Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00376753
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-09-14
Brief Title:
Muscle Contraction in Patients With Focal Hand Dystonia
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Effect of Surround Inhibition During Phasic Compared to Tonic Voluntary Finger Movement in Focal Hand Dystonia
Status:
COMPLETED
Status Verified Date:
2011-05-11
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 and compare brain activity in people with focal hand dystonia FHD and healthy volunteers to obtain further knowledge about the underlying cause of FHD Patients with dystonia have muscle spasms that cause abnormal postures while trying to perform a movement FHD affects the hands and fine finger movements During fine finger movement the brain controls muscles in a process called surround inhibition This process may be impaired in people with hand dystonia leading to uncontrolled overactivity in muscles and impairing motor function
Healthy volunteers and patients with FHD over 18 years of age may be eligible for this study Candidates are screened with a physical and neurological examination
In a series of three experiments conducted during a single clinic visit participants undergo transcranial magnetic stimulation TMS while performing a finger movement A wire coil is placed on the subjects scalp A brief electrical current is passed through the coil creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the outer part of the brain The stimulation may cause muscle hand or arm twitching or may affect movement or reflexes During the stimulation the subject is asked to contract one finger
In addition to TMS subjects have surface electromyography For this test they sit in a chair with their hands placed on a pillow on their lap The electrical activity of three muscles in the right hand is recorded by electrodes small metal disks taped to the skin over the muscles
Healthy volunteers and patients with FHD over 18 years of age may be eligible for this study Candidates are screened with a physical and neurological examination
In a series of three experiments conducted during a single clinic visit participants undergo transcranial magnetic stimulation TMS while performing a finger movement A wire coil is placed on the subjects scalp A brief electrical current is passed through the coil creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the outer part of the brain The stimulation may cause muscle hand or arm twitching or may affect movement or reflexes During the stimulation the subject is asked to contract one finger
In addition to TMS subjects have surface electromyography For this test they sit in a chair with their hands placed on a pillow on their lap The electrical activity of three muscles in the right hand is recorded by electrodes small metal disks taped to the skin over the muscles
Detailed Description:
OBJECTIVE
In sensory systems a neural mechanism called surround inhibition SI sharpens sensation by creating an inhibitory zone around the central core of activation This principle was described for the visual system first but there is evidence for similar mechanisms in the primary motor cortex M1 involved in movement generation and control especially in precise motor tasks Dystonia is generally regarded as a motor execution abnormality due to a dysfunction in the cortico-striato-thalamo-cortical motor loop Using transcranial magnetic stimulation TMS recent findings point to highly task-specific impairment of motor cortical inhibition in patients with focal hand dystonia FHD
The goal for this research proposal is to understand the underlying physiology as it relates to different inhibitory pathways on movement generation and control To achieve this goal different modes of voluntary contractions will be examined in healthy controls and patients with FHD with the prospect of having new options for treatment
STUDY POPULATION
We intend to study 100 adult patients with FHD and 100 healthy volunteers on an outpatient basis
DESIGN
Participants will perform a contraction of the first dorsal interosseous muscle FDI At rest before EMG-onset premotor during phasic and tonic contraction single TMS pulses Experiment 1 or double TMS pulses Experiment 2 will be applied over the primary motor cortex to assess activation-induced changes in cortical excitability in the abductor pollicis brevis muscle APB which is not activated Additionally the influence of visual feedback on short intracortical inhibition SICI will be tested in Experiment 3 In Experiment 4-8 interhemispheric IHI ventral and dorso-lateral premotor-motor intracortical inhibition will be assessed
OUTCOME MEASURES
The primary outcome measure for Experiment 1 will be the difference in MEP peak-to-peak amplitude between all motor conditions
The primary outcome measure for Experiment 2 5 6 7 and 8 will be the difference in normalized MEP peak-to-peak amplitude between all motor conditions in FHD patients and healthy volunteers
In Experiments 1 and 2 the change in MEP peak-to-peak amplitude between different force levels 10 versus 20 will be a second outcome parameter
The primary outcome parameter for Experiment 3 will be change in MEP peak-to-peak between patients and healthy volunteers during tonic contraction with and without visual feedback
In Experiment 4 HmaxMmax ratio will be the primary outcome parameter
In sensory systems a neural mechanism called surround inhibition SI sharpens sensation by creating an inhibitory zone around the central core of activation This principle was described for the visual system first but there is evidence for similar mechanisms in the primary motor cortex M1 involved in movement generation and control especially in precise motor tasks Dystonia is generally regarded as a motor execution abnormality due to a dysfunction in the cortico-striato-thalamo-cortical motor loop Using transcranial magnetic stimulation TMS recent findings point to highly task-specific impairment of motor cortical inhibition in patients with focal hand dystonia FHD
The goal for this research proposal is to understand the underlying physiology as it relates to different inhibitory pathways on movement generation and control To achieve this goal different modes of voluntary contractions will be examined in healthy controls and patients with FHD with the prospect of having new options for treatment
STUDY POPULATION
We intend to study 100 adult patients with FHD and 100 healthy volunteers on an outpatient basis
DESIGN
Participants will perform a contraction of the first dorsal interosseous muscle FDI At rest before EMG-onset premotor during phasic and tonic contraction single TMS pulses Experiment 1 or double TMS pulses Experiment 2 will be applied over the primary motor cortex to assess activation-induced changes in cortical excitability in the abductor pollicis brevis muscle APB which is not activated Additionally the influence of visual feedback on short intracortical inhibition SICI will be tested in Experiment 3 In Experiment 4-8 interhemispheric IHI ventral and dorso-lateral premotor-motor intracortical inhibition will be assessed
OUTCOME MEASURES
The primary outcome measure for Experiment 1 will be the difference in MEP peak-to-peak amplitude between all motor conditions
The primary outcome measure for Experiment 2 5 6 7 and 8 will be the difference in normalized MEP peak-to-peak amplitude between all motor conditions in FHD patients and healthy volunteers
In Experiments 1 and 2 the change in MEP peak-to-peak amplitude between different force levels 10 versus 20 will be a second outcome parameter
The primary outcome parameter for Experiment 3 will be change in MEP peak-to-peak between patients and healthy volunteers during tonic contraction with and without visual feedback
In Experiment 4 HmaxMmax ratio will be the primary outcome parameter
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-0242 | None | None | None |