Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040196
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2002-06-21
Brief Title:
How the Loss of Dopamine and Dopamine-Restoring Medicines Affect Movement Performance
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Dopaminergic Modulation of Cerebral Connectivity During Sequential Finger Movements
Status:
COMPLETED
Status Verified Date:
2009-07-09
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 has two purposes 1 to understand the effect of a decline of dopamine in the brain during normal aging and in patients with Parkinsons disease and 2 to investigate how medicines used to treat Parkinsons disease improve movement performance in patients
Patients with Parkinsons disease have difficulty performing precise finger movements mainly because of a dramatic decrease of a substance called dopamine in parts of the brain Medicines such as levodopa which help restore dopamine levels can greatly improve function however little is known about how these drugs work In normal aging dopamine decreases slightly in certain parts of the brain but the importance of this decline is poorly understood This study may provide new information about Parkinsons disease and normal aging that might lead to better treatment strategies
Patients with mild to moderate Parkinsons disease and healthy volunteers 21 years of age and older may be eligible for this study All participants must be right-handed All candidates will be screened with a medical history and physical and neurological examinations including memory tests and mood examination
Brain function will be studied using functional magnetic resonance imaging fMRI study and positron emission tomography PET Participants may be asked to stop using medications that can affect the central nervous system such as sleeping pills or drugs for depression or anxiety for 1 week before each study visit Patients with Parkinsons disease may also be asked to stop using antiparkinsonian medications at least 12 hours before each visit In addition all participants will be asked to abstain from alcoholic beverages at least 24 hours before the fMRI and PET scans and from nicotine and caffeine for at least 12 hours before the scans
Participants will have fMRI which uses a strong magnetic field and radio waves to create images of the brain The subject lies on a table in a tunnel-like cylinder the scanner for 1 to 2 hours lying still for 5 to 15 minutes at a time He or she can communicate with the technician or researcher at all times during the test through an intercom system Scans will be done while the subject is at rest and while he or she is performing finger movements The movements involve pushing five buttons on a box-each button every 3 seconds on average in a specific order Patients with Parkinsons disease will be studied off- and then on- medications that restore the levels of levodopa in the brain
Some participants may be asked to undergo a PET scan on a separate visit A PET scanner is a doughnut-shaped machine similar in appearance to a CT computed tomography scanner PET scans detect radioactivity used to provide information on brain activity Before the test begins subjects are given a dose of carbidopa-a medicine that increases the amount of levodopa in the brain A catheter thin plastic tube is then inserted into an arm or wrist vein and a radioactive form of levodopa called 18Fluorodopa is injected through the catheter A moldable plastic mask with large openings for eyes nose and mouth is placed on the face to help keep the head still during scanning The total scan time is 2 hours or less
Patients with Parkinsons disease have difficulty performing precise finger movements mainly because of a dramatic decrease of a substance called dopamine in parts of the brain Medicines such as levodopa which help restore dopamine levels can greatly improve function however little is known about how these drugs work In normal aging dopamine decreases slightly in certain parts of the brain but the importance of this decline is poorly understood This study may provide new information about Parkinsons disease and normal aging that might lead to better treatment strategies
Patients with mild to moderate Parkinsons disease and healthy volunteers 21 years of age and older may be eligible for this study All participants must be right-handed All candidates will be screened with a medical history and physical and neurological examinations including memory tests and mood examination
Brain function will be studied using functional magnetic resonance imaging fMRI study and positron emission tomography PET Participants may be asked to stop using medications that can affect the central nervous system such as sleeping pills or drugs for depression or anxiety for 1 week before each study visit Patients with Parkinsons disease may also be asked to stop using antiparkinsonian medications at least 12 hours before each visit In addition all participants will be asked to abstain from alcoholic beverages at least 24 hours before the fMRI and PET scans and from nicotine and caffeine for at least 12 hours before the scans
Participants will have fMRI which uses a strong magnetic field and radio waves to create images of the brain The subject lies on a table in a tunnel-like cylinder the scanner for 1 to 2 hours lying still for 5 to 15 minutes at a time He or she can communicate with the technician or researcher at all times during the test through an intercom system Scans will be done while the subject is at rest and while he or she is performing finger movements The movements involve pushing five buttons on a box-each button every 3 seconds on average in a specific order Patients with Parkinsons disease will be studied off- and then on- medications that restore the levels of levodopa in the brain
Some participants may be asked to undergo a PET scan on a separate visit A PET scanner is a doughnut-shaped machine similar in appearance to a CT computed tomography scanner PET scans detect radioactivity used to provide information on brain activity Before the test begins subjects are given a dose of carbidopa-a medicine that increases the amount of levodopa in the brain A catheter thin plastic tube is then inserted into an arm or wrist vein and a radioactive form of levodopa called 18Fluorodopa is injected through the catheter A moldable plastic mask with large openings for eyes nose and mouth is placed on the face to help keep the head still during scanning The total scan time is 2 hours or less
Detailed Description:
Objective In the central nervous system short-term plasticity can be defined as a change in connection strength that is induced by receiving presynaptic inputs Dopamine DA a neuromodulatory neurotransmitter is believed to play a role in short-term plasticity 18Fdopa positron emission tomography PET studies have shown progressive impairment of presynaptic dopaminergic DAergic function in both healthy elderly subjects HES and patients with Parkinsons disease PD Both PD and HES are characterized by a progressive decline in performance on some motor tasks and changes in activity in brain areas involved in motor control including motor control by cognitive functions as shown by functional imaging studies However little is known about the exact neurobiological mechanisms linking DAergic function brain activity and motor and cognitive performances in PD and HES In the present study we hypothesize that impaired performance on some motor tasks in those subject groups is related to a dysfunction of task-specific functional connections between areas participating in motor control In addition the brain activation with fMRI across sessions and across subjects in the healthy group will be examined to investigate the reliability of the fMRI techniques
Study population We will study two groups of participants one group of patients with mild-to-moderate PD and one group of healthy subjects
Design We will measure cerebral activity in baseline condition and during the execution of sequential finger movements using perfusion functional magnetic resonance imaging fMRI in the three subject groups The reliability of fMRI data across sessions and across subjects in the healthy young group and brain activity in patients with PD will be studied off and then on medication
Outcome measures Imaging data will be compared in terms of both regional activity and effective connectivity using the statistical parametric mapping SPM software
These experiments should lead to better understanding the pathophysiology of the mesencephalic DAergic system in human motor control and may lead to better treatment strategies in PD
Study population We will study two groups of participants one group of patients with mild-to-moderate PD and one group of healthy subjects
Design We will measure cerebral activity in baseline condition and during the execution of sequential finger movements using perfusion functional magnetic resonance imaging fMRI in the three subject groups The reliability of fMRI data across sessions and across subjects in the healthy young group and brain activity in patients with PD will be studied off and then on medication
Outcome measures Imaging data will be compared in terms of both regional activity and effective connectivity using the statistical parametric mapping SPM software
These experiments should lead to better understanding the pathophysiology of the mesencephalic DAergic system in human motor control and may lead to better treatment strategies in PD
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 |
|---|---|---|---|
| 02-N-0216 | None | None | None |