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Neurological and Psychiatric Comorbidities Patients With FSHD 1 and 2

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ClinicalTrials.gov Identifier: NCT02032979
Recruitment Status : Recruiting
First Posted : January 10, 2014
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

December 10, 2013
January 10, 2014
August 11, 2017
February 2014
October 2014   (Final data collection date for primary outcome measure)
  • Montgomery and Asberg Depression Rating Scale [ Time Frame: One time at the inclusion ]
  • Hamilton Depression Rating Scale [ Time Frame: One time at the inclusion ]
  • Hamilton Anxiety Rating Scale [ Time Frame: One time at the inclusion ]
  • Quick inventory of depressive symptomatology Self report [ Time Frame: One time at the inclusion ]
  • Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form [ Time Frame: One time at the inclusion ]
  • Mini Mental Status Evaluation [ Time Frame: One time at the inclusion ]
  • Wechsler Adult Intelligence Scale [ Time Frame: One time at the inclusion ]
Same as current
Complete list of historical versions of study NCT02032979 on ClinicalTrials.gov Archive Site
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Neurological and Psychiatric Comorbidities Patients With FSHD 1 and 2
Neurological and Psychiatric Comorbidities Patients With FSHD 1 and 2
The investigators propose to conduct a comparative pilot cognitive and psychiatric profiles of 10 patients Facio-Scapulo-Humeral Dystrophy (= FHSD) type 1 and 10 patients with type 2 FSHD study. For this, the investigators relied on observational components: FSHD2 patients appear more often present with psychiatric comorbidities and seem to have lower cognitive performance compared to FSHD1 patients. This was confirmed by a preliminary study on a small sample population of patients. It seems to exist mainly executive dysfunction associated with attention disorders in patients FSHD2. Moreover, their performance in IQ tests would be low in relation to their socio-educational and compared with patients FSHD1 level.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Muscular Dystrophy, Facioscapulohumeral
Behavioral: Psychiatric test
Experimental: FSHD patient
Intervention: Behavioral: Psychiatric test
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Same as current
December 2017
October 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • age ≥ 18 years and <75 years
  • FSHD patients 1 or 2 with genetic confirmation

Exclusion Criteria:

  • Phosphokinase creatine level > 5 time of the normal
  • Patient as medical history :

    • A history or active neurological disease likely to interfere with the interpretation of results
    • a history of head trauma
    • an infectious disease, hormonal, inflammatory or some deficiency may induce cognitive and / or psychiatric troubles
    • Patient with cons-indication for performing a brain MRI
  • Pregnant, parturient and lactating (producing a serum pregnancy test)
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact: Muriel LAFFON, Dr 04 92 03 82 69 ext +33 laffon.m@chu-nice.fr
France
 
 
NCT02032979
13-AOI-06
No
Not Provided
Not Provided
Centre Hospitalier Universitaire de Nice
Centre Hospitalier Universitaire de Nice
Not Provided
Not Provided
Centre Hospitalier Universitaire de Nice
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP