Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500799
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2007-07-12
Brief Title:
Brain Changes in Blepharospasm
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Role of the Cortical Medial Frontal Areas in Blepharospasm
Status:
COMPLETED
Status Verified Date:
2009-04-14
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 study will examine the role of certain areas of the brain in blepharospasm a type of dystonia abnormality of movement and muscle tone that causes unwanted or uncontrollable blinking or closing of the eyelids The study will compare brain activity in healthy volunteers and in people with blepharospasm to find differences in the brain that may lead to better treatments for dystonia
Healthy volunteers and people with blepharospasm who are 18 years of age and older may be eligible for this study All candidates are screened with a medical history People with blepharospasm also have a physical examination and blepharospasm rating
Participants undergo transcranial magnetic stimulation TMS and electromyography EMG in two 4-hour sessions separated by 1 to 7 days
TMS
A wire coil is held on the subjects 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 muscles of the face arm or leg During the stimulation subjects may be asked to tense certain muscles slightly or perform other simple actions Repetitive TMS involves repeated magnetic pulses delivered in short bursts of impulses Subjects receive 60 pulses per minute over 15 minutes
EMG
Surface EMG is done during TMS to measure the electrical activity of muscles For this test electrodes small metal disks are filled with a conductive gel and taped to the skin of the face
Healthy volunteers and people with blepharospasm who are 18 years of age and older may be eligible for this study All candidates are screened with a medical history People with blepharospasm also have a physical examination and blepharospasm rating
Participants undergo transcranial magnetic stimulation TMS and electromyography EMG in two 4-hour sessions separated by 1 to 7 days
TMS
A wire coil is held on the subjects 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 muscles of the face arm or leg During the stimulation subjects may be asked to tense certain muscles slightly or perform other simple actions Repetitive TMS involves repeated magnetic pulses delivered in short bursts of impulses Subjects receive 60 pulses per minute over 15 minutes
EMG
Surface EMG is done during TMS to measure the electrical activity of muscles For this test electrodes small metal disks are filled with a conductive gel and taped to the skin of the face
Detailed Description:
Objectives
This proposal will evaluate the role of an increase in excitability of the orbicularis oculi OO muscle representation in the medial frontal areas supplementary motor areas SMA and anterior rostral cingulate M3 in excessive blinking in patients with benign essential blepharospasm BEB We hypothesize that
1 at rest the decrease of the MEP after 15 minutes of 1Hz rTMS targeting the SMA-M3 is more prominent in patients with BEP than in healthy control subjects
2 at rest the decrease of the MEP after 15 minutes of 1Hz rTMS targeting M1 is almost the same in patients with BEP and in healthy control subjects
3 at rest sICI of OO muscle will be decreased and ICF increased after stimulation of the SMA-M3 facial cortical area in patients with BEP compared to healthy control subjects
4 at rest sICI and ICF of the OO muscle will be the same after stimulation of the M1 facial area in patients with BEP and healthy control subjects
5 in healthy control subjects facilitation of the MEPs evoked from M1 is more prominent during voluntary blinking
6 in healthy control subjects facilitation of the MEP evoked from SMA-M3 is more prominent during involuntary blinking
7 in patients with BEB there is facilitation of MEPs evoked from M1 and SMA-M3 during voluntary and involuntary blinking
8 it is possible to evoke consistent and reproducible motor evoked responses MEP in the orbicularis oculi OO muscles by stimulating the two main cortical representations of upper facial region in the medial frontal wall SMA and cingulate cortex - its rostral part M3 and in the primary motor cortex M1 with transcranial magnetic stimulation TMS
Study population
36 patients with BEB but without severe forceful closure of eyelids 36 normal volunteers
Study design
Subjects will have 3 visits
Visit 1 screening and blepharospasm score
Visit 2 stimulation of the OO muscle representation in SMA-M3 using low frequency rTMS 1Hz with the Hesed coil designed to stimulate deep brain
Visit 3 stimulation of the OO muscle representation in M1 using low frequency rTMS 1Hz using a standard eight-shaped coil
Visits 2 and 3 single pulse TMS will be used to evoke MEPs from OO muscles Paired pulse TMS will be used to assess sICI from OO muscles The order of visits 2 and 3 will be randomly assigned
Outcome measures
The main outcome measures will be the sizes of OO muscle MEPs and the amount of sICI assessed before and after 15 minutes of low frequency rTMS The secondary outcome measures will be the sizes of OO muscle MEPs assessed before and during voluntary and involuntary blinks
This proposal will evaluate the role of an increase in excitability of the orbicularis oculi OO muscle representation in the medial frontal areas supplementary motor areas SMA and anterior rostral cingulate M3 in excessive blinking in patients with benign essential blepharospasm BEB We hypothesize that
1 at rest the decrease of the MEP after 15 minutes of 1Hz rTMS targeting the SMA-M3 is more prominent in patients with BEP than in healthy control subjects
2 at rest the decrease of the MEP after 15 minutes of 1Hz rTMS targeting M1 is almost the same in patients with BEP and in healthy control subjects
3 at rest sICI of OO muscle will be decreased and ICF increased after stimulation of the SMA-M3 facial cortical area in patients with BEP compared to healthy control subjects
4 at rest sICI and ICF of the OO muscle will be the same after stimulation of the M1 facial area in patients with BEP and healthy control subjects
5 in healthy control subjects facilitation of the MEPs evoked from M1 is more prominent during voluntary blinking
6 in healthy control subjects facilitation of the MEP evoked from SMA-M3 is more prominent during involuntary blinking
7 in patients with BEB there is facilitation of MEPs evoked from M1 and SMA-M3 during voluntary and involuntary blinking
8 it is possible to evoke consistent and reproducible motor evoked responses MEP in the orbicularis oculi OO muscles by stimulating the two main cortical representations of upper facial region in the medial frontal wall SMA and cingulate cortex - its rostral part M3 and in the primary motor cortex M1 with transcranial magnetic stimulation TMS
Study population
36 patients with BEB but without severe forceful closure of eyelids 36 normal volunteers
Study design
Subjects will have 3 visits
Visit 1 screening and blepharospasm score
Visit 2 stimulation of the OO muscle representation in SMA-M3 using low frequency rTMS 1Hz with the Hesed coil designed to stimulate deep brain
Visit 3 stimulation of the OO muscle representation in M1 using low frequency rTMS 1Hz using a standard eight-shaped coil
Visits 2 and 3 single pulse TMS will be used to evoke MEPs from OO muscles Paired pulse TMS will be used to assess sICI from OO muscles The order of visits 2 and 3 will be randomly assigned
Outcome measures
The main outcome measures will be the sizes of OO muscle MEPs and the amount of sICI assessed before and after 15 minutes of low frequency rTMS The secondary outcome measures will be the sizes of OO muscle MEPs assessed before and during voluntary and involuntary blinks
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 |
|---|---|---|---|
| 07-N-0191 | None | None | None |