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CompletedNCT00411255Updated Jul 2, 2017

Brain Stimulation to Treat Blepharospasm or Meige Syndrome

A Phase 2 interventional study of repetitive transcranial magnetic stimulation (rTMS) in Blepharospasm and Focal Dystonia, sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-02.

Sponsored by National Institute of Neurological Disorders and Stroke (NINDS) · Phase 2, Interventional, and Supportive care

Phase
Phase 2
Study type
Interventional
Enrollment
22
Ages
18 Years and older
Sex
All
01

Study summary

This research study will examine whether magnetic or electrical stimulation of the brain can improve the involuntary closure of the eyelids in patients with blepharospasm or Meige syndrome; conditions that belong to a group of neurological disorders called dystonias. Blepharospasm and Meige syndrome cause excessive involuntary closure of the eyelids or blinking. In an earlier study of patients with writer's cramp, which is another form of dystonia, symptoms improved temporarily with brain stimulation.

Interested people 18 years of age or older with blepharospasm or Meige syndrome may be eligible for this study. Candidates are screened with a medical history, physical examination and a blink reflex test.

Participants undergo brain stimulation and evaluations before and after the stimulation to test the response, as follows:

Procedures

  • Transcranial magnetic stimulation (TMS): A wire coil is held on the patient's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in the muscles of the face, arm or leg. The subject may be asked to tense certain muscles slightly or perform other simple actions. The effect of TMS on the muscles is detected with small metal disk electrodes taped to the skin of the arms or legs. TMS is done on eight of the ten test days.
  • Repetitive TMS (rTMS): The same procedure as TMS, except repeated magnetic pulses are delivered in short bursts. RTMS is done on eight of the ten test days.
  • Theta burst stimulation (TBS): A form of rTMS that involves short bursts of impulses. TBS is done on four study days.
  • Cathodal transcranial DC stimulation (tDCS): Two conductive-rubber electrodes placed in saline-soaked sponges are positioned over two areas of the head. A constant weak electrical current flow is applied for 20 minutes. tDCS is done on two study days.

Evaluations

  • Physician observation: The subject's eyes are videotaped for 5 minutes before and after each TMS session. A physician then counts how many times the subject blinked during the 5 minutes.
  • Questionnaire: Subjects are asked to rate their symptoms before and after brain stimulation.
  • Electrophysiological test of the blink reflex: Wires are taped to the skin on the nose and temple to record the eye movement during blinking. A thin plastic rod is placed on the skin over the right e...
Read the detailed description

BACKGROUND: Blepharospasm (BSP) is a common form of focal dystonia, but the etiology and underlying pathophysiological mechanisms are still obscure. BSP is characterized by excessive involuntary closure of the eyelids. Pathological changes in excitability in the primary motor cortex (MC) and secondary motor areas, such as the anterior cingulate (AC), pre-and supplementary cortex (PMC, SMA) are suggested from electrophysiological and brain imaging studies. It is conceivable that modulation of excitability in some of these areas may lead to amelioration of the symptoms of BSP. Cortical excitability can be experimentally changed by various well-established electrophysiological techniques non-invasively.

METHODS: In this pilot protocol, studying 30 patients with BSP, we will use repetitive transcranial magnetic stimulation (rTMS) over the AC, PMC, SMA and MC in two different inhibitory modes: low frequency rTMS ((lf) rTMS) and continuous theta burst stimulation cTBS. Furthermore, we will apply transcranial direct stimulation (tDCS) in an inhibitory mode (cathodal tDCS) over the MC and low intensity high frequency supraorbital electrical stimulation; the latter will be performed in patients and in 7 healthy subjects. The effects on blepharospasm will be objectively measured by electrophysiological measures (blink reflex recovery curve (BRR), blink rate observation by an investigator blinded to the intervention, and a subjective rating by the patient.

OBJECTIVES: We hypothesize that we will find variable amounts of clinical improvement in BSP patients with these different methods. With this study, we aim to get more insight to the underlying pathophysiological mechanisms of BSP and identify which method of non-invasive brain stimulation may be clinically most efficacious.

02

Conditions studied

  • Blepharospasm
  • Focal Dystonia

Keywords

  • Blink Reflex
  • Transcranial Magnetic Stimulation (TMS)
  • Dystonia
  • Blepharospasm
  • BSP
  • Focal Dystonia
03

In context

Blepharospasm

42 studies on the registry are indexed under Blepharospasm; 1 is open to participants now.

This study's enrollment of 22 is below the median of 40 across 28 interventional studies indexed under Blepharospasm.

Browse Blepharospasm studies →

Lead sponsor

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.

Browse National Institute of Neurological Disorders and Stroke (NINDS) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

  • INCLUSION CRITERIA PATIENTS:
  • Patients with idiopathic BSP or Meige-Syndrome (=BSP plus oromandibular dystonia).
  • Age 18 years or older.
  • Normal findings in the medical history, physical and neurological examination, except for dystonia (in cases that patients have not had an H\& P at the NIH within the last 12 months; they will undergo all these exams on the first study day).
  • Last treatment with botulinum toxin more than three months ago.

INCLUSION CRITERIA CONTROLS:

  • Age 18 years or older
  • Normal findings in the medical history, physical and neurological examination
  • No history of neuroleptic medications/ prior use of neuroleptics (such as Haldol(Registered Trademark))
  • Not been treated or taken anti-depressants, anti-seizure medication, anticholinergic drugs (such as Artane(Registered Trademark)) and muscle relaxants within the past 4 weeks

EXCLUSION CRITERIA PATIENTS:

Any of the following will exclude a patient from the study:

  • Other disease with involuntary blinking (Hemifacial spasm, Tic disorder, Tardive Dyskinesia, Tardive dystonia, etc).
  • BSP and normal recovery of R2 in BRR.
  • Participation in a clinical trial in the 2 weeks preceding the study.
  • History of seizure disorder.
  • Pregnancy- a pregnancy test will be performed for women of .
  • Symptoms of a illness in the 4 weeks before the first study day, including history of any other neurological disorders or conditions requiring the use of anti-depressants, neuroleptic medications or anti-seizure meds., anticholinergic drugs and muscle relaxants.
  • History of neuroleptic medications/prior use of neuroleptics.

EXCLUSION CRITERIA CONTROLS:

A botulinum toxin injection within 3 months of starting the protocol

Any condition that requires the use of anti-depressants, anti-psychotic or anti-seizure medications

Cannot follow the instruction through the entire recording

Not able to provide consent to participate in the study

Patients will be screened and recruited from the outpatient clinic of the HMCS, NINDS. Age matched volunteers will be recruited from the NIH Patient Recruitment and Public Liaison Office.

Terms in these criteria, in plain language(2)

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Supportive care
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
22 participants (actual)

Interventions

  • Procedurerepetitive transcranial magnetic stimulation (rTMS)

    Three arms on three different days 180 stimuli will be delivered to the AC with a sham coil, with the H-coil and with a standard circular coil in separate sessions.

06

What researchers measure

Secondary outcomes

  1. Patient report the subject rating of their symptoms before and after intervention.

    Time frame: Before, immediately after, and one hour after the intervention.

07

Study locations

1 site
  • National Institute of Neurological Disorders and Stroke (NINDS), 9000 Rockville
    Bethesda, Maryland 20892, United States
08

References and documents

Publications

  • Antal A, Kincses TZ, Nitsche MA, Bartfai O, Paulus W. Excitability changes induced in the human primary visual cortex by transcranial direct current stimulation: direct electrophysiological evidence. Invest Ophthalmol Vis Sci. 2004 Feb;45(2):702-7. doi: 10.1167/iovs.03-0688. PubMed 14744917 ↗
  • Aramideh M, Koelman JH, Speelman JD, Ongerboer de Visser B. Eyelid movement disorders and electromyography. Lancet. 2001 Mar 10;357(9258):805-6. doi: 10.1016/s0140-6736(05)71235-6. No abstract available. PubMed 11254003 ↗
  • 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. Erratum In: J Neurol Neurosurg Psychiatry 1995 Dec;59(6):662. PubMed 7608667 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2006, a primary completion of Apr 2009 and a completion of Apr 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 12, 2006
First posted
Dec 13, 2006
Start
Jun 22, 2006
Primary completionActual
Apr 7, 2009
CompletionActual
Apr 7, 2009
Last update
Jul 2, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00411255
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
First posted
Dec 13, 2006
Start date
Jun 22, 2006
Primary completion
Apr 7, 2009
Completion
Apr 7, 2009
Last update
Jul 2, 2017
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

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