Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00067275
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2003-08-13
Brief Title:
The Effect of Dopamine on Motor Skills Training
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Dopamine Release in Use-Dependent Plasticity in Health and Disease
Status:
COMPLETED
Status Verified Date:
2007-08-15
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 dopamine a brain chemical affects motor training Taken by mouth dopamine can enhance motor training especially during rehabilitation after brain damage The study will also examine whether Sinemet a drug containing a precursor of dopamine can improve motor training
Healthy normal volunteers and stroke patients between 18 and 80 years of age may be eligible for this study Healthy volunteers must be right-handed Stroke patients must have had a stroke that caused weakness in one hand from which they have recovered enough to be able to move the thumb in different directions Participants will have up to three study sessions as follows
Prestudy 1 MRI TMS with motor training
Session 1 Magnetic resonance imaging MRI of the brain This procedure uses a strong magnetic field and radio waves to show structural and chemical changes in tissues During the scan the patient lies on a table in a narrow cylinder containing a magnetic field He or she can communicate with the staff administering the test at all times
Session 2 Transcranial magnetic stimulation TMS - The subject sits in a comfortable chair with the right forearm held still at the side and the head held still by an aluminum frame A magnetic coil is placed over the head and a small probe is attached to the thumb to measure thumb movement Magnetic pulses are occasionally delivered over the scalp likely inducing a mild thumb movement After this test the subject takes a tablet of either Sinemet or placebo a look-alike pill with no active ingredient Fifty minutes after taking the pill the subject undergoes motor training that involves performing brisk thumb movements at a rate of 1 movement per second At the end of the training TMS is repeated
Session 3 Identical to session 2 except subjects who took Sinemet in session 2 now take placebo and vice versa
Prestudy 2 MRI PET without motor training no TMS
Session 1 MRI of the brain if the subject has not had one within the last 12 months
Session 2 Positron emission tomography PET scanning - This procedure provides information on brain chemistry and function First the subject is given either Sinemet or placebo The subject lies on a bed in a doughnut-shaped machine with a custom-molded plastic mask placed over the face and head to support the head and hold it still during the scanning A catheter plastic tube is placed in each arm-one to inject 11Craclopride-a radioactive substance that competes with dopamine for binding in certain parts of the brain and can be detected by the PET scanner-and one to draw blood samples for measuring the level of Sinemet in the blood
Session 3 Identical to session 2 except subjects who took Sinemet in session 2 now take placebo and vice versa
Main Study MRI TMS PET with motor training
Session 1 MRI of the brain if one has not been done within the last 12 months
Session 2 TMS followed by administration of Sinemet or placebo and PET scanning with motor training The subject lies quietly during the first half of the PET session and performs brisk thumb movements during the second half After completing the PET scan the subject undergoes TMS again
Session 3 Identical to session 2 except subjects who took Sinemet in session 2 now take placebo and vice versa
Healthy normal volunteers and stroke patients between 18 and 80 years of age may be eligible for this study Healthy volunteers must be right-handed Stroke patients must have had a stroke that caused weakness in one hand from which they have recovered enough to be able to move the thumb in different directions Participants will have up to three study sessions as follows
Prestudy 1 MRI TMS with motor training
Session 1 Magnetic resonance imaging MRI of the brain This procedure uses a strong magnetic field and radio waves to show structural and chemical changes in tissues During the scan the patient lies on a table in a narrow cylinder containing a magnetic field He or she can communicate with the staff administering the test at all times
Session 2 Transcranial magnetic stimulation TMS - The subject sits in a comfortable chair with the right forearm held still at the side and the head held still by an aluminum frame A magnetic coil is placed over the head and a small probe is attached to the thumb to measure thumb movement Magnetic pulses are occasionally delivered over the scalp likely inducing a mild thumb movement After this test the subject takes a tablet of either Sinemet or placebo a look-alike pill with no active ingredient Fifty minutes after taking the pill the subject undergoes motor training that involves performing brisk thumb movements at a rate of 1 movement per second At the end of the training TMS is repeated
Session 3 Identical to session 2 except subjects who took Sinemet in session 2 now take placebo and vice versa
Prestudy 2 MRI PET without motor training no TMS
Session 1 MRI of the brain if the subject has not had one within the last 12 months
Session 2 Positron emission tomography PET scanning - This procedure provides information on brain chemistry and function First the subject is given either Sinemet or placebo The subject lies on a bed in a doughnut-shaped machine with a custom-molded plastic mask placed over the face and head to support the head and hold it still during the scanning A catheter plastic tube is placed in each arm-one to inject 11Craclopride-a radioactive substance that competes with dopamine for binding in certain parts of the brain and can be detected by the PET scanner-and one to draw blood samples for measuring the level of Sinemet in the blood
Session 3 Identical to session 2 except subjects who took Sinemet in session 2 now take placebo and vice versa
Main Study MRI TMS PET with motor training
Session 1 MRI of the brain if one has not been done within the last 12 months
Session 2 TMS followed by administration of Sinemet or placebo and PET scanning with motor training The subject lies quietly during the first half of the PET session and performs brisk thumb movements during the second half After completing the PET scan the subject undergoes TMS again
Session 3 Identical to session 2 except subjects who took Sinemet in session 2 now take placebo and vice versa
Detailed Description:
It has been proposed that the nigrostriatal and cortical dopaminergic systems are involved in motor learning in health and disease However it is not known to which extent dopamine influences use-dependent plasticity UDP one of the crucial functions that mediate recovery of motor function after stroke Understanding the role of dopamine on UDP in healthy volunteers and patients with stroke may impact the development of rationale strategies to promote functional recovery after this condition
The aim of the present protocol is to provide evidence for the influence of dopaminergic function on UDP in health and disease We plan to address this issue in two different complementary ways main experiment a determine if UDP is positively correlated with the decrease in raclopride binding potential RAC-BP in the contralateral dorsal striatum primary outcome measure and b determine if administration of a dopaminergic drug will enhance UDP and elicit a decrease in RAC-BP in the contralateral dorsal striatum
Before the main experiment we will assess the ability of a dopaminergic drug to enhance UDP prestudy 1 motor training only and the effects of a dopaminergic drug on RAC-BP during resting condition prestudy 2 RAC-PET during resting condition only
UDP will be assessed using a technique developed in our lab in which we have extensive experience In short we will evaluate TMS-evoked thumb movement directions after a period of motor training consisting of performance of voluntary thumb movements for 30 minutes Striatal and cortical dopamine release will be assessed with positron emission tomography using the dopamine-D2 receptor radioligand 11Craclopride after administration of placebo and after administration of a dopaminergic drug The study will be initially done in a group of healthy volunteers and then in a group of patients with chronic subcortical stroke who experienced good motor recovery
The aim of the present protocol is to provide evidence for the influence of dopaminergic function on UDP in health and disease We plan to address this issue in two different complementary ways main experiment a determine if UDP is positively correlated with the decrease in raclopride binding potential RAC-BP in the contralateral dorsal striatum primary outcome measure and b determine if administration of a dopaminergic drug will enhance UDP and elicit a decrease in RAC-BP in the contralateral dorsal striatum
Before the main experiment we will assess the ability of a dopaminergic drug to enhance UDP prestudy 1 motor training only and the effects of a dopaminergic drug on RAC-BP during resting condition prestudy 2 RAC-PET during resting condition only
UDP will be assessed using a technique developed in our lab in which we have extensive experience In short we will evaluate TMS-evoked thumb movement directions after a period of motor training consisting of performance of voluntary thumb movements for 30 minutes Striatal and cortical dopamine release will be assessed with positron emission tomography using the dopamine-D2 receptor radioligand 11Craclopride after administration of placebo and after administration of a dopaminergic drug The study will be initially done in a group of healthy volunteers and then in a group of patients with chronic subcortical stroke who experienced good motor recovery
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 |
|---|---|---|---|
| 03-N-0266 | None | None | None |