An observational study in Blepharospasm, sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-26.
Sponsored by National Institute of Neurological Disorders and Stroke (NINDS) · Observational
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 more about how eyes close in response to different stimuli. They want to study this in healthy people, people with increased blinking, and people with blepharospasm.
Objective:
To learn how light exposure affects people with blepharospasm.
Eligibility:
People ages 18 and older with blepharospasm or increased blinking, and healthy volunteers
Design:
Participants will be screened with:
Medical history
Physical exam
Neurological exam
Participants will have up to 5 visits. The number of visits will depend on the number of tests they opt to have. They can opt to have up to 4 tests. Visits last 60-90 minutes. They cannot drink alcohol or caffeinated drinks for at least 12 hours before visits. Visits could include the following tests:
Evaluation of eyelid movements. This will be video recorded.
Electromyography: Small sticky electrodes are placed on the lower eyelid skin. These are attached to wires. Muscle activity is recorded during blink reflex procedures.
Electrical stimulation: An electrode is placed close to the eyebrow. It will deliver small electrical shocks. The strength of the shocks will be enough to provoke a blink.
Photic stimulation: A lamp is placed in front of the face. It will deliver single or paired flashes. The flashes will be at various intervals and intensities. Participants will wear a patch over one eye during this test.
Combination of electrical and photic stimulation
...
Objective:
Study population:
We plan to recruit 24 patients with blepharospasm, 24 healthy volunteers (HVs) and 24 patients with increased blinking alone.
Design:
In two different studies, we will compare all the results from the EBR rc, PBR rc and MBR rc between BPS patients (first study) or increased blinking patients (second study) and HVs. We will also look for possible correlation between the neurophysiologic data and the clinical scales acquired during a clinical assessment. In the EBR rc procedure, the supraorbital nerve will be stimulated with paired electrical stimuli at varying ISIs and the EMG response from the orbicularis oculi muscles will be recorded. In the PBR rc procedure, paired light stimuli will be given at varying interstimulus intervals (ISIs) and the EMG responses from the orbicularis oculi will be recorded. In the MBR rc study a weak light stimulation will be given at varying ISIs before an electrical stimulation of the supraorbital nerve. Each experimental procedure will last about 1 hour. There will be one screening visit and up to 4 testing visits per participant. However, participant can either undergo all the experimental procedures or participate in only some of them and will be allowed to participate in two experimental procedures per testing visit.
Outcome measurements:
These results will be compared between the two patient groups and HVs. We will look for possible correlations between neurophysiological and clinical data.
42 studies on the registry are indexed under Blepharospasm; 1 is open to participants now.
This study's enrollment of 17 is below the median of 115 across 14 observational studies indexed under Blepharospasm.
Browse Blepharospasm studies →National Institute of Neurological Disorders and Stroke (NINDS) is the lead sponsor of 601 studies on the registry; 56 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
We plan to recruit 24 patients with blepharospasm, 24 healthy volunteers (HVs) and 24 patients with increased blinking alone.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For patients only: fulfill the criteria of
EXCLUSION CRITERIA:
Any of the following will exclude PATIENTS from the study:
Any of the following will exclude BOTH patients and healthy controls from the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
24 healthy volunteers (HVs)
24 patients with blepharospasm
24 patients with increased blinking alone.
Photic blink reflex recovery cycle
Time frame: Single determination
Electrocutaneous blink reflex recovery cycle; Blink rate; Light Questionnaire Scale
Time frame: Single determination
Ran from Oct 2017 to primary completion in Apr 2019, 17 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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National Institute of Neurological Disorders and Stroke (NINDS) →