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TerminatedNCT00763191Updated Dec 10, 2012

Analysis of Oculo-motor Deficiencies Associated With FMR1 Gene Expression (Genetic Abnormality Predisposing to a Neurodegenerative Disease)

An interventional study of examination of ocular movements and MATTIS test in Pre-mutation on FMR1 Gene, sponsored by Nantes University Hospital. Terminated at 1 site in France. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2012-12-10.

Sponsored by Nantes University Hospital · Not applicable, Interventional, and Health services research

Why this study was terminated
departure of the principal investigator and nobody else was able to continue this study.
Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

The specific aim of this study is to compare ocular movements abnormalities between males with pre-mutation on FRM1 gene (symptomatic or asymptomatic on the motor plan and/or on the cognitive plan), males without the pre-mutation and males with multi-systematized atrophy, in order to identify the neuronal structures implicated in this pathology.

Read the detailed description

Patient will be followed at the Nantes hospital during half a day for :

  • examination of ocular movements
  • performing Neuro-psychological test (MATTIS)
  • performing tests with scales of motricity (UPDRS, CRST, ICARS).
02

Conditions studied

  • Pre-mutation on FMR1 Gene
03

In context

Neurodegenerative Diseases

370 studies on the registry are indexed under Neurodegenerative Diseases; 145 are open to participants now.

This study's enrollment of 27 is below the median of 53 across 204 interventional studies indexed under Neurodegenerative Diseases.

Browse Neurodegenerative Diseases studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

FOR PATIENTS WITH PREMUTATION ON FMR1 GENE (30 patients expected):

Inclusion criteria:

  • Male
  • > or equal to 50 years old
  • Ally second or third degree with a child affected of "fragile X"
  • Not living far from Nantes so that visits to the Nantes hospital can be easy
  • Pre-mutation on FMR1 gene
  • Signed informed consent

Exclusion criteria:

  • Female
  • \<50 years old
  • visual acuteness \< 1/10
  • MATTIS dementia scale \<100 (normal:144)
  • Occurrence, shown by MRI (Magnetic Resonance Imaging), of a pathology either ischemic vascular or hemorrhagic or tumoral

FOR PATIENTS WITHOUT PRE-MUTATION ON FMR1 GENE (10 patients expected):

Inclusion criteria:

  • Male
  • > or equal to 50 years old
  • Ally second or third degree with a child affected of "fragile X"
  • Not living far from Nantes so that visits to the Nantes hospital can be easy - Signed informed consent

Exclusion criteria:

  • Female
  • \<50 years old
  • visual acuteness \< 1/10
  • MATTIS dementia scale \<100 (normal:144)
  • Pre-mutation on FMR1 gene
  • Occurrence, shown by MRI, of a pathology either ischemic vascular or hemorrhagic or tumoral

FOR PATIENTS WITH MULTI-SYSTEMATIZED ATROPHY (10 patients expected):

Inclusion criteria:

  • Male
  • > or equal to 50 years old
  • Not living far from Nantes so that visits to the Nantes hospital can be easy
  • "probable" diagnosis of multi-systematized atrophy
  • Signed informed consent

Exclusion Criteria:

  • Female
  • \<50 years old
  • visual acuteness \< 1/10
  • MATTIS dementia scale \<100 (normal:144)
  • Occurrence, shown by MRI, of a pathology either ischemic vascular or hemorrhagic or tumoral
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (actual)

Interventions

  • Otherexamination of ocular movements
  • OtherMATTIS test
  • OtherUPDRS test
  • OtherCRST test
06

What researchers measure

Primary outcomes

  1. Comparison of the oculo-motricity of patients with FMR1 pre-mutation with the oculo-motricity of patients without FMR1 pre-mutation

Secondary outcomes

  1. Comparison of the oculo-motricity of patients with FMR1 pre-mutation with the oculo-motricity of patients with multi-systematized atrophy

  2. Analysis of the correlation between the genotype (number of CGG repetition) and the phenotype.

  3. For subjects with FMR1 pre-mutation, comparison of the neuro-psychological test results to the oculo-motor abnormalities.

07

Study locations

1 site
  • Laennec hospital, university hospital of Nantes
    Nantes, 44093, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00763191
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Sep 30, 2008
Start date
Jun 2008
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Dec 10, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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