Developmental Coordination Disorder Clinical Trial
Official title:
tDCS and Motor Learning in Children With DCD
Children with a neurodevelopmental condition called developmental coordination disorder (DCD) struggle to learn motor skills and perform daily activities, such as tying shoelaces, printing, riding a bicycle, or playing sports. Evidence suggests that motor-based interventions combined with non-invasive brain stimulation to the motor cortex (transcranial direct-current stimulation, tDCS) has been effective in improving motor skills in children with cerebral palsy and other neurodevelopmental disorders, but few studies have examined tDCS in chidlren with DCD. The purpose of this randomized, blinded, sham-controlled interventional trial is to explore the effectiveness of anodal tDCS over M1 combined with a motor learning task in increasing motor skill learning in children with DCD.
Transcranial direct-current stimulation (tDCS) is one of the most common non-invasive brain
stimulation techniques but applications in pediatric populations are relatively unexplored.
tDCS applies a weak electric current over the scalp to modulate cortical excitability. Anodal
stimulation excites the stimulated brain region. Anodal tDCS applied to the motor cortex
contralateral to the trained hand enhances motor learning across single or multiple day
training sessions (Reis 2009). tDCS has shown promising effects in the developing brain
including the potential to enhance motor skills that may then be transferred to other
untrained skills in typically developing children (Ciechanski 2017). tDCS is safe and
tolerable and a feasible technique with only mild short-term adverse effects (e.g., redness,
tingling, itching, and burning sensation) in children. The adverse effects usually occur at
electrode sites and disappear within a few minutes after stimulation starts (Krishnan 2015).
Combined with motor-based interventions, tDCS can enhance motor performance in adults (Reis
2009, 2011) and children (Gillick 2014; Grecco 2017; Kirton 2017; Moura 2016). It is
currently being used in combination with other treatments (e.g., behavioural therapy and
neurorehabilitation) in children and adolescents with neurodevelopmental disorders (Muszkat
2016), including Autism Spectrum Disorder (Amatachaya 2014) and
Attention-Deficit/Hyperactivity Disorder (ADHD) (Bandeira 2016), as well as motor disorders
such as Cerebral Palsy (Gillick 2014; Grecco 2017; Kirton 2017; Moura 2016). However, the
effect of tDCS on skill motor learning in children with Developmental Coordination Disorder
(DCD) is largely unexplored.
DCD is a chronic motor disorder of unknown etiology that affects 5-6% of school-aged children
in Canada (APA, 2013). DCD interferes with children's academic achievement and limits their
ability to participate in daily activities (e.g., printing, getting dressed, tying their
shoes, riding a bike, using cutlery), as well as vocational activities, leisure, and play
(APA, 2013).15 Subsequently, children may develop psychosocial difficulties, including low
self-esteem, depression, anxiety, loneliness, problems with peers, and poor participation in
physical and social activities (Zwicker 2013). DCD is a lifelong condition, and 75% of
children with DCD will continue to experience motor difficulties as adults if they don't
receive proper treatment (Kirby 2014). Up to half of children with DCD also have co-occurring
ADHD (Piek 1999).
Several brain regions have been implicated in DCD, including the cerebellum, basal ganglia,
parietal lobe, and parts of the frontal lobe (e.g., dorsolateral prefrontal cortex or DLPFC)
(Biotteau 2016). The primary motor cortex (M1) is located in the dorsal part of the frontal
lobe and is functionally connected to other motor areas. However, the functional connectivity
between M1 and brain regions involved in motor functioning and sensorimotor processing, such
as striatum and angular gyrus, may be decreased in children with DCD (McLeod 2014). Targeting
such specific brain regions in rehabilitation might be effective in improving the motor
outcomes of affected children.
Currently, the most beneficial interventions to improve the motor performance of children
with DCD are task-oriented approaches that focus on learning a particular task rather than on
the body functions required to perform a task (Smits-Engelsman 2013). A number of
task-oriented approaches are commonly used to treat children with DCD (Niemeijer 2007;
Polatajko 2001). The investigators believe that brain stimulation can enhance motor learning
and the effect of task-oriented approaches in children with DCD. To better understand tDCS as
a treatment for children with DCD, as the first step, it is critical to investigate whether
tDCS can enhance motor skill learning in this population. Therefore, the investigators aim to
conduct a randomized, blinded, sham-controlled interventional trial of anodal tDCS over M1
combined with a motor learning task to assess its effectiveness on motor skill learning in
children with DCD. This is a pilot study to determine a sample size for a larger study.
AIMS AND HYPOTHESES
Aim 1: To determine if transcranial direct current stimulation (tDCS) enhances motor learning
in children with DCD.
Hypothesis 1: Compared to children in sham group, children in stimulation group will show
better functional outcomes faster motor learning in each session (online learning) and after
3 sessions.
Aim 2: To determine the longevity of tDCS effects on motor learning in children with DCD.
Hypothesis 2: Children in stimulation group will maintain their motor learning after 6 weeks
compared to the sham group.
METHODOLOGY
Study Design: This study is a randomized, sham-controlled, double-blinded trial. Participants
will be randomly assigned to active or sham stimulation.
Participants: Children will be recruited from established cohorts of children with DCD who
were assessed at BC Children's Hospital or Sunny Hill Health Centre for Children (Vancouver,
BC) and who meet DSM-5 diagnostic criteria (American Psychiatric Association, 2013).
Sample size: Sample size was calculated based on a randomized sham-control designed study in
typically-developing children receiving M1 A-tDCS or sham tDCS over 3 consecutive days of
Purdue Pegboard Test training.4 Sample size calculation suggested a total of 14 subjects, 7
subjects per group, would have a power of 95% to detect improvement in Purdue Pegboard Test
(effect size = 2.58) with a type-1 error of 0.05.
Procedure: After screening and recruitment, parents will consent and children will assent to
take part in the study. We will randomize children to active or sham stimulation groups; a
statistician will randomize participants using computer-generated sequential blocks of 4 to
6. Randomization codes will be kept in sealed opaque envelopes until study enrollment. A
research graduate student with training in occupational therapy will be blinded to group
assignments and will assess children using Purdue Pegboard Test (PPT; Tiffin 1968),
Bruininks-Oseretsky Test of Motor Proficiency-2 (BOT-2; Bruininks 2005), and Evaluation Tool
of Children's Handwriting (ETCH; Amundson, 1995). Then, children will receive 3 days of tDCS
for 30 minutes each day; during the first 10 minutes, children will complete Purdue Pegboard
Test Training (to assess learning of a motor task), followed by 20 minutes of handwriting
practice using "Printing Like a Pro!"(Montgomery 2017), to assess learning of a functional
motor task). An occupational therapist will re-assess the children at the end of the last day
of training and again 6 weeks later.
Interventions
tDCS: Direct current will be delivered using a transcranial electrical stimulator approved by
Health Canada (Soterix Medical Inc., New York, USA) (Soterix Medical, 2016). Stimulation will
be applied to the scalp through two 5×7 cm sponge saline-soaked electrodes: active and
reference. A simple headgear system, including the EASYpads and EASYstraps, will hold the
electrodes in place. In the active stimulation and sham groups, the anode (active electrode)
will be positioned over the left primary motor cortex with the cathode (reference electrode)
over right forehead in supraorbital area. The international 10/20 electroencephalography
electrode system will be used to localize the M1 (Klem 1999). The dominant left motor cortex
will be stimulated because the investigators aim to simultaneously train the dominant hand
for a motor learning task and a functional task. The stimulation will be applied at 1 mA for
30 min. One mA of anodal stimulation may cause brain current densities in children on average
comparable to densities seen in adults exposed to 2 mA current (Kessler 2013) and the
subsequent excitability might last longer than one hour (Moliadze 2015). For active
stimulation groups, the current will be ramped up to 1 mA over 45-60 s, held for 30 min, and
ramped down to 0 mA over 45-60 s. For the sham groups, stimulation will be ramped up and held
for only 60 s before it is slowly ramped down. This procedure, called the Fade-in-Short
Stimulation-Fade out, has shown its reliability as an effective sham technique through making
the same tolerability and transient scalp sensation as active stimulation in both adults
(Ambrus 2012) and children (Ciechanski 2017). In case of any "Serious Adverse Events" (e.g.,
second-degree scalp burn at the site of electrode pad, or clinical seizure) occurring during
the course of study, it will be stopped immediately.
Motor Learning Task: Over three consecutive days, each child will perform five blocks of
Purdue Pegboard Test: one block before, three blocks during, and one block after tDCS. Each
block consists of three repetitions of Purdue Pegboard Test with the right hand. The children
have to place pins into a pegboard as fast as they can in 30 seconds. It will take up to 10
minutes of brain stimulation time.
Functional Motor Task: After the Purdue Pegboard Test, each child will receive
cognitive-based intervention for printing skills for 20 minutes while receiving tDCS.
"Printing Like a Pro!" (Montgomery 2017) —a cognitive approach to teaching printing to
primary school-age children—will be used to teach letters which each child has the most
difficulty printing legibly as identified on a formal assessment of handwriting—ETCH
(manuscript) (Amundson 1995).
Data Analysis Plan:
Purdue Pegboard Test is the primary outcome measure of interest. To measure online learning
within one session and off-line learning across sessions, we will apply Repeated Measure
Analysis of Co-variance (ANCOVA), with an α level of 0.05. To measure effect of intervention
and retention, we will apply a paired t-test and Repeated Measure ANCOVA to the primary and
secondary outcomes. Two-way ANCOVA and independent t-test will also be used to compare groups
(stimulation versus sham). MABC-2 scores and attention level as assessed by Conner's ADHD
Index will be used as covariates to account for individual differences in attention and motor
skills.
Significance:
This is the first study of its kind to both investigate the effect of brain stimulation in
motor learning in children with DCD and integrate technology to improve functional motor
learning for children with DCD. This study will contribute to planning more effective
interventions for these children to improve both their motor skills and functional outcomes.
Additionally, findings will be of interest to pediatric clinicians (e.g., occupational
therapists) and parents seeking more efficient approaches for these children, as well as
researchers, students, and policy makers in the field of neurorehabilitation.
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