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Protocol Details

Imaging Biomarkers in Parkinson Disease

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

12-N-0031

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Brain Imaging;
Parkinson's Disease;
Parkinsonism

Recruitment Keyword(s)

Parkinson Disease;
PD;
Healthy Volunteer;
HV

Condition(s)

Parkinson Disease

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

Background:

- Parkinson s disease (PD) causes slow movement, stiffness, and tremor. It results from the loss of a brain chemical called dopamine. PD gets worse over time, but researchers do not fully understand why the brain cells that produce dopamine stop working or die in people with PD. This study will use different ways of imaging the brain and brain chemicals to look at PD. It will compare brain imaging in people who definitely have PD to people who might have PD and to people without signs of PD. It will provide more information how the brain in people with PD changes over time.

Objectives:

- To understand the changes that occur in the brains of people with Parkinson s disease.

Eligibility:

- Individuals at least 18 years of age who have definite or possible Parkinson s disease.

- Healthy volunteers at least 18 years of age.

Design:

- Participants will have a screening visit with a physical exam and medical history. Blood and urine samples will be collected.

- Participants will visit the National Institutes of Health Clinical Center once a year for 9 years. There will be 10 total visits. Most visits will last 5 to 6 hours a day for 2 to 3 days. Some or all of the following tests will be performed at each visit:

- Transcranial sonography, which uses sound waves to take pictures of the brain.

- Magnetic resonance imaging to take pictures of the brain. Some of these tests will be done at rest. Others will require participants to perform an activity during the scan.

- Dopamine imaging studies to show how the brain uses the chemical dopamine.

- Magnetoencephaolgraphy to show brain activity.

- Electromyography to show muscle activity.

- Medication withdrawal for 12 hours overnight for people taking PD medications. This may be done before some scans. Participants who feel unwell when they stop taking medications will be allowed to start taking them again.

- Participants will continue with the followup visits until the end of the study.

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Eligibility

INCLUSION CRITERIA:

For all subjects:

1. Age 18 or older

2. Able to abstain from caffeine and alcohol for 48 hours before each of the DAT SPECT scans.

For PD cohort:

1. Must demonstrate at least 3 of the following features of PD: bradykinesia, resting tremor, cogwheel rigidity or postural reflex impairment.

2. At least one of the 3 clinical features must be resting tremor or bradykinesia.

3. Currently taking or history of taking dopaminergic therapy with symptomatic response.

4. Able to give informed consent or, if there is evidence of cognitive decline, able to appoint a durable power of attorney (DPA) who can give informed consent.

For EP cohort:

1. Have experienced at least one but fewer than three of the cardinal symptoms of PD (rest tremor, bradykinesia, rigidity) at the time of enrollment.

2. Able to give informed consent or, if there is evidence of cognitive decline, able to appoint a durable power of attorney (DPA) who can give informed consent

EXCLUSION CRITERIA:

Exclusion criteria for all subjects:

1. Use of illegal drugs within the past 6 months

2. More than 7 alcoholic drinks a week for females or 14 alcoholic drinks a week for males.

3. History of a neurologic disorder such as a brain tumor, stroke, central nervous system infection, multiple sclerosis, a movement disorder epilepsy or a history of seizures.

4. History of any head injury with loss of consciousness

5. Pregnancy or positive pregnancy test before the research procedure due to the risks associated with MRI and DAT SPECT scans. This would exclude subjects from participating in the protocol at that time.

6. Inability to lie flat on the back for up to 2 hours

7. Claustrophobia or a feeling of discomfort from being in small, enclosed spaces.

8. Surgically or traumatically implanted metallic foreign bodies, such as pacemakers, implanted medical pumps, implanted hearing aids, metal plates in the skull or metal implants in the skull or eyes (other than dental fillings) that may be physically hazardous during an MRI, or might distort the images.

9. Ablative surgery or implanted electrodes and generator for deep brain stimulation

10. Use of the following medications or substances within 6 months of getting DAT SPECT scan: Cocaine, amphetamines, methylphenidate, ephedrine, phentermine, buproprion, fentanyl, ketamine, phencyclidine.

11. Use of the following therapies which may affect mitochondrial function: Coenzyme Q10, vitamin E, vitamin C, anti-retroviral drugs, chemotherapeutic agents, anti-epileptics agents or antibiotics. (Use of these substances will prevent getting MRS scan only).

12. Have uncontrolled head movements that may impair image data collection (for PD and EP cohorts)

13. Have clinically relevant focal neurological findings on exam that suggest cerebral pathology other than that associated with parkinsonism (for PD and EP cohorts)

14. Any abnormal or focal finding on neurological exam (for healthy volunteer cohort only).


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Citations:

Narendra DP, Jin SM, Tanaka A, Suen DF, Gautier CA, Shen J, Cookson MR, Youle RJ. PINK1 is selectively stabilized on impaired mitochondria to activate Parkin. PLoS Biol. 2010 Jan 26;8(1):e1000298.

Olanow CW, Stern MB, Sethi K. The scientific and clinical basis for the treatment of Parkinson disease (2009). Neurology. 2009 May 26;72(21 Suppl 4):S1-136.

Schapira AH. Mitochondria in the aetiology and pathogenesis of Parkinson's disease. Lancet Neurol. 2008 Jan;7(1):97-109.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Silvina G. Horovitz, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 7D37
10 Center Drive
Bethesda, Maryland 20892
(301) 435-2163
silvina.horovitz@nih.gov

Elaine P. Considine, R.N.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 7D36
10 Center Drive
Bethesda, Maryland 20892
(301) 435-8518
considinee@ninds.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT01496599

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