Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411255
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-12-12
Brief Title:
Brain Stimulation to Treat Blepharospasm or Meige Syndrome
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Blepharospasm and the Experimental Modulation of Cortical Excitability in Primary and Secondary Motor Areas A Pilot Study
Status:
COMPLETED
Status Verified Date:
2010-02-19
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 writers 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 patients 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 subjects 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
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 patients 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 subjects 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-N-0192 | None | None | None |