Back to resultsThe Role of the Upper Colliculus in the Idiopathic Blepharospasm (COLL-BSP)
Primary Purpose
Blepharospasm, Benign Essential
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
fMRI
Sponsored by
About this trial
This is an interventional basic science trial for Blepharospasm, Benign Essential focused on measuring Superior colliculus, fMRI
Eligibility 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
Sites / Locations
- CHU Grenoble Alpes
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
idiopathic blepharospasm (BSP) de novo
Healthy subjects
Arm Description
bold signal in visual pathway
bold signal in visual pathway
Outcomes
Primary Outcome Measures
Visual pathways fMRI
To measure the bold signal in superior colliculus and lateral geniculate corpus
Secondary Outcome Measures
Full Information
NCT ID
NCT03903341
First Posted
April 2, 2019
Last Updated
September 15, 2022
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT03903341
Brief Title
The Role of the Upper Colliculus in the Idiopathic Blepharospasm
Acronym
COLL-BSP
Official Title
The Role of the Upper Colliculus in the Idiopathic Blepharospasm : a Pilot Study in Functional MRI
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
November 19, 2021 (Actual)
Study Completion Date
November 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharospasm, Benign Essential
Keywords
Superior colliculus, fMRI
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
idiopathic blepharospasm (BSP) de novo
Arm Type
Other
Arm Description
bold signal in visual pathway
Arm Title
Healthy subjects
Arm Type
Other
Arm Description
bold signal in visual pathway
Intervention Type
Other
Intervention Name(s)
fMRI
Intervention Description
bold signal in visual pathway
Primary Outcome Measure Information:
Title
Visual pathways fMRI
Description
To measure the bold signal in superior colliculus and lateral geniculate corpus
Time Frame
In a five months period after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Meoni, MD, PhD
Organizational Affiliation
CHU Grenoble Alpes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Grenoble Alpes
City
Grenoble
ZIP/Postal Code
38043
Country
France
12. IPD Sharing Statement
Learn more about this trial
The Role of the Upper Colliculus in the Idiopathic Blepharospasm
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