NCT03892083

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2022

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

August 8, 2023

Status Verified

March 1, 2023

Enrollment Period

3.2 years

First QC Date

March 25, 2019

Last Update Submit

August 3, 2023

Conditions

Developmental Coordination Disorder

Keywords

Developmental coordination disorderPostural balanceTranscranial Direct Current StimulationChildrenChild Development

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Adverse effects

    Immediately after tDCS

Study Arms (4)

Anodal tDCS (M1)

ACTIVE COMPARATOR

tDCS applied over primary motor cortex. Dose: 1mA, 20 minutes

Device: Transcranial direct current stimulation (tDCS)

Anodal Cerebellar tDCS

EXPERIMENTAL

tDCS applied over the cerebellum. Dose: 1mA, 20 minutes

Device: Transcranial direct current stimulation (tDCS)

Cathodal Cerebellar tDCS

EXPERIMENTAL

tDCS applied over the cerebellum. Dose: 1mA, 20 minutes

Device: Transcranial direct current stimulation (tDCS)

Sham tDCS

SHAM COMPARATOR

tDCS applied over the cerebellum Dose: 1mA, 20 minutes (30s ON)

Device: Transcranial direct current stimulation (tDCS)

Interventions

Transcranial direct current stimulation (tDCS)DEVICE

Transcranial direct current stimulation is a noninvasive technique of neuronal modulation that has been used in different neurological conditions, including children with cerebral palsy.

Anodal Cerebellar tDCSAnodal tDCS (M1)Cathodal Cerebellar tDCSSham tDCS

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy, Communication Sciences and Disorders, and Occupational Therapy, Faculty of Medicine, University of São Paulo

São Paulo, 01246-903, Brazil

Location

MeSH Terms

Conditions

Motor Skills Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Renata H Hasue, pHD

    Faculty of Medicine, University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2019

First Posted

March 27, 2019

Study Start

February 1, 2019

Primary Completion

April 27, 2022

Study Completion

December 20, 2023

Last Updated

August 8, 2023

Record last verified: 2023-03

Locations

BR(1)