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Clinical Trials/NCT02032979
NCT02032979
Completed
N/A

Neurological and Psychiatric Comorbidities Patients With FSHD 1 and 2

Centre Hospitalier Universitaire de Nice1 site in 1 country6 target enrollmentOctober 20, 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Muscular Dystrophy, Facioscapulohumeral
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
6
Locations
1
Primary Endpoint
Hamilton Depression Rating Scale
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2014
End Date
July 1, 2015
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Hamilton Depression Rating Scale

Time Frame: One time at the inclusion

Hamilton Anxiety Rating Scale

Time Frame: One time at the inclusion

Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form

Time Frame: One time at the inclusion

Wechsler Adult Intelligence Scale

Time Frame: One time at the inclusion

Montgomery and Asberg Depression Rating Scale

Time Frame: One time at the inclusion

Quick inventory of depressive symptomatology Self report

Time Frame: One time at the inclusion

Mini Mental Status Evaluation

Time Frame: One time at the inclusion

Study Sites (1)

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