Neurological and Psychiatric Comorbidities Patients With FSHD 1 and 2

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02032979

Enrollment

Registered

2014-01-10

Start date

2014-10-20

Completion date

2015-07-01

Last updated

2023-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscular Dystrophy, Facioscapulohumeral

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.

Interventions

BEHAVIORALPsychiatric test

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026