Muscular Dystrophy, FacioscapulohumeralNCT02032979
Neurological and Psychiatric Comorbidities Patients With FSHD 1 and 2
A study testing Psychiatric test in people with Muscular Dystrophy, Facioscapulohumeral, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Muscular Dystrophy, Facioscapulohumeral
- What is being tested?
- Psychiatric test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2014to 1 Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years and <75 years
- FSHD patients 1 or 2 with genetic confirmation
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Muscular Dystrophy, Facioscapulohumeral
- Being tested
- Psychiatric test
- Medical subject headings
- Muscular Dystrophy, Facioscapulohumeral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric testBehavioural
| Study group | Role | What they receive |
|---|---|---|
| FSHD patient | Experimental | Not described Receives: Behavioral: Psychiatric test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery and Asberg Depression Rating Scale
Measured: One time at the inclusion
Hamilton Depression Rating Scale
Measured: One time at the inclusion
Hamilton Anxiety Rating Scale
Measured: One time at the inclusion
Quick inventory of depressive symptomatology Self report
Measured: One time at the inclusion
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Measured: One time at the inclusion
Mini Mental Status Evaluation
Measured: One time at the inclusion
Wechsler Adult Intelligence Scale
Measured: One time at the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study start20 Oct 2014
- Primary completion1 Jul 2015
- Study completion1 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular Dystrophy, FacioscapulohumeralStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032979
- Sponsor's protocol ID
- 13-AOI-06
- Status last verified
- Nov 2023
- First submitted
- 10 Dec 2013
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological and Psychiatric Comorbidities Patients With FSHD 1 and 2
- ClinicalTrials.gov ID
- NCT02032979
- Acronym / sponsor ID
- 13-AOI-06
- Conditions
- Muscular Dystrophy, Facioscapulohumeral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 20 Oct 2014 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 1 Jul 2015 (actual)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FSHD patient | Experimental | Behavioral: Psychiatric test |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥ 18 years and <75 years
- FSHD patients 1 or 2 with genetic confirmation
Key exclusion criteria (7 listed)
- Phosphokinase creatine level > 5 time of the normal
- Patient as medical history :
- Pregnant, parturient and lactating (producing a serum pregnancy test)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychiatric test | Behavioural | FSHD patient |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychiatric test in people with Muscular Dystrophy, Facioscapulohumeral, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery and Asberg Depression Rating Scale (time frame: One time at the inclusion). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.