Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of tDCS on Postural Control of Children With DCD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03892083
Recruitment Status : Unknown
Verified March 2019 by University of Sao Paulo General Hospital.
Recruitment status was:  Recruiting
First Posted : March 27, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Developmental Coordination Disorder Device: Transcranial direct current stimulation (tDCS) Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Transcranial Direct Current Stimulation (tDCS) on Postural Control of Children With Developmental Coordination Disorder: a Double-blind Randomized Controlled Trial
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : April 27, 2019
Estimated Study Completion Date : December 20, 2020
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change from COP - AP axis [ Time Frame: Baseline and Post-tDCS (immediately after tDCS) ]
    Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) in antero-posterior (AP) axis in centimeters

  2. Change from COP - ML axis [ Time Frame: Baseline and Post-tDCS (immediately after tDCS) ]
    Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) in Mediolateral (ML) axis in centimeters

  3. Change from COP - area [ Time Frame: Baseline and Post-tDCS (immediately after tDCS) ]
    Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) area (cm²)


Other Outcome Measures:
  1. Adverse effects [ Time Frame: Immediately after tDCS ]

    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



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03892083


Contacts
Layout table for location contacts
Contact: Renata H Hasue, pHD +5511983207232 renatahhv@usp.br
Contact: Maria Clara DS Moura, pHD studant +5511984554544 mclaramoura@usp.br

Locations
Layout table for location information
Brazil
Department of Physical Therapy, Communication Sciences and Disorders, and Occupational Therapy, Faculty of Medicine, University of São Paulo Recruiting
São Paulo, Brazil, 01246-903
Contact: Roseane O Nascimento, pHD    +5511981086483    ron18108@gmail.com   
Contact: Maria Clara DS Moura, pHD Studant    +5511984554544    mclaramoura@usp.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Renata H Hasue, pHD Faculty of Medicine, University of São Paulo
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03892083    
Other Study ID Numbers: 39398214.4.3001.5391
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Sao Paulo General Hospital:
Developmental coordination disorder
Postural balance
Transcranial Direct Current Stimulation
Children
Child Development
Additional relevant MeSH terms:
Layout table for MeSH terms
Motor Skills Disorders
Neurodevelopmental Disorders
Mental Disorders