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

September 15, 2022 updated by: University Hospital, Grenoble

The Role of the Upper Colliculus in the Idiopathic Blepharospasm : a Pilot Study in Functional MRI

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • Chu Grenoble Alpes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: idiopathic blepharospasm (BSP) de novo
bold signal in visual pathway
Other: fMRI
bold signal in visual pathway
Other: Healthy subjects
bold signal in visual pathway
Other: fMRI
bold signal in visual pathway

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual pathways fMRI
Time Frame: In a five months period after inclusion
To measure the bold signal in superior colliculus and lateral geniculate corpus
In a five months period after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Sara Meoni, MD, PhD, Chu Grenoble Alpes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2019

Primary Completion (Actual)

November 19, 2021

Study Completion (Actual)

November 19, 2021

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

April 2, 2019

First Posted (Actual)

April 4, 2019

Study Record Updates

Last Update Posted (Actual)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 15, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC17.399

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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