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The Role of the Upper Colliculus in the Idiopathic Blepharospasm (COLL-BSP)

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ClinicalTrials.gov Identifier: NCT03903341
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
This pilot study aims at investigating the role of superior colliculus in patients with idiopathic blepharospasm (BSP) de novo, compared to healthy subjects.

Condition or disease Intervention/treatment Phase
Blepharospasm, Benign Essential Other: fMRI Not Applicable

Detailed Description:
The objective of the study is to investigate the function of the superior colliculus (SC) related to visual stimulation by means of fMRI (functional magnetic resonance imaging) in patients with idiopathic BSP compared to healthy subjects. The hypothesis is that SC function is impaired in BSP (role of biomarker of SC).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Role of the Upper Colliculus in the Idiopathic Blepharospasm : a Pilot Study in Functional MRI
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : August 2021


Arm Intervention/treatment
idiopathic blepharospasm (BSP) de novo
bold signal in visual pathway
Other: fMRI
bold signal in visual pathway

Healthy subjects
bold signal in visual pathway
Other: fMRI
bold signal in visual pathway




Primary Outcome Measures :
  1. Visual pathways fMRI [ Time Frame: In a five months period after inclusion ]
    To measure the bold signal in superior colliculus and lateral geniculate corpus



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non treated idiopathic blepharospasm
  • Age: 30- 70 years

Exclusion Criteria:

  • Under the following treatments: Botulin toxin, anticholinergic, benzodiazepines, baclofen, beta- and alpha-blockers collyrium
  • No MRI Contraindication

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): NCT03903341


Contacts
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Contact: Sara Meoni, MD, PhD + 33 4 76 76 94 52 smeoni@chu-grenoble.fr

Locations
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France
CHU Grenoble Alpes Recruiting
Grenoble, France, 38043
Contact: Pierre Pelissier, Master    + 3 4 76 76 94 59    ppelissier@chu-grenoble.fr   
Sub-Investigator: Elena Moro, MD-PhD         
Sub-Investigator: Valérie Fraix, MD-PhD         
Sub-Investigator: Anna Castrioto, MD-PhD         
Sub-Investigator: Marie Fournier, MD         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Sara Meoni, MD, PhD chu gRENOBLE aLPES

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03903341     History of Changes
Other Study ID Numbers: 38RC17.399
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
Superior colliculus
fMRI
Additional relevant MeSH terms:
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Blepharospasm
Eyelid Diseases
Eye Diseases