Neurological and Psychiatric Comorbidities Patients With FSHD 1 and 2

Muscular Dystrophy, Facioscapulohumeral Clinical Trial

Official title:

Neurological and Psychiatric Comorbidities Patients With FSHD 1 and 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02032979
• Other study ID #: 13-AOI-06
• Status: Completed
• Phase: N/A
• Start date: October 20, 2014
• Est. completion date: July 1, 2015

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 1, 2015
• Est. primary completion date: July 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Muscular Dystrophies
• Muscular Dystrophy, Facioscapulohumeral

Intervention

Behavioral:
• Psychiatric test

Locations

Country	Name	City	State
France	Hôpital Pasteur	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery and Asberg Depression Rating Scale		One time at the inclusion
Primary	Hamilton Depression Rating Scale		One time at the inclusion
Primary	Hamilton Anxiety Rating Scale		One time at the inclusion
Primary	Quick inventory of depressive symptomatology Self report		One time at the inclusion
Primary	Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form		One time at the inclusion
Primary	Mini Mental Status Evaluation		One time at the inclusion
Primary	Wechsler Adult Intelligence Scale		One time at the inclusion