The Effect of Dopamine on Motor Skills Training
|First Received Date ICMJE||August 13, 2003|
|Last Updated Date||March 5, 2008|
|Start Date ICMJE||August 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00067275 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Effect of Dopamine on Motor Skills Training|
|Official Title ICMJE||Dopamine Release in Use-Dependent Plasticity in Health and Disease|
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)
Prestudy 2 (MRI, PET without motor training, no TMS)
Main Study (MRI, TMS, PET with motor training)
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 [(11)C]raclopride, 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 Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Cerebrovascular Accident|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Backman L, Ginovart N, Dixon RA, Wahlin TB, Wahlin A, Halldin C, Farde L. Age-related cognitive deficits mediated by changes in the striatal dopamine system. Am J Psychiatry. 2000 Apr;157(4):635-7.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||August 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Normal neurological and physical examination.
Abstinence from alcohol one week before the study.
No medication that can influence the central nervous system for at least one week before the study because those medications may influence DA release.
Within normal range of neuropsychological and mood assessment.
No gender or ethnic preferences.
Patients with thromboembolic or hemorrhagic lesions, without direct involvement of the dorsal striatum or the cerebellum, as documented by CT or MRI.
At least 6 months post-stroke.
Initially had a severe motor paresis (below MRC grade 2), which subsequently recovered to the point that they have a residual motor deficit but can perform the required task (thumb flexion and extension).
NORMAL VOLUNTEERS AND STROKE PATIENTS:
The subjects belonging to one of the following groups will be excluded from the study:
ADDITIONALLY FOR STROKE PATIENTS:
|Ages||18 Years to 80 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00067275|
|Other Study ID Numbers ICMJE||030266, 03-N-0266|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||August 2007|
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