NCT00411255

Brain Stimulation to Treat Blepharospasm or Meige Syndrome

Completed Phase 2 Last updated 2 July 2017

What this trial tests

Phase 2 trial testing repetitive transcranial magnetic stimulation (rTMS) in Blepharospasm in 22 participants. Completed in 7 April 2009.

Timeline

22 June 2006

Primary endpoint
7 April 2009

7 April 2009

Quick facts

Lead sponsor	National Institute of Neurological Disorders and Stroke (NINDS)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Design	crossover
Masking	single
Primary purpose	supportive care
Enrollment	22
Start date	22 June 2006
Primary completion	7 April 2009
Estimated completion	7 April 2009
Sites	1 location across United States

Drugs / interventions tested

• repetitive transcranial magnetic stimulation (rTMS)

Conditions studied

• Blepharospasm — all drugs for Blepharospasm →
• Focal Dystonia — all drugs for Focal Dystonia →

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Who can join

18 and older, any sex, with Blepharospasm or Focal Dystonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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...

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.