Effect of tDCS on Postural Control of Children With DCD

Effect of Transcranial Direct Current Stimulation (tDCS) on Postural Control of Children With Developmental Coordination Disorder: a Double-blind Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Developmental Coordination Disorder
• Intervention / Treatment: Device: Transcranial direct current stimulation (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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01246-903
    • Department of Physical Therapy, Communication Sciences and Disorders, and Occupational Therapy, Faculty of Medicine, University of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Anodal tDCS (M1); tDCS applied over primary motor cortex. Dose: 1mA, 20 minutes	Device: Transcranial direct current stimulation (tDCS); Transcranial direct current stimulation is a noninvasive technique of neuronal modulation that has been used in different neurological conditions, including children with cerebral palsy.
Experimental: Anodal Cerebellar tDCS; tDCS applied over the cerebellum. Dose: 1mA, 20 minutes	Device: Transcranial direct current stimulation (tDCS); Transcranial direct current stimulation is a noninvasive technique of neuronal modulation that has been used in different neurological conditions, including children with cerebral palsy.
Experimental: Cathodal Cerebellar tDCS; tDCS applied over the cerebellum. Dose: 1mA, 20 minutes	Device: Transcranial direct current stimulation (tDCS); Transcranial direct current stimulation is a noninvasive technique of neuronal modulation that has been used in different neurological conditions, including children with cerebral palsy.
Sham Comparator: Sham tDCS; tDCS applied over the cerebellum Dose: 1mA, 20 minutes (30s ON)	Device: Transcranial direct current stimulation (tDCS); Transcranial direct current stimulation is a noninvasive technique of neuronal modulation that has been used in different neurological conditions, including children with cerebral palsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from COP - AP axis	Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) in antero-posterior (AP) axis in centimeters	Baseline and Post-tDCS (immediately after tDCS)
Change from COP - ML axis	Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) in Mediolateral (ML) axis in centimeters	Baseline and Post-tDCS (immediately after tDCS)
Change from COP - area	Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) area (cm²)	Baseline and Post-tDCS (immediately after tDCS)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects	Adverse effects will be evaluated using structured questionnaire. Active collection uses a questionnaire with records of the duration (minutes or hours) and intensity (Numerical Rating Scale 0-10) of adverse symptoms reported by the patient. Complaints: Headache Scalp pain Tingling Itching Redness Burning sensations Sleepiness Trouble concentrating Nausea Mood change	Immediately after tDCS

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Renata H Hasue, pHD, Faculty of Medicine, University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): April 27, 2022
• Study Completion (Estimated): December 20, 2023

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (Actual): March 27, 2019

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Child Development; Children; Transcranial Direct Current Stimulation; Postural balance; Developmental coordination disorder
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Motor Skills Disorders
• Other Study ID Numbers: 39398214.4.3001.5391

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No