search
Back to results

Does tDCS Improve Motor Learning in Children With DCD?

Primary Purpose

Developmental Coordination Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transcrainial Direct Current Stimulation (tDCS)
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Developmental Coordination Disorder focused on measuring Neurodevelopment, Pediatrics, Motor Learning, Brain Imaging, Neuroscience

Eligibility Criteria

10 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Child Development Center, Owerko Centre Alberta Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Anodal tDCS Intervention Group

Sham tDCS Intervention Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Purdue Pegborad Test (PPT)
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.

Secondary Outcome Measures

Jebsen-Taylor Test of Hand Function (JTT)
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.
Serial Reaction Time Task (SRTT)
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.

Full Information

First Posted
February 27, 2018
Last Updated
March 23, 2020
Sponsor
University of Calgary
search

1. Study Identification

Unique Protocol Identification Number
NCT03453983
Brief Title
Does tDCS Improve Motor Learning in Children With DCD?
Official Title
Transcranial Direct Current Stimulation (tDCS): A Therapeutic Intervention for Motor Impairments in Children With Developmental Coordination Disorder (DCD).
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Coordination Disorder
Keywords
Neurodevelopment, Pediatrics, Motor Learning, Brain Imaging, Neuroscience

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The currently proposed study is a randomized, sham controlled clinical trial that includes 30 adolescents diagnosed with DCD. Participants will be randomized to one of two tDCS treatment groups.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anodal tDCS Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham tDCS Intervention Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcrainial Direct Current Stimulation (tDCS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Purdue Pegborad Test (PPT)
Description
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.
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Jebsen-Taylor Test of Hand Function (JTT)
Description
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.
Time Frame
20 minutes
Title
Serial Reaction Time Task (SRTT)
Description
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.
Time Frame
20 minutes
Other Pre-specified Outcome Measures:
Title
KINARM
Description
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.
Time Frame
45 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah M Dewey, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child Development Center, Owerko Centre Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Currently, there is no pre-determined plan to share any collected data with other researchers.
Citations:
PubMed Identifier
23106530
Citation
Smits-Engelsman BC, Blank R, van der Kaay AC, Mosterd-van der Meijs R, Vlugt-van den Brand E, Polatajko HJ, Wilson PH. Efficacy of interventions to improve motor performance in children with developmental coordination disorder: a combined systematic review and meta-analysis. Dev Med Child Neurol. 2013 Mar;55(3):229-37. doi: 10.1111/dmcn.12008. Epub 2012 Oct 29.
Results Reference
background
PubMed Identifier
19164589
Citation
Reis J, Schambra HM, Cohen LG, Buch ER, Fritsch B, Zarahn E, Celnik PA, Krakauer JW. Noninvasive cortical stimulation enhances motor skill acquisition over multiple days through an effect on consolidation. Proc Natl Acad Sci U S A. 2009 Feb 3;106(5):1590-5. doi: 10.1073/pnas.0805413106. Epub 2009 Jan 21.
Results Reference
background
PubMed Identifier
24367333
Citation
Goodwill AM, Reynolds J, Daly RM, Kidgell DJ. Formation of cortical plasticity in older adults following tDCS and motor training. Front Aging Neurosci. 2013 Dec 6;5:87. doi: 10.3389/fnagi.2013.00087. eCollection 2013.
Results Reference
background
PubMed Identifier
27166171
Citation
Ciechanski P, Kirton A. Transcranial Direct-Current Stimulation Can Enhance Motor Learning in Children. Cereb Cortex. 2017 May 1;27(5):2758-2767. doi: 10.1093/cercor/bhw114.
Results Reference
background
PubMed Identifier
27927938
Citation
Kirton A, Ciechanski P, Zewdie E, Andersen J, Nettel-Aguirre A, Carlson H, Carsolio L, Herrero M, Quigley J, Mineyko A, Hodge J, Hill M. Transcranial direct current stimulation for children with perinatal stroke and hemiparesis. Neurology. 2017 Jan 17;88(3):259-267. doi: 10.1212/WNL.0000000000003518. Epub 2016 Dec 7.
Results Reference
background
PubMed Identifier
27029628
Citation
Kirton A, Andersen J, Herrero M, Nettel-Aguirre A, Carsolio L, Damji O, Keess J, Mineyko A, Hodge J, Hill MD. Brain stimulation and constraint for perinatal stroke hemiparesis: The PLASTIC CHAMPS Trial. Neurology. 2016 May 3;86(18):1659-67. doi: 10.1212/WNL.0000000000002646. Epub 2016 Mar 30.
Results Reference
background
PubMed Identifier
28632467
Citation
Moura RCF, Santos C, Collange Grecco L, Albertini G, Cimolin V, Galli M, Oliveira C. Effects of a single session of transcranial direct current stimulation on upper limb movements in children with cerebral palsy: A randomized, sham-controlled study. Dev Neurorehabil. 2017 Aug;20(6):368-375. doi: 10.1080/17518423.2017.1282050. Epub 2017 Feb 25.
Results Reference
background
PubMed Identifier
27372845
Citation
Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.
Results Reference
background
PubMed Identifier
22405745
Citation
Ambrus GG, Al-Moyed H, Chaieb L, Sarp L, Antal A, Paulus W. The fade-in--short stimulation--fade out approach to sham tDCS--reliable at 1 mA for naive and experienced subjects, but not investigators. Brain Stimul. 2012 Oct;5(4):499-504. doi: 10.1016/j.brs.2011.12.001. Epub 2012 Feb 22.
Results Reference
background
PubMed Identifier
33362497
Citation
Grohs MN, Craig BT, Kirton A, Dewey D. Effects of Transcranial Direct Current Stimulation on Motor Function in Children 8-12 Years With Developmental Coordination Disorder: A Randomized Controlled Trial. Front Hum Neurosci. 2020 Dec 11;14:608131. doi: 10.3389/fnhum.2020.608131. eCollection 2020.
Results Reference
derived

Learn more about this trial

Does tDCS Improve Motor Learning in Children With DCD?

We'll reach out to this number within 24 hrs