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Neurological and Psychiatric Comorbidities Patients With FSHD 1 and 2

This study is currently recruiting participants.
Verified August 2017 by Centre Hospitalier Universitaire de Nice
Sponsor:
ClinicalTrials.gov Identifier:
NCT02032979
First Posted: January 10, 2014
Last Update Posted: August 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
  Purpose
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.

Condition Intervention
Muscular Dystrophy, Facioscapulohumeral Behavioral: Psychiatric test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Neurological and Psychiatric Comorbidities Patients With FSHD 1 and 2

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Actual Study Start Date: February 2014
Estimated Study Completion Date: December 2017
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FSHD patient Behavioral: Psychiatric test

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032979


Contacts
Contact: Muriel LAFFON, Dr 04 92 03 82 69 ext +33 laffon.m@chu-nice.fr

Locations
France
Hôpital Pasteur Recruiting
Nice, France, 06002
Contact: Muriel LAFFON, Dr    04 92 03 82 69 ext +33    laffon.m@chu-nice.fr   
Principal Investigator: Muriel LAFFON, Dr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02032979     History of Changes
Other Study ID Numbers: 13-AOI-06
First Submitted: December 10, 2013
First Posted: January 10, 2014
Last Update Posted: August 11, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Facioscapulohumeral
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn