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Protocol Details

Dopamine and Motor Learning in Cerebral Palsy

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

16-CC-0149

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 5 Years
Max Age: 25 Years

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Brain Imaging;
Adult;
DNA Testing;
Children;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Cerebral Palsy

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

NIH Clinical Center

Background:

Cerebral palsy (CP) is the most common childhood motor disability. The neurotransmitter dopamine (DA) is important in cognition and emotions/behavior. DA may also be important in motor skill learning. Genes that relate to DA function may affect a person s ability to learn new cognitive or motor skills. Some children with CP can learn motor skills easily while others have trouble. Researchers want to find out if DA gene variations cause some of this variability.

Objectives:

To learn more about how DA and its related genes affect motor and cognitive learning in people with and without CP.

Eligibility:

People ages 5 25 with and without CP who can:

Follow the protocol

Attend and perform the training sessions

Design:

Participants will be screened with:

Medical history

Physical exam

Blood draw for genetic tests

The study has 2 parts. Participants with CP can join both. Those without can join only Part 1.

All participants will have a baseline assessment: short motor skills test and blood draw.

Part 1:

Two 10-session training programs over 2 weeks. Cognitive training will be 2 sessions at the clinic, 8 at home. Participants will perform memory tasks on a computer. All 10 motor training sessions are at the clinic. Participants will step on lines in a virtual reality environment.

Part 2:

Two lab training sessions at least 1 week apart. Participants will perform tasks on a

computer.

Participants with CP may have a brain MRI at 1 visit. They will lie on a table that slides into a machine that takes pictures. They will be in the scanner about 45 minutes. They may have a

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Eligibility

INCLUSION CRITERIA:

For all subjects:

1. Ages 5-25 inclusive

2. Able to follow the study protocol

3. Able to attend or perform the training sessions as scheduled

Additional criteria for subjects with CP:

1. Diagnosis of cerebral palsy

2. Gross Motor Functional Classification Scale Level I-II (able to walk at least 10 meters without an assistive device)

EXCLUSION CRITERIA:

For all subjects:

1. Presence of an injury or other medical condition (besides CP) that would affect motor function or the ability to perform the motor training program.

Additional criteria for subjects with CP:

1. Less than 6 months after major surgery to their legs

2. Currently taking levodopa, trihexyphenidyl, methylphenidate or baclofen since these may affect dopamine transmission or neuroplasticity.

Additional criteria for those with CP who choose to have an MRI:

1. Have any of the following contraindications to having an MRI scan:

a. Pregnancy

b. A ventriculo-peritoneal shunt

c. Have claustrophobia and not comfortable in small enclosed spaces

d. Have metal that would make an MRI scan unsafe such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion devise, cochlear or ear implant, transdermal medication patch (nitroglycerine), any metallic implants or objects, body piercing that cannot be removed, bone or joint pin, screw, nail, plate, wire sutures or surgical staples, shunts, cerebral aneurysms clips, shrapnel or other metal embedded (such as from war wounds or accidents or previous work in metal fields or machines that may have left any metallic fragments in or near your eyes).

e. Excessive startle reaction to or fear of loud noises


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Citations:

Qian Y, Chen M, Forssberg H, Diaz Heijtz R. Genetic variation in dopamine-related gene expression influences motor skill learning in mice. Genes Brain Behav. 2013 Aug;12(6):604-14. doi: 10.1111/gbb.12062. Epub 2013 Jul 17.

Pearson-Fuhrhop KM, Minton B, Acevedo D, Shahbaba B, Cramer SC. Genetic variation in the human brain dopamine system influences motor learning and its modulation by L-Dopa. PLoS One. 2013 Apr 17;8(4):e61197. doi: 10.1371/journal.pone.0061197. Print 2013.

Molina-Luna K, Pekanovic A, R(SqrRoot)(Delta)hrich S, Hertler B, Schubring-Giese M, Rioult-Pedotti MS, Luft AR. Dopamine in motor cortex is necessary for skill learning and synaptic plasticity. PLoS One. 2009 Sep 17;4(9):e7082. doi: 10.1371/journal.pone.0007082.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Diane L. Damiano, Ph.D.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 1-1469
10 Center Drive
Bethesda, Maryland 20892
(301) 451-7544
damianod@cc.nih.gov

Mayra J. Medrano
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 1-1469
10 Center Drive
Bethesda, Maryland 20892
(301) 451-7529
mayra.medrano@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: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT02839733

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