The Role of Dopamine in Motor Learning in Healthy Subjects and Patients With Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00032812
• Date of registration: 03/04/2002
• Prospective Registration: No
• Primary sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Public title: The Role of Dopamine in Motor Learning in Healthy Subjects and Patients With Parkinson's Disease
• Scientific title: Motor Memory: Study of the Role of Dopamine in Healthy Subjects and Patients With Parkinson's Disease Using PET and EEG
• Date of first enrolment: March 2002
• Target sample size: 64
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00032812
• Study type: Observational
• Study design: N/A
• Phase: N/A

Countries of recruitment

United States

Key inclusion & exclusion criteria

INCLUSION CRITERIA:

Patients must have a confirmed diagnosis of PD.

Patients will be asked to stop using antiparkinsonian medications for at least 12-18 hours
prior to examination (4 days for cabergoline).

Patients will also be asked to stop other medications that can influence the central
nervous system for one week prior to examination, also for the same time period they will
be asked to abstain from alcohol.

Patients with early PD (score on Hoehn & Yahr scale [257] less than 2).

The PD cohort will comprise only non-demented, non-depressed, right-handed patients with
right upper limb involvement and with parkinsonian symptoms and signs primarily
akineto-rigid.

If resting tremor is present, only patients with mild or moderate tremor (UPDRS [256]
tremor ratings 1 or 2 in the right upper limb) will be included in the study.

The criterion will be established by the preliminary screening in the NINDS Human Motor
Control Outpatient Clinic.

Subjects may be male or female.

EXCLUSION CRITERIA:

Subjects with a familial history of PD.

Patients with a marked resting tremor (score at the UPDRS scale above 2).

Patients with mild to moderate motor impairment (score at Hoehn & Yahr scale above 2).

Patients with progressive neurological disorders other than PD.

Subjects with cognitive impairment (score on BDI scale above 10).

Subjects with abnormal MRI findings at visual inspection (prominent normal variants such
as mega cisterna or cavum septum pellucidum, signs of severe cortical or subcortical
atrophy, brain tumors, vascular diseases, trauma or AVMs).

Subjects with a history of significant medical disorders, or requiring chronic treatment
with other drugs that cannot be stopped.

Subjects with prior exposure to neuroleptic agents or drug use.

Subjects with past and present history of hypertension, cardiovascular disease and
diabetes mellitus.

Subjects with severe orthopedic or rheumatologic pathology of the right upper limb.

Subjects with past or presents neuropsychatric illness, head trauma with loss of
consciousness, epilepsy, cerebro-vascular disease, past and present history of alcohol or
substance abuse, including cigarettes, medical conditions that may alter cerebral
functioning.

Subjects with cancer.

Subjects with positive urine toxicology.

Subjects who have pacemakers, aneurysm clips (metal clips on the wall of a large artery),
metallic prostheses (including heart valves and cochlear implants) or shrapnel fragments.

Subjects not capable of giving an informed consent.

Subjects with a positive pregnancy test.

Particpation of children:

Children will be excluded from the study for the following reasons:

PD is infrequent before the age of 30.

Absorbed radiation dose per mCI is relatively higher, and pharmacodynamic effects are
greater in children compared with adults.

No direct benefit for individual patients is anticipated from this study.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson Disease

Healthy

Intervention(s)

Drug: Raclopride

Secondary ID(s)

020153

02-N-0153

Source(s) of Monetary Support

Please refer to primary and secondary sponsors