NCT03903341

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

November 20, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2021

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

2 years

First QC Date

April 2, 2019

Last Update Submit

September 15, 2022

Conditions

Blepharospasm, Benign Essential

Keywords

Superior colliculusfMRI

Outcome Measures

Primary Outcomes (1)

  • Visual pathways fMRI

    To measure the bold signal in superior colliculus and lateral geniculate corpus

    In a five months period after inclusion

Study Arms (2)

idiopathic blepharospasm (BSP) de novo

OTHER

bold signal in visual pathway

Other: fMRI

Healthy subjects

OTHER

bold signal in visual pathway

Other: fMRI

Interventions

fMRIOTHER

bold signal in visual pathway

Healthy subjectsidiopathic blepharospasm (BSP) de novo

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Benign essential blepharospasm

Study Officials

  • Sara Meoni, MD, PhD

    CHU Grenoble Alpes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2019

First Posted

April 4, 2019

Study Start

November 20, 2019

Primary Completion

November 19, 2021

Study Completion

November 19, 2021

Last Updated

September 16, 2022

Record last verified: 2022-09

Locations

FR(1)