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Trial record 9 of 39 for:    "Brain Injury" | "Dopamine"

Dopamine and Motor Learning in Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT02839733
Recruitment Status : Recruiting
First Posted : July 21, 2016
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

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


Condition or disease
Cerebral Palsy

Detailed Description:

Objective

The broad objective of this study is to determine the relationship between variations in genes related to dopamine (DA) neurotransmission in areas of the brain associated with motor leaning (e.g. DRD1, DRD2, DRD3, COMT, DAT) and/or to activity-dependent brain plasticity (e.g. BDNF) and differences in motor learning rates and cognitive processing abilities in persons with and without cerebral palsy (CP). We hypothesize that individual genetic differences will be related to the ability to learn new motor and cognitive skills and may thus provide a potential explanation for the often reported response variability to rehabilitative therapies seen in CP. We will also explore whether motor and cognitive learning abilities are correlated within individuals which could suggest similar underlying neural mechanisms. Finally we would like to evaluate the effect of rewards on procedural learning in CP, to preliminarily assess how behavioral manipulations of the DA system may affect learning across individuals.

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

Design: This protocol will consist of two separate but related studies: Study #1 is an observational trial whereby subjects with and without CP will participate in two different training paradigms, 10 sessions each, one that involves learning novel working memory tasks and one that involves motor skill learning in the lower extremities, adapted from the horizontal ladder task utilized in rodent studies. All will have blood draws for genetic analyses at baseline, the results of which will be related to changes in performance (learning) per task after training.

Study #2 will be a within-subjects evaluation in CP only on the effects of reward (versus no-reward) during learning, which is presumed to increase dopamine transmission. Mean and individual responses to reward-based learning will be assessed and related to genetic variations in dopamine transmission.

For subjects with CP, we would like to obtain brain MRI but this is optional and if they are unable or unwilling to do this portion, they can still participate in this protocol.

Outcome Measures: Primary outcomes are changes in performance (learning) on each task after training which will be related to presence or absence of polymorphisms that have been associated with brain plasticity or with deficits in working memory and/or motor learning. Individual responses to rewards will also be related to variations related to high versus low dopamine transmission in the brain.


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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Dopamine and Motor Learning in Cerebral Palsy
Actual Study Start Date : June 21, 2017
Estimated Primary Completion Date : May 22, 2025
Estimated Study Completion Date : May 22, 2025

Resource links provided by the National Library of Medicine


Group/Cohort
Cerebral Palsy
Children and young adults with Cerebral Palsy.
Healthy Volunteers
Children and young adults healthy volunteer



Primary Outcome Measures :
  1. Learning (specific measures vary by task) [ Time Frame: measure of learning of each training task across the entire training period ]
    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

  2. Genetic testing (for dopamine and activity-related genes) [ Time Frame: genetic analyses of individual variations ]
    COMT, BDNF, DAT, and DRD1, DRD2, DRD3



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
A maximum of 120 ambulatory children and young adults including pregnant women with and without CP (ages 5-25 inclusive) will be enrolled in this protocol.@@@
Criteria
  • 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:

  1. Pregnancy
  2. A ventriculo-peritoneal shunt
  3. Have claustrophobia and not comfortable in small enclosed spaces
  4. 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).
  5. Excessive startle reaction to or fear of loud noises

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02839733


Contacts
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Contact: Sara F Sadeghi (301) 451-7529 sara.sadeghi@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
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Principal Investigator: Diane L Damiano, Ph.D. National Institutes of Health Clinical Center (CC)

Additional Information:
Publications:
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Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT02839733     History of Changes
Other Study ID Numbers: 160149
16-CC-0149
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 24, 2019
Keywords provided by National Institutes of Health Clinical Center (CC):
Brain Imaging
Adult
DNA Testing
Children
Additional relevant MeSH terms:
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Brain Damage, Chronic
Dopamine
Dopamine Agents
Cerebral Palsy
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents