Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396942
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-11-07
Brief Title:
Motor Skill Learning in People With Parkinsons Disease
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of the Plasticity of the Primary Motor Cortex and Motor Learning in Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2008-10-03
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 compare brain changes in people with Parkinsons disease with those of normal control subjects while they learn motor skills People with Parkinsons disease sometimes have trouble learning new skills but it is not known why This study will use repetitive transcranial magnetic stimulation rTMS nerve conduction studies and electroencephaolography EEG to look for differences in the way the brain changes with learning in people with Parkinsons disease
Healthy normal volunteers and people with Parkinsons disease who are between 21 and 80 years of age may be eligible for this study Participants undergo the following procedures in five visits to the NIH Clinical Center
Visit 1
Medical and neurological examination
Visit 2
Motor training Participants perform a pinching movement once every other second timed to a metronome during rTMS For 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 the muscles of the face arm or leg rTMS involves repeated magnetic pulses delivered in short bursts of impulses
Visits 3 and 4
Brain physiology studies using rTMS nerve conduction studies electrical nerve stimulation and EEG A nerve at the subjects wrist is stimulated with electrical impulses to measure the speed with which nerves conduct electrical impulses and the strength of the connection between the nerve and the muscle rTMS is performed for 20 minutes The EEG measures the electrical activity of the brain brain waves For this test electrodes metal discs are placed on the scalp with a conductive gel and the brain waves are recorded while the subject moves his or her thumb briskly for 20 minutes
Visit 5
Subjects undergo rTMS for 20 minutes and have an EEG
Healthy normal volunteers and people with Parkinsons disease who are between 21 and 80 years of age may be eligible for this study Participants undergo the following procedures in five visits to the NIH Clinical Center
Visit 1
Medical and neurological examination
Visit 2
Motor training Participants perform a pinching movement once every other second timed to a metronome during rTMS For 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 the muscles of the face arm or leg rTMS involves repeated magnetic pulses delivered in short bursts of impulses
Visits 3 and 4
Brain physiology studies using rTMS nerve conduction studies electrical nerve stimulation and EEG A nerve at the subjects wrist is stimulated with electrical impulses to measure the speed with which nerves conduct electrical impulses and the strength of the connection between the nerve and the muscle rTMS is performed for 20 minutes The EEG measures the electrical activity of the brain brain waves For this test electrodes metal discs are placed on the scalp with a conductive gel and the brain waves are recorded while the subject moves his or her thumb briskly for 20 minutes
Visit 5
Subjects undergo rTMS for 20 minutes and have an EEG
Detailed Description:
Objective
The aims of the present study are to
1 Clarify that the altered plasticity of the primary motor cortex M1 in patients with Parkinsons disease PD is associated with impaired motor learning by using the paired associative stimulation PAS technique which can enhance or inhibit the M1 excitability with paired stimulation to the contralateral peripheral nerve and cerebral cortex
2 Elucidate that the altered plasticity of the M1 in patients with PD goes together with impaired sensorimotor integration via the basal ganglia-thalamocortical loop
Study population
12 right-handed patients with PD
12 right-handed age-matched healthy volunteers
Design
Patients and age-matched healthy volunteers will complete five different sessions Visit 1 clinical screening Visit 2 motor learning session Visit 3 and 4 the paired associative stimulation PAS sessions Visit 5 the control session
During the motor learning session subjects will be asked to perform metronome-paced pinch of their index finger and thumb
During the PAS sessions they will receive 20 minutes of paired stimulation to the contralateral peripheral nerve stimulation and transcranial magnetic stimulation TMS at the appropriate timing for producing changes of the M1 excitability
During the control session they will receive 20 minutes of repetitive TMS without the peripheral nerve stimulation
Outcome measures
For the motor learning session
peak acceleration MPA of thumb movement
maximal peak force MPF between the index finger and thumb
For the PAS and control sessions
peak-to-peak motor evoked potential MEP amplitude
resting motor threshold
afferent inhibition
event related desynchronization ERD and event related synchronization ERS
The aims of the present study are to
1 Clarify that the altered plasticity of the primary motor cortex M1 in patients with Parkinsons disease PD is associated with impaired motor learning by using the paired associative stimulation PAS technique which can enhance or inhibit the M1 excitability with paired stimulation to the contralateral peripheral nerve and cerebral cortex
2 Elucidate that the altered plasticity of the M1 in patients with PD goes together with impaired sensorimotor integration via the basal ganglia-thalamocortical loop
Study population
12 right-handed patients with PD
12 right-handed age-matched healthy volunteers
Design
Patients and age-matched healthy volunteers will complete five different sessions Visit 1 clinical screening Visit 2 motor learning session Visit 3 and 4 the paired associative stimulation PAS sessions Visit 5 the control session
During the motor learning session subjects will be asked to perform metronome-paced pinch of their index finger and thumb
During the PAS sessions they will receive 20 minutes of paired stimulation to the contralateral peripheral nerve stimulation and transcranial magnetic stimulation TMS at the appropriate timing for producing changes of the M1 excitability
During the control session they will receive 20 minutes of repetitive TMS without the peripheral nerve stimulation
Outcome measures
For the motor learning session
peak acceleration MPA of thumb movement
maximal peak force MPF between the index finger and thumb
For the PAS and control sessions
peak-to-peak motor evoked potential MEP amplitude
resting motor threshold
afferent inhibition
event related desynchronization ERD and event related synchronization ERS
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-0020 | None | None | None |