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Completed

NCT Number: NCT02032979

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.

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Key information

Conditions

Muscular Dystrophy, Facioscapulohumeral Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Pasteur

Nice, 06002, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Psychiatric test

Behavioral

Primary outcomes

  1. Montgomery and Asberg Depression Rating Scale

    Time frame: One time at the inclusion

  2. Hamilton Depression Rating Scale

    Time frame: One time at the inclusion

  3. Hamilton Anxiety Rating Scale

    Time frame: One time at the inclusion

  4. Quick inventory of depressive symptomatology Self report

    Time frame: One time at the inclusion

  5. Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form

    Time frame: One time at the inclusion

  6. Mini Mental Status Evaluation

    Time frame: One time at the inclusion

  7. Wechsler Adult Intelligence Scale

    Time frame: One time at the inclusion

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 10, 2014
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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