NCT03263000

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 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 ...

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 30, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2019

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

1.5 years

First QC Date

August 25, 2017

Last Update Submit

April 25, 2019

Conditions

Blepharospasm

Keywords

BelpharospasmBlink ReflexEyeblink

Outcome Measures

Primary Outcomes (1)

  • Photic blink reflex recovery cycle

    Single determination

Secondary Outcomes (1)

  • Electrocutaneous blink reflex recovery cycle; Blink rate; Light Questionnaire Scale

    Single determination

Study Arms (3)

Healthy

24 healthy volunteers (HVs)

Patients

24 patients with blepharospasm

Patients 2

24 patients with increased blinking alone.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We plan to recruit 24 patients with blepharospasm, 24 healthy volunteers (HVs) and 24 patients with increased blinking alone.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 16815254BACKGROUND

  • Albanese 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.

    PMID: 23649720BACKGROUND

  • Aramideh 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.

    PMID: 7608667BACKGROUND

MeSH Terms

Conditions

Blepharospasm

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Study Officials

  • Mark Hallett, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2017

First Posted

August 28, 2017

Study Start

October 30, 2017

Primary Completion

April 24, 2019

Study Completion

April 24, 2019

Last Updated

April 26, 2019

Record last verified: 2019-04

Locations

US(1)