play a major role in the cognitive impairment in this phenotype. The cognitive evolution and the brain tissue alteration at the origin of these difficulties remain poorly understood in PPMS. The use of new techniques for morphological and functional MRI can study the contribution of diffuse White Matter (WM) alteration (probably through disconnexion of relevant network) and diffuse Grey matter (GM) alterations in the cerebral cortex and other structures (the hippocampi, the cerebellum, and the thalami) in cognitive impairment in PPMS patients and on their evolution.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient | Experimental | Other: Clinical assessment, Other: Ecological evaluation, Other: Neuropsychological evaluation, Other: Psychological evaluation, Device: MRI EvaluationPPMS diagnosis according to McDonald 2010 criteria (Polman et al, 2011) |
| Control | Active comparator | Other: Ecological evaluation, Other: Neuropsychological evaluation, Other: Psychological evaluation, Device: MRI Evaluation40 Healthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- PATIENTS
- Male or female;
- Age ≥ 18 years;
- PPMS diagnosis according to McDonald 2010 criteria;
- Disease duration ≤ 15 years;
Key exclusion criteria (21 listed)
- PATIENTS
- previous history of other neurological disease;
- psychiatric comorbidity including severe depression according to DSM-IV;
- alcohol or other addiction to toxic;
- disabling visual or motor problems preventing participation to neuropsychological assessments;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical assessmentExpanded Disability Status Scale (EDSS), ambulation test and Multiple Sclerosis functional composite (MSFC). Medications will be recorded. | Other | patient |
| Ecological evaluationVirtual reality task and Actual reality | Other | Control, patient |
| Neuropsychological evaluationcognitive tests exploring information processing speed, attention/concentration, working and episodic memories and executive function | Other | Control, patient |
| Psychological evaluationquestionnaires for depression, anxiety and fatigue | Other | Control, patient |
| MRI Evaluationmorphological MRI and resting state functional MRI (fMRI) | Device | Control, patient |
Primary outcome
Change of composite z cognitive score based on individual neuropsychological scores
Time frame: At baseline (day 0) and at 24 months from baseline
The composite z cognitive score is the average of z individual cognitive scores. The score from each cognitive test is transformed into z-scores. Z-scores will be calculated for each cognitive score with the following formula: (patient's score - mean value of HC group matched for age, sex, and education level)/standard deviation of the matched HC for each evaluation time (baseline and 2 years). Individual neuropsychological scores included in composite z cognitive score : the Alertness subtest, the divided attention subtest and the visual-scanning subtest from the TAP, The Symbol-digit-modalities-test, the Paced-Auditory-Serial-Addition-Test 3s, reversed span, the Stroop test, the Verbal fluency, Trail Making test, the California Verbal memory learning test and the Brief visual memory test -revised
3 secondary outcomes
Correlation of composite z cognitive score and ecological score with MRI parameters reflecting grey and white matter integrity and anatomic/functional connectivity
Time frame: At baseline (day 0) and at 24 months from baseline
Change of composite z cognitive score based on individual neuropsychological scores
Time frame: At baseline (day 0), at 12 months and at 24 months from baseline
Changes of composite z ecological score based on individual ecological scores
Time frame: At baseline (day 0), at 12 months and at 24 months from baseline
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 4 Aug 2026.
- Derived from this study: PubMed 42624921Fournet A, Munsch F, Koubiyr I, Vidal JP, Morell-Ortega S, Saubusse A, Charre-Morin J, Lataste KK, Lavielle A, Bei Z, Coupe P, Barbeau EJ, Kumar VJ, Hornberger M, Dousset V, Brochet B, Manjon JV, Ruet A, Tourdias T. Interthalamic adhesion alterations in multiple sclerosis: associations with thalamic damage and cognition. J Neurol. 2026 Aug 20;273(9):535. doi: 10.1007/s00415-026-14069-5.
Related trials for Multiple Sclerosis, Primary Progressive
RecruitingPhase 1
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
B-cell Mediated Autoimmune Disorders
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Multiple Sclerosis (MS) Primary Progressive
RecruitingObservational study
REAL-MS: Observational Database Study of AHSCT and MS Therapies
Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting
Not yet recruitingPhase 1/2
C-CAR168, an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cell Therapy, in Participants With Progressive Multiple Sclerosis Refractory to Standard Therapy
Multiple Sclerosis, Primary Progressive Multiple Sclerosis
RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
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.
Aurélie RUET, Prof principal investigator
University Hospital, Bordeaux
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical assessment, Ecological evaluation and Neuropsychological evaluation in people with Multiple Sclerosis, Primary Progressive, run by University Hospital, Bordeaux at 3 sites 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 14 inclusion and 21 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 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Change of composite z cognitive score based on individual neuropsychological scores (time frame: At baseline (day 0) and at 24 months from baseline). 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 NCT03455582, 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 4 Aug 2026.