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

• Sponsor: University Hospital, Grenoble (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03903341
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 50.4
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Blepharospasm, Benign Essential	Other: fMRI	N/A

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 Design

• Study Type: Interventional
• Anticipated 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: Nov 20, 2019
• Anticipated Primary Completion Date: Feb 1, 2024
• Anticipated Study Completion Date: Feb 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Visual pathways fMRI [In a five months period after inclusion]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Grenoble Alpes	Grenoble		France	38043

Sponsors and Collaborators

• University Hospital, Grenoble

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Grenoble
• ClinicalTrials.gov Identifier: NCT03903341
• Other Study ID Numbers: 38RC17.399
• First Posted: Apr 4, 2019
• Last Update Posted: Feb 4, 2022
• Last Verified: Feb 1, 2022

• 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: Blepharospasm

Study Results

No Results Posted as of Feb 4, 2022