Dopamine and Motor Learning in Cerebral Palsy

NCT02839733 | Terminated

• 2 other identifiers: 16014916-CC-0149
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cerebral Palsy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Learning (specific measures vary by task)

  There will be two tasks : 1 a motor task which involves walking across a horizontal ladder. 2. Computer base tasks targeting working memory and procedural learning

  measure of learning of each training task across the entire training period

• Genetic testing (for dopamine and activity-related genes)

  COMT, BDNF, DAT, and DRD1, DRD2, DRD3

  genetic analyses of individual variations

Study Arms (2)

Cerebral Palsy

Children and young adults with Cerebral Palsy.

Healthy Volunteer

Children and young adults healthy volunteer

Eligibility Criteria

• Age: 5 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

A maximum of 120 ambulatory children and young adults with and without CP (ages 5-25 inclusive) will be enrolled in this protocol.

You may qualify if:

• For all subjects:
• Ages 5-25 inclusive
• Able to follow the study protocol
• Able to attend or perform the training sessions as scheduled
• Additional criteria for subjects with CP:
• Diagnosis of cerebral palsy
• Gross Motor Functional Classification Scale Level I-II (able to walk at least 10 meters without an assistive device)

You may not qualify if:

• For all subjects:
• \. 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:
• Less than 6 months after major surgery to their legs
• 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:
• \. Have any of the following contraindications to having an MRI scan:
• Pregnancy
• A ventriculo-peritoneal shunt
• Have claustrophobia and not comfortable in small enclosed spaces
• 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).
• Excessive startle reaction to or fear of loud noises

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 23819855 BACKGROUND

• 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.

  PMID: 23613810 BACKGROUND

• Molina-Luna K, Pekanovic A, Rohrich 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.

  PMID: 19759902 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Diane L Damiano, Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 21, 2016
• Study Start: June 21, 2017
• Primary Completion: December 10, 2021
• Study Completion: November 12, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)