The Role of the Upper Colliculus in the Idiopathic Blepha... | NCT03903341

Studies
The Role of the Upper Colliculus in the Idiopathic Blepharospasm

NCT03903341

Sponsor

University Hospital, Grenoble

Status

Completed

Last Update Posted

Sep 16, 2022Actual

Enrollment

13Actual

Phase

Not Applicable

Conditions

Blepharospasm, Benign Essential

Interventions

fMRI

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 20, 2019Actual

Primary Completion Date

Nov 19, 2021Actual

Completion Date

Nov 19, 2021Actual

First Submitted Date

Apr 2, 2019

First Submission Date that Met QC Criteria

Apr 2, 2019

First Posted Date

Apr 4, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2022

Last Update Posted Date

Sep 16, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
idiopathic blepharospasm (BSP) de novo	Other	bold signal in visual pathway	Other: fMRI
Healthy subjects	Other	bold signal in visual pathway	Other: fMRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fMRI	Other	bold signal in visual pathway	Healthy subjects idiopathic blepharospasm (BSP) de novo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sara Meoni, MD, PhD	CHU Grenoble Alpes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Grenoble Alpes		Grenoble		38043	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39426359	Derived	Meoni S, Dojat M, Hutchinson M, Pelissier P, Chiquet C, Moro E. Visual dysfunction of superior colliculus and lateral geniculate nucleus in idiopathic blepharospasm. J Neurol Sci. 2024 Nov 15;466:123272. doi: 10.1016/j.jns.2024.123272. Epub 2024 Oct 15.