Brain Stimulation to Treat Blepharospasm or Meige Syndrome
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2006 |
| End Date: | April 2009 |
Blepharospasm and the Experimental Modulation of Cortical Excitability in Primary and Secondary Motor Areas. A Pilot Study.
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...
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...
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.
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.
- 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 childbearing potential.
- Symptoms of a clinically relevant 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.
We found this trial at
1
site
Bethesda, Maryland 20892
Click here to add this to my saved trials
