Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00309010
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-03-29
Brief Title:
Neurophysiology of Task-Specificity of Focal Hand Dystonia
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Neurophysiology of Task-Specificity of Focal Hand Dystonia
Status:
COMPLETED
Status Verified Date:
2009-02-24
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 how the brain coordinates movement in patients with focal hand dystonia Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures In focal dystonia just one part of the body such as the hand neck or face is involved This study will use transcranial magnetic stimulation TMS see below to study how the brain plans movement
Healthy volunteers and patients with focal hand dystonia 18 years of age and older may be eligible for this study Healthy subjects may participate in one two or three of the experiments described below Patients with dystonia may participate in experiments one and three
Before each experiment each subject is asked about hisher medical and neurologic history complete questionnaires and will undergo a brief physical examination
Experiment 1
Surface EMG Small electrodes are taped to the skin over the arm to measure the electrical activity of muscles
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 During the stimulation the subject may be asked to tense certain muscles slightly or perform other simple actions The stimulation may cause a twitch in muscles of the face arm or leg and the subject may hear a click and feel a pulling sensation on the skin under the coil
Experiment 2 Two visits
Visit 1 Magnetic resonance imaging MRI This test uses a magnetic field and radio waves to obtain images of body tissues and organs The patient lies on a table that is moved into the scanner a metal cylinder wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process The procedure lasts about 90 minutes during which time the patient will be asked to lie still for up to 30 minutes at a time
Visit 2 Surface EMG and TMS
Experiment 3
-Surface EMG and TMS - During the TMS subjects are asked to respond to shapes on a computer screen by pushing a button or pressing a foot petal
Healthy volunteers and patients with focal hand dystonia 18 years of age and older may be eligible for this study Healthy subjects may participate in one two or three of the experiments described below Patients with dystonia may participate in experiments one and three
Before each experiment each subject is asked about hisher medical and neurologic history complete questionnaires and will undergo a brief physical examination
Experiment 1
Surface EMG Small electrodes are taped to the skin over the arm to measure the electrical activity of muscles
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 During the stimulation the subject may be asked to tense certain muscles slightly or perform other simple actions The stimulation may cause a twitch in muscles of the face arm or leg and the subject may hear a click and feel a pulling sensation on the skin under the coil
Experiment 2 Two visits
Visit 1 Magnetic resonance imaging MRI This test uses a magnetic field and radio waves to obtain images of body tissues and organs The patient lies on a table that is moved into the scanner a metal cylinder wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process The procedure lasts about 90 minutes during which time the patient will be asked to lie still for up to 30 minutes at a time
Visit 2 Surface EMG and TMS
Experiment 3
-Surface EMG and TMS - During the TMS subjects are asked to respond to shapes on a computer screen by pushing a button or pressing a foot petal
Detailed Description:
Objective
Currently there is no cure for focal hand dystonia FHD FHD research has focused predominantly on the motor execution abnormality in the primary motor cortex while the task-specific nature of FHD has received less attention Task-specificity suggests that the underlying task-to-motor output relationship is intact for many activities and dysfunctional for an important minority of tasks The premotor cortex plays a key role in this relationship in health and likely plays an equally important role in disordered movement The goal for this research proposal is to understand the underlying physiology and contribution of the premotor cortex in FHD
Study population
We intend to study adult patients with FHD and healthy volunteers on an outpatient basis In a task-specific dystonia of the hand known as writers cramp handwriting is abnormal due to posturing and muscle spasm whereas other tasks done with the affected hand are normal The disordered relationship between task-to-motor output in FHD is potentially modifiable if the correct target and therapeutic modality are identified
Design
In a series of three experiments we propose to use transcranial magnetic stimulation TMS to examine the circuitry of the premotor to motor cortex connections in FHD to interrupt motor planning in FHD and to define premotor cortex somatotopy In Experiment 1 TMS will be used to test the hypothesis that there is deficient inhibition from premotor to motor cortex in patients with FHD at rest during voluntary movement and while maintaining a task-specific position In Experiment 2 TMS will be used to identify whether there is a somatotopic organization relevant to the inhibitory premotor-motor cortex interaction in healthy volunteers In Experiment 3 to address the role of motor planning dysfunction in the task-specific nature of FHD we will use TMS to evaluate the premotor-motor cortex inhibition during a reaction time task
Outcome measures
The primary outcome measure of Experiment 1 will be change in MEP peak-to-peak amplitude between patients and healthy volunteers at rest and in two motor conditions In Experiment 2 the primary outcome measure will be the location of the TMS coil for optimizing inhibition from leg premotor cortex to motor cortex compared to the coil location from arm premotor cortex to motor cortex Finally in Experiment 3 the primary outcome measure will be the change in reaction time from baseline to the test condition with transient TMS-induced interruption in premotor cortex function
Currently there is no cure for focal hand dystonia FHD FHD research has focused predominantly on the motor execution abnormality in the primary motor cortex while the task-specific nature of FHD has received less attention Task-specificity suggests that the underlying task-to-motor output relationship is intact for many activities and dysfunctional for an important minority of tasks The premotor cortex plays a key role in this relationship in health and likely plays an equally important role in disordered movement The goal for this research proposal is to understand the underlying physiology and contribution of the premotor cortex in FHD
Study population
We intend to study adult patients with FHD and healthy volunteers on an outpatient basis In a task-specific dystonia of the hand known as writers cramp handwriting is abnormal due to posturing and muscle spasm whereas other tasks done with the affected hand are normal The disordered relationship between task-to-motor output in FHD is potentially modifiable if the correct target and therapeutic modality are identified
Design
In a series of three experiments we propose to use transcranial magnetic stimulation TMS to examine the circuitry of the premotor to motor cortex connections in FHD to interrupt motor planning in FHD and to define premotor cortex somatotopy In Experiment 1 TMS will be used to test the hypothesis that there is deficient inhibition from premotor to motor cortex in patients with FHD at rest during voluntary movement and while maintaining a task-specific position In Experiment 2 TMS will be used to identify whether there is a somatotopic organization relevant to the inhibitory premotor-motor cortex interaction in healthy volunteers In Experiment 3 to address the role of motor planning dysfunction in the task-specific nature of FHD we will use TMS to evaluate the premotor-motor cortex inhibition during a reaction time task
Outcome measures
The primary outcome measure of Experiment 1 will be change in MEP peak-to-peak amplitude between patients and healthy volunteers at rest and in two motor conditions In Experiment 2 the primary outcome measure will be the location of the TMS coil for optimizing inhibition from leg premotor cortex to motor cortex compared to the coil location from arm premotor cortex to motor cortex Finally in Experiment 3 the primary outcome measure will be the change in reaction time from baseline to the test condition with transient TMS-induced interruption in premotor cortex function
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-0126 | None | None | None |