Status:
TERMINATED
Photic Blink Reflex in People With Blepharospasm and Increased Blinking
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Blepharospasm
Eligibility:
All Genders
18+ years
Brief Summary
Background: Some people who have increased blinking may later develop blepharospasm. Blepharospasm is a neurological disorder that causes involuntary closing of the eyes. Researchers want to learn mo...
Detailed Description
Objective: * The purpose of the first study of this protocol is to improve understanding of the role played by light sensitivity in the pathophysiology of blepharospasm (BPS). * As a characteristic f...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Must be 18 years or older
- For patients only: fulfill the criteria of
- Primary BPS (either focal or related to segmental dystonia) in accordance with published criteria or
- Excessive involuntary eyelid closure without sustained OO spasms in accordance with Conte et al + having a resting blink rate above 15 blinks per minute.
- Ability to give informed consent.
- Ability to comply with all study procedures.
- Agree to consume no caffeine or alcohol for 12 hours before participating in the testing visits.
- EXCLUSION CRITERIA:
- Any of the following will exclude PATIENTS from the study:
- Secondary causes of excessive involuntary eyelid closure such as ophthalmologist disorders involving the ocular surface, tear film, or eyelids.
- Any evidence suggesting a psychogenic movement disorder such as persisting unilateral or asymmetric symptoms, paroxysmal symptoms, and other inconsistencies such as pain, associated somatizations, blinking diminished by distraction, unusual sensory tricks, or unexpected response.
- Botulinum toxin treatment \< 3 months prior to a testing visit.
- History of chronic exposure (\>3 month) to dopamine receptor blocking agents before the onset of increased blinking alone or BPS.
- Any of the following will exclude BOTH patients and healthy controls from the study:
- Has any major medical problem other than increased blinking or dystonia in patient groups (such as decompensated chronic diseases or conditions that cause serious disability such as congestive heart failure/NYHA score greater than or equal to 2, severe COPD, advanced neoplasia, severe arthritis, HIV/AIDS, blindness).
- Employees, staff or fellows of HMCS in NINDS.
- Has used illegal drugs within the past 6 months based on history. The intent is to exclude those with drug use that may affect study results.
- Self-reported consumption of more than 7 alcoholic drinks a week in the case of a woman and 14 alcoholic drinks a week in the case of a man.
- Abnormal findings on neurologic exam (other than increased blinking or dystonia in patient groups).
- Presence of anatomical or functional eyelid abnormalities other than involuntary eyelid closure or OOs spasms (including apraxia of eyelid opening, and other disorders such as tics or tardive syndromes).
- Has a neurologic disorder other than increased blinking or dystonia.
- Has major depression or any major mental disorders (axis I disorders).
- Has had a head injury where there was a loss of consciousness for more than a few seconds.
- Has a deep brain stimulator, pacemaker or other implantable electronic device subject to malfunction by electrical stimulation.
Exclusion
Key Trial Info
Start Date :
October 30 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 24 2019
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03263000
Start Date
October 30 2017
End Date
April 24 2019
Last Update
April 26 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892