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NCT00411255 · ClinicalTrials.gov registry record · Phase 2

Brain Stimulation to Treat Blepharospasm or Meige Syndrome

A Phase 2 study of Focal Dystonia and Blepharospasm, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

Completed
Registry status
Phase 2
Development phase
22
Enrollment target
1
Study location

NCT00411255 is a Phase 2 study of Focal Dystonia and Blepharospasm that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 22 participants, below the 30-participant average among 8 other Focal Dystonia trials with a reported enrollment target (27% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00411255, a Phase 2 study of Focal Dystonia and Blepharospasm, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

COMPLETED
Registry status
Phase 2
Development phase
22 participants
Enrollment target
1
Study location

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 * Physi

Interventions

  • PROCEDURE repetitive transcranial magnetic stimulation (rTMS)

Study Locations (1)

Maryland

  • National Institute of Neurological Disorders and Stroke (NINDS), 9000 Rockville - Bethesda

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2006-06-22
Est. Completion 2009-04-07
Phase Phase 2

What the Registry Record Tells You About NCT00411255

The ClinicalTrials.gov registry entry for NCT00411255 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 30-participant average among 8 other Focal Dystonia trials with a reported enrollment target (27% lower). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Focal Dystonia appearing as the primary indexed condition, and to 1 intervention - of which repetitive transcranial magnetic stimulation (rTMS) is the first listed.

NCT00411255 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00411255 about?

NCT00411255 is a clinical study titled "Brain Stimulation to Treat Blepharospasm or Meige Syndrome". 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...

What is the current status of trial NCT00411255?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2006-06-22. Estimated completion is 2009-04-07.

What conditions does trial NCT00411255 study?

This clinical trial studies the following conditions: Focal Dystonia, Blepharospasm.

What interventions are being tested in trial NCT00411255?

The interventions under investigation include: repetitive transcranial magnetic stimulation (rTMS) (PROCEDURE).

Who is sponsoring clinical trial NCT00411255?

This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00411255 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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