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临床试验/NCT02839733
NCT02839733终止不适用

Dopamine and Motor Learning in Cerebral Palsy

National Institutes of Health Clinical Center (CC)1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2017年6月21日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
28
试验地点
1
主要终点
Learning (specific measures vary by task)

研究概览

简要总结

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

详细描述

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 those with and without CP, to preliminarily assess how behavioral manipulations of the DA system may affect learning.

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.

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 and controls 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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
5 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Learning (specific measures vary by task)

时间窗: 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

Genetic testing (for dopamine and activity-related genes)

时间窗: genetic analyses of individual variations

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

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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