Clinical trial NCT03892083: Effect of tDCS on Postural Control of Children With DCD
Official title: Effect of Transcranial Direct Current Stimulation (tDCS) on Postural Control of Children With Developmental Coordination Disorder: a Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Developmental Coordination Disorder
Keywords: Developmental coordination disorder
Postural balance
Transcranial Direct Current Stimulation
Children
Child Development
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the effects of Transcranial Direct Current Stimulation (tDCS) on postural control of children with Developmental Coordination Disorder (DCD). All participants will receive four conditions of stimulation, in a crossover protocol: cerebellar anodic, cerebellar cathodic, primary motor cortex anodic (M1) or sham tDCS.

Detailed description: Developmental Coordination Disorder (DCD) is a highly frequent neurodevelopmental disorder with negative impacts on children's motor repertoire, quality of life and general health. One of the main problems faced is the balance deficit, which although well characterized in this population, little is known about the etiological core of this impairment. The cerebellum appears to be a functionally impaired structure in DCD, but frontal motor areas are also involved. Transcranial Direct Current Stimulation (tDCS) is a noninvasive way of inducing local-specific polarity-dependent synaptic modulation. Cerebellar tDCS (CE-tDCS) is even more recent, with still unclear results on its effects on postural balance, with only one study in children, which requires us to better understand the type of stimulation necessary to induce balance improvement in children with DCD.

Thus, the investigators aimed to verify the effects of anodal tDCS over primary motor cortex (M1-atDCS) and CE-tDCS (anodic, cathodic and sham) on the balance of children with DCD, compared to children without DCD.

METHODS: Fifteen children with DCD (total MABC-2 and balance \<15%, with DCDQ positive / TL positive) and 15 children without DCD (MABC-2 total and balance ≥50% and DCDQ negative) will be assessed by platform stabilometry (PS) before and after receiving M1, cerebellar anodic, cerebellar cathodic, primary motor cortex anodic (M1) or sham tDCS (crossover). They will be evaluated under conditions without proprioceptive manipulation (direct on PS) with open and closed eyes, and with proprioceptive manipulation (on foam surface) with open and closed eyes.

Eligibility criteria: Inclusion Criteria:

* children of both sex, aged between seven years 0 months and 10 years and 11 months;
* Assent of the child by the Term of Assent and acceptance of parents and / or guardians to participate in the study by signing the Free and Informed Consent Form;
* Children with DCD indicative according to DSM-5 presenting Percentile \<15 in the MABC-2 Motor Evaluation Battery and in the balance domain; and the score indicated for each age by the Developmental Coordination Disorder Questionnaire DCDQ-Brazil (TDC Group).
* Children without DCD presenting Percentile ≥ 50 in the total score and in the MABC-2 Motor Assessment Battery Balance domain, without indicative by DCDQ (Control Group - GC).
* Absence of intellectual disability considering performance above the 25th percentile on the RAVEN Color Progressive Matrix scale
* Absence of visual or auditory deficiencies; cardiopathies; rheumatic or orthopedic dysfunctions; neurological or psychiatric problems (except ADHD and language disorder because they are the most comorbid disorders with DCD).

Exclusion Criteria:

• Signs of excessive discomfort during or after any procedures or sessions involved in the research.

Primary outcomes:
measure: Change from COP - AP axis
timeFrame: Baseline and Post-tDCS (immediately after tDCS)
measure: Change from COP - ML axis
timeFrame: Baseline and Post-tDCS (immediately after tDCS)
measure: Change from COP - area
timeFrame: Baseline and Post-tDCS (immediately after tDCS)
Secondary outcomes:
Other outcomes:
measure: Adverse effects
timeFrame: Immediately after tDCS
Locations:
city: São Paulo
country: Brazil
facility: Department of Physical Therapy, Communication Sciences and Disorders, and Occupational Therapy, Faculty of Medicine, University of São Paulo
Study officials:
affiliation: Faculty of Medicine, University of São Paulo
name: Renata H Hasue, pHD
role: PRINCIPAL_INVESTIGATOR
References: