跳至主要内容
临床试验/NCT03453983
NCT03453983已完成不适用

Transcranial Direct Current Stimulation (tDCS): A Therapeutic Intervention for Motor Impairments in Children With Developmental Coordination Disorder (DCD).

University of Calgary2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Purdue Pegborad Test (PPT)

研究概览

简要总结

Transcrainial direct current stimulation (tDCS) has become increasingly popular over the past decade. tDCS is a safe and well-studied form of non-invasive brain stimulation. The purpose of the current study is to see if tDCS can improve motor function in children with developmental coordination disorder.

Non-invasive brain stimulation is shown to positively affect motor performance in children with neurodevelopmental and/or neurological conditions. For example, tDCS improves hand motor function in children with paediatric stroke and cerebral palsy. The benefits of tDCS in developmental coordination disorder is unknown. The current study will assess children's motor performance before and after tDCS intervention.

详细描述

Developmental Coordination Disorder (DCD) is a chronic neurodevelopmental disorder characterized by impairments in coordinated motor abilities. Affected individuals show differences in brain maturation and early motor development, negatively impacting performance on everyday living tasks such as writing and participation in sports. Currently, there are few evidence-based therapeutic interventions for individuals diagnosed with DCD, and most are time consuming with modest effect sizes [1]. There is a pressing need to develop efficient, effective interventions to improve motor performance in children with DCD, as impairments often last into adulthood and can negatively impact long-term physical and mental health as well as social and academic abilities.

The ability to enhance endogenous motor learning systems with non-invasive brain stimulation is now well established in adults [2, 3]. Research studies have demonstrated the same potential in the developing brain. For instance, tDCS can significantly enhance the acquisition of motor skills over a few brief training sessions in typically developing school aged children, with lasting effects [4]. Recent clinical trials in children with cerebral palsy and neonatal stroke also suggest therapeutic efficacy in children with motor impairment [5, 6, 7]. However, the use of tDCS in pediatric populations is limited [8]. As tDCS has been associated with improved motor outcomes in adults and children with motor impairment, it may be an effective intervention for children with DCD. This however has not been investigated.

Research Questions & Objectives:

The current study will investigate the therapeutic benefits of tDCS in adolescents with DCD. The primary aim is to determine changes in motor skill acquisition and learning during a skill-training paradigm that is paired with anodal tDCS or sham tDCS. We hypothesize that when compared to the sham tDCS group, the treatment tDCS group will show enhanced motor learning on tests of motor functioning.

Secondarily we will also examine sensorimotor changes following tDCS intervention and pediatric brain stimulation safety/tolerability.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants will not be informed of the stimulation group to which they are randomized. Both stimulation groups produce similar transient scalp sensations in participants and the sham protocol that will be used has been shown to be valid and ensures that participants are naïve to their assigned treatment group [9]. Participants will be asked which stimulation group they felt they took part in to ensure adequate blinding.

Outcomes assessors will be blinded. Offline video analysis will be used to score motor assessment performance. These videos will exclude all identifying information including the participant's face and their stimulation group.

入排标准

年龄范围
10 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosed and documented DCD (including individuals with additional diagnoses of attention and/or learning disorders)
  • Aged 10 to 15 years
  • Right Handed

排除标准

  • Presence of implanted electrical devices, metallic implants, and/or irremovable metal objects (i.e., cardiac pacemakers, braces etc.)
  • Pregnancy or possibility of pregnancy
  • Diagnosed with a neuropsychiatric disorder such as autism spectrum disorder or chronic medical condition such as cerebral palsy or epilepsy
  • Taking prescribed medications

结局指标

主要结局

Purdue Pegborad Test (PPT)

时间窗: 20 minutes

The PPT is a valid measure of fine motor coordination, hand dexterity, and motor learning skills, which consists of 4 subtests: left hand peg placement \[PPTL\], right hand peg placement \[PPTR\], bimanual peg placement \[PPTLR\], and bimanual assembly \[PPTA\]. The PPT peg placement subtests involve placing as many pins as possible into a pegboard during a 30 second interval. The total number of pegs, or pairs of pegs, placed are counted and scored. The PPT assembly subtest involved building as many copies of a demonstration structure using pins, pegs, and washers within a 60 second time period.

次要结局

  • Jebsen-Taylor Test of Hand Function (JTT)(20 minutes)
  • Serial Reaction Time Task (SRTT)(20 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验