Clinical trial NCT03453983: 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
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Coordination Disorder
Keywords: Neurodevelopment
Pediatrics
Motor Learning
Brain Imaging
Neuroscience
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 35
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Purdue Pegborad Test (PPT)
timeFrame: 20 minutes
Secondary outcomes:
measure: Jebsen-Taylor Test of Hand Function (JTT)
timeFrame: 20 minutes
measure: Serial Reaction Time Task (SRTT)
timeFrame: 20 minutes
Other outcomes:
measure: KINARM
timeFrame: 45 minutes
Locations:
city: Calgary
country: Canada
facility: Child Development Center, Owerko Centre Alberta Children's Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Deborah M Dewey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.