Neurological and Psychiatric Comorbidities Patients With FSHD 1 and 2
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2013
CompletedFirst Posted
Study publicly available on registry
January 10, 2014
CompletedStudy Start
First participant enrolled
October 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedNovember 14, 2023
November 1, 2023
8 months
December 10, 2013
November 10, 2023
Conditions
Outcome Measures
Primary Outcomes (7)
Montgomery and Asberg Depression Rating Scale
One time at the inclusion
Hamilton Depression Rating Scale
One time at the inclusion
Hamilton Anxiety Rating Scale
One time at the inclusion
Quick inventory of depressive symptomatology Self report
One time at the inclusion
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
One time at the inclusion
Mini Mental Status Evaluation
One time at the inclusion
Wechsler Adult Intelligence Scale
One time at the inclusion
Study Arms (1)
FSHD patient
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- age ≥ 18 years and \<75 years
- FSHD patients 1 or 2 with genetic confirmation
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Pasteur
Nice, 06002, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2013
First Posted
January 10, 2014
Study Start
October 20, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
November 14, 2023
Record last verified: 2023-11