Does tDCS Improve Motor Learning in Children With DCD?

March 23, 2020 updated by: University of Calgary

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Methods:

A randomized, sham controlled clinical trial including a final sample of 30 school aged children diagnosed with DCD will be conducted. The current study will be using a well-supported stimulation protocol, utilized in children and adolescents in the absence of adverse side effects.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • Child Development Center, Owerko Centre Alberta Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anodal tDCS Intervention Group
Transcrainial Direct Current Stimulation (tDCS): The right primary motor cortex will be localized and a saline soaked sponge electrode will be placed onto M1 with a second saline soaked sponge electrode placed on the contralateral supraorbital region.
Device: Transcrainial Direct Current Stimulation (tDCS)
Transcranial direct current stimulation (tDCS) is a safe non-invasive form of brain stimulation, which modulates, through the application of weak direct current, cortical excitability. The applied subthreshold current passes through two externally placed electrodes, an anode and cathode.
Sham Comparator: Sham tDCS Intervention Group
Transcrainial Direct Current Stimulation (tDCS): The right primary motor cortex will be localized and a saline soaked sponge electrode will be placed onto M1 with a second saline soaked sponge electrode placed on the contralateral supraorbital region.
Device: Transcrainial Direct Current Stimulation (tDCS)
Transcranial direct current stimulation (tDCS) is a safe non-invasive form of brain stimulation, which modulates, through the application of weak direct current, cortical excitability. The applied subthreshold current passes through two externally placed electrodes, an anode and cathode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Purdue Pegborad Test (PPT)
Time Frame: 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.
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Jebsen-Taylor Test of Hand Function (JTT)
Time Frame: 20 minutes
The JTT is an upper extremity motor assessment aimed at testing practical everyday living skills, such as writing, picking up coins, and moving objects. Left and right hands are tested independently, and scores for each hand are obtained through recording task completion time.
20 minutes
Serial Reaction Time Task (SRTT)
Time Frame: 20 minutes
The SRTT is a measure of motor learning skills. Participants are cued on a computer monitor to press the indicated letter on the keyboard. Participants complete this task over eight blocks of trials, each consisting of 96 cued key commands.
20 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
KINARM
Time Frame: 45 minutes
Sensorimotor changes will be measured between baseline, post-training, and 6 week follow-up using the Kinesiological Instrument for Normal and Altered Reaching Movements (KINARM, BKIN Technologies Ltd, Ontario, Canada). The KINARM robot is a valid and reliable tool that can be used to measure children's proprioceptive, sensorimotor, visuomotor and motor decision/control abilities.
45 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Deborah M Dewey, PhD, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

February 27, 2018

First Submitted That Met QC Criteria

February 27, 2018

First Posted (Actual)

March 5, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB18-0183

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Currently, there is no pre-determined plan to share any collected data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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