Blepharospasm, Benign EssentialCOLL-BSPNCT03903341
The Role of the Upper Colliculus in the Idiopathic Blepharospasm
A study testing fMRI in people with Blepharospasm, Benign Essential, run by University Hospital, Grenoble at 1 site in France.
Trial summary
This pilot study aims at investigating the role of superior colliculus in patients with idiopathic blepharospasm (BSP) de novo, compared to healthy subjects. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Blepharospasm, Benign Essential
- What is being tested?
- fMRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2019to 19 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non treated idiopathic blepharospasm
- Age: 30- 70 years
Who cannot join
- Under the following treatments: Botulin toxin, anticholinergic, benzodiazepines, baclofen, beta- and alpha-blockers collyrium
- No MRI Contraindication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Blepharospasm, Benign Essential
- Being tested
- fMRI
- Keywords
- Superior colliculus, fMRI
- Medical subject headings
- Benign essential blepharospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIOther
bold signal in visual pathway
| Study group | Role | What they receive |
|---|---|---|
| idiopathic blepharospasm (BSP) de novo | Other | bold signal in visual pathway Receives: Other: fMRI |
| Healthy subjects | Other | bold signal in visual pathway Receives: Other: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual pathways fMRI
To measure the bold signal in superior colliculus and lateral geniculate corpus
Measured: In a five months period after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start20 Nov 2019
- Primary completion19 Nov 2021
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blepharospasm, Benign EssentialStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Meoni, MD, PhD, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903341
- Sponsor's protocol ID
- 38RC17.399
- Acronym
- COLL-BSP
- Status last verified
- Sep 2022
- First submitted
- 2 Apr 2019
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39426359
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Upper Colliculus in the Idiopathic Blepharospasm : a Pilot Study in Functional MRI
- ClinicalTrials.gov ID
- NCT03903341
- Acronym / sponsor ID
- COLL-BSP / 38RC17.399
- Conditions
- Blepharospasm, Benign Essential
- Keywords
- Superior colliculus, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| idiopathic blepharospasm (BSP) de novo | Other | Other: fMRIbold signal in visual pathway |
| Healthy subjects | Other | Other: fMRIbold signal in visual pathway |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non treated idiopathic blepharospasm
- Age: 30- 70 years
Key exclusion criteria (2 listed)
- Under the following treatments: Botulin toxin, anticholinergic, benzodiazepines, baclofen, beta- and alpha-blockers collyrium
- No MRI Contraindication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRIbold signal in visual pathway | Other | Healthy subjects, idiopathic blepharospasm (BSP) de novo |
Primary outcome
Visual pathways fMRI
Time frame: In a five months period after inclusion
To measure the bold signal in superior colliculus and lateral geniculate corpus
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Derived from this study: PubMed 39426359Meoni 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Meoni, MD, PhD principal investigator
CHU Grenoble Alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI in people with Blepharospasm, Benign Essential, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual pathways fMRI (time frame: In a five months period after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03903341, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.