Multiple Sclerosis in the Elderly: Epidemiology, Clinical and MRI Characteristics (OLDMUS)
Little is known about old MS patients. In a previous work, systematic search in Bordeaux, Strasbourg and Dijon university hospital regional MS center databases European Database for Multiple Sclerosis (EDMUS) retrieved 2% of 75 years old or older Multiple Sclerosis (MS) patients in the 3 databases. Data analysis showed that MS may switch off in the very old patients with mild progression and very few relapses. The project is to continue this preliminary work and extend it with a systematic study of MS in the elderly.
The scientific aims: To add new insights into long lasting MS natural history in the growing population of elderly patients with MS.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
75 to 77 years old MS patients whose disease began at 65 years old or earlier will be retrieved from the "Observatoire français de la sclérose en plaques" (OFSEP) which includes more than 50 000 MS patients in France. Accuracy of these patients' data from 65 to 75 years old will be thereafter checked and completed in 3 French MS centers: Lyon, Rennes and Bordeaux, participating to this database directly from the patients' clinical files. From these 3 MS centers around 150 MS patients from 75 to 77 years old are expected to be analysed on site.
The data wich will be retrieved for these patients are: irreversible disability status scale progression, relapses, Magnetic Resonance Imaging (MRI) data, CSF data, Lublin classification of type of MS, McDonald 2005 and 2010 criteria, date and age at beginning of progression, characteristics and modality of relapses and clinical impairment at the beginning of the disease, treatments used, treatment failures and side effects, co morbidity, Barthel index, EuroQol-5D (EQ-5D), cognitive impairment (SDMT test), social life data and socio economic data. To the investigator's knowledge this will be the first systematic description of very old MS patients with data on long term natural history of MS and characteristics in this population of elderly MS patients.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
Bordeaux, Francia
- CHU de Bordeaux - Pellegrin - service de neurologie
-
Bron, Francia
- Hôpital neurologique - Pierre Wertheimer
-
Rennes, Francia
- CHU de Rennes - service de neurologie
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Patients with McDonald 2001, 2005 or 2010 criteria of multiple sclerosis 75 to 77 years old MS patients at the time of inclusion
- Patients whose beginning of MS was before 65 years old or 65 years old
- Patients who signed OFSEP 's consent
Exclusion Criteria:
- Patients whose clinical data cannot be entered or for whom too much clinical data are missing
- Alive patients older than 77 years or younger than 75 years the day of the inclusion in the study
- Patients died before 65 years old
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
Old MS patients
75 to 77 years old MS patients whose disease began at 65 years old or earlier will be retrieved from the "Observatoire français de la sclérose en plaques" (OFSEP).
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Evaluation of MS evolution with disability progression (irreversible Disability Status Scale) in 75 to 77 years Old MS Patients from the age of 65 years-old to present time
Lasso di tempo: At inclusion (day 0)
|
Time to reach the irreversible Kurtzke disability status scale (DSS) score 4, 6 and 7
|
At inclusion (day 0)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Frequency of clinical relapses in 75 years Old or Older MS Patients from the age of 65 years-old to present time
Lasso di tempo: At inclusion (day 0)
|
At inclusion (day 0)
|
|
|
Description of the clinical characteristics at 75 years Old
Lasso di tempo: At inclusion (day 0)
|
Clinical conversion to secondary progressive MS date
|
At inclusion (day 0)
|
|
Description of the Cerebral MRI at 75 years Old
Lasso di tempo: At inclusion (day 0)
|
Number of lesions on T2 sequence if <9, number of new T2 lesions, Number of Gadolinium enhancing lesions, T1-Hypointense Lesions (T1 Black Holes), MRI Barkhof Criteria and number of periventricular lesions if <3,
|
At inclusion (day 0)
|
|
Description of the paraclinical characteristics at 75 years Old
Lasso di tempo: At inclusion (day 0)
|
Distance walked (with or without help)
|
At inclusion (day 0)
|
|
Description of the paraclinical characteristics at 75 years Old
Lasso di tempo: At inclusion (day 0)
|
Barthel index
|
At inclusion (day 0)
|
|
Socio-demographic data
Lasso di tempo: At inclusion (day 0)
|
sex
|
At inclusion (day 0)
|
|
Socio-demographic data
Lasso di tempo: At inclusion (day 0)
|
age
|
At inclusion (day 0)
|
|
Socio-demographic data
Lasso di tempo: At inclusion (day 0)
|
department of residence
|
At inclusion (day 0)
|
|
Description of the treatments at 75 years Old
Lasso di tempo: At inclusion (day 0)
|
Treatments of multiple sclerosis
|
At inclusion (day 0)
|
|
Description of the treatments at 75 years Old
Lasso di tempo: At inclusion (day 0)
|
Failures treatments of multiple sclerosis
|
At inclusion (day 0)
|
|
Description of the treatments at 75 years Old
Lasso di tempo: At inclusion (day 0)
|
Side effects of treatments and other concomitant treatments
|
At inclusion (day 0)
|
|
Measure of health-related quality of life at 75 years Old
Lasso di tempo: At inclusion (day 0)
|
EQ-5D Instruments
|
At inclusion (day 0)
|
|
Evaluation of cognitive functions at 75 years Old
Lasso di tempo: At inclusion (day 0)
|
Symbol digit modalities test (SDMT) test
|
At inclusion (day 0)
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Jean-Christophe OUALLET, MD, PhD, CHU de Bodeaux
- Cattedra di studio: Sandra VUKUSIC, Prof., Observatoire Français de la sclérose en plaques (OFSEP)
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CHUBX 2014/02
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .