BlepharospasmNCT03263000
Photic Blink Reflex in People With Blepharospasm and Increased Blinking
An observational study of Blepharospasm, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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 more about how eyes close in response to different stimuli. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blepharospasm
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2017to 24 Apr 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We plan to recruit 24 patients with blepharospasm, 24 healthy volunteers (HVs) and 24 patients with increased blinking alone.
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Study of the Photic Blink Reflex in Patients With Blepharospasm and Increased Blinking
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.
Read more
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
...
Read the 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 feature of BPS, the electrocutaneous blink reflex recovery cycle (EBR rc) shows an increased recovery index of R2 compared with healthy subjects.
- In the first study proposed under this protocol we will study the recovery cycle of the blink reflex evoked by a light stimulus (PBR rc) and the effect of a light stimulus on the EBR (MBR rc) in patient with BPS. Since photophobia and increased blinking are common symptoms in this group of patients, we will look for possible correlations between neurophysiological data and the Light Sensitivity Questionnaire (LSQ) or the Blink rate (Brt). The second study proposed under this protocol will explore the PBR rc and the MBR rc in patients with increased blinking alone, a condition indicated as a possible precursor of BPS.
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:
- EBR rc, PBR rc, MBR rc: the electromyography (EMG) responses at different interstimulus intervals (ISIs).
- Blink rate: number of eye blinks per minute.
- LQs: the total score of the Light Questionnaire Scale.
These results will be compared between the two patient groups and HVs. We will look for possible correlations between neurophysiological and clinical data.
- Conditions
- Blepharospasm
- Keywords
- Belpharospasm, Blink Reflex, Eyeblink
- Medical subject headings
- Blepharospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | 24 healthy volunteers (HVs) | |
| Patients | 24 patients with blepharospasm | |
| Patients 2 | 24 patients with increased blinking alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photic blink reflex recovery cycle
Measured: Single determination
Secondary outcomes (1)
Electrocutaneous blink reflex recovery cycle; Blink rate; Light Questionnaire Scale
Measured: Single determination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start30 Oct 2017
- Primary completion24 Apr 2019
- Study completion24 Apr 2019
Why it stopped: Protocol could not be carried out to achieve the aims of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BlepharospasmStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark Hallett, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263000
- Sponsor's protocol ID
- 170159
- Other IDs
- 17-N-0159
- Status last verified
- Apr 2019
- First submitted
- 25 Aug 2017
- Last updated
- 26 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Adams WH, Digre KB, Patel BC, Anderson RL, Warner JE, Katz BJ. The evaluation of light sensitivity in benign essential blepharospasm. Am J Ophthalmol. 2006 Jul;142(1):82-87. doi: 10.1016/j.ajo.2006.02.020.
PubMed 16815254Albanese A, Bhatia K, Bressman SB, Delong MR, Fahn S, Fung VS, Hallett M, Jankovic J, Jinnah HA, Klein C, Lang AE, Mink JW, Teller JK. Phenomenology and classification of dystonia: a consensus update. Mov Disord. 2013 Jun 15;28(7):863-73. doi: 10.1002/mds.25475. Epub 2013 May 6.
PubMed 23649720Aramideh M, Eekhof JL, Bour LJ, Koelman JH, Speelman JD, Ongerboer de Visser BW. Electromyography and recovery of the blink reflex in involuntary eyelid closure: a comparative study. J Neurol Neurosurg Psychiatry. 1995 Jun;58(6):692-8. doi: 10.1136/jnnp.58.6.692.
PubMed 7608667
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Photic Blink Reflex in Patients With Blepharospasm and Increased Blinking
- ClinicalTrials.gov ID
- NCT03263000
- Acronym / sponsor ID
- 170159
- Conditions
- Blepharospasm
- Keywords
- Belpharospasm, Blink Reflex, Eyeblink
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Protocol could not be carried out to achieve the aims of the study
- Enrolment
- 17 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 24 Apr 2019 (actual)
- First posted
- 28 Aug 2017 (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.
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
...
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 feature of BPS, the electrocutaneous blink reflex recovery cycle (EBR rc) shows an increased recovery index of R2 compared with healthy subjects.
- In the first study proposed under this protocol we will study the recovery cycle of the blink reflex evoked by a light stimulus (PBR rc) and the effect of a light stimulus on the EBR (MBR rc) in patient with BPS. Since photophobia and increased blinking are common symptoms in this group of patients, we will look for possible correlations between neurophysiological data and the Light Sensitivity Questionnaire (LSQ) or the Blink rate (Brt). The second study proposed under this protocol will explore the PBR rc and the MBR rc in patients with increased blinking alone, a condition indicated as a possible precursor of BPS.
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:
- EBR rc, PBR rc, MBR rc: the electromyography (EMG) responses at different interstimulus intervals (ISIs).
- Blink rate: number of eye blinks per minute.
- LQs: the total score of the Light Questionnaire Scale.
These results will be compared between the two patient groups and HVs. We will look for possible correlations between neurophysiological and clinical data.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | –24 healthy volunteers (HVs) |
| Patients | – | –24 patients with blepharospasm |
| Patients 2 | – | –24 patients with increased blinking alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We plan to recruit 24 patients with blepharospasm, 24 healthy volunteers (HVs) and 24 patients with increased blinking alone.
Key inclusion criteria (7 listed)
- Must be 18 years or older
- For patients only: fulfill the criteria of
- 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.
Key exclusion criteria (16 listed)
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Photic blink reflex recovery cycle
Time frame: Single determination
1 secondary outcome
Electrocutaneous blink reflex recovery cycle; Blink rate; Light Questionnaire Scale
Time frame: Single determination
Results and safety
The study was stopped early (reason given: Protocol could not be carried out to achieve the aims of the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Background: PubMed 16815254Adams WH, Digre KB, Patel BC, Anderson RL, Warner JE, Katz BJ. The evaluation of light sensitivity in benign essential blepharospasm. Am J Ophthalmol. 2006 Jul;142(1):82-87. doi: 10.1016/j.ajo.2006.02.020.
- Background: PubMed 23649720Albanese A, Bhatia K, Bressman SB, Delong MR, Fahn S, Fung VS, Hallett M, Jankovic J, Jinnah HA, Klein C, Lang AE, Mink JW, Teller JK. Phenomenology and classification of dystonia: a consensus update. Mov Disord. 2013 Jun 15;28(7):863-73. doi: 10.1002/mds.25475. Epub 2013 May 6.
- Background: PubMed 7608667Aramideh M, Eekhof JL, Bour LJ, Koelman JH, Speelman JD, Ongerboer de Visser BW. Electromyography and recovery of the blink reflex in involuntary eyelid closure: a comparative study. J Neurol Neurosurg Psychiatry. 1995 Jun;58(6):692-8. doi: 10.1136/jnnp.58.6.692.
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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.
Mark Hallett, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blepharospasm, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
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 7 inclusion and 16 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: stopped early, as of the sponsor's last update on 26 Apr 2019. 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 United States. 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 was stopped early (reason given: Protocol could not be carried out to achieve the aims of the study). Results are not available in the source record.
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?
Photic blink reflex recovery cycle (time frame: Single determination). 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 NCT03263000, which also lists 3 linked publications.
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 26 Apr 2019.