Developmental Coordination DisorderNCT03892083
Effect of tDCS on Postural Control of Children With DCD
A study testing Transcranial direct current stimulation (tDCS) in people with Developmental Coordination Disorder, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Coordination Disorder
- What is being tested?
- Transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2019to 20 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- Signs of excessive discomfort during or after any procedures or sessions involved in the research.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Physical Therapy, Communication Sciences and Disorders, and Occupational Therapy, Faculty of Medicine, University of São Paulo
São Paulo, 01246-903
About this study
Official title: 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.
Read the 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.
- Conditions
- Developmental Coordination Disorder
- Being tested
- Transcranial direct current stimulation (tDCS)
- Keywords
- Developmental coordination disorder, Postural balance, Transcranial Direct Current Stimulation, Children, Child Development
- Medical subject headings
- Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS (M1) | Active comparator | tDCS applied over primary motor cortex. Dose: 1mA, 20 minutes Receives: Device: Transcranial direct current stimulation (tDCS) |
| Anodal Cerebellar tDCS | Experimental | tDCS applied over the cerebellum. Dose: 1mA, 20 minutes Receives: Device: Transcranial direct current stimulation (tDCS) |
| Cathodal Cerebellar tDCS | Experimental | tDCS applied over the cerebellum. Dose: 1mA, 20 minutes Receives: Device: Transcranial direct current stimulation (tDCS) |
| Sham tDCS | Sham comparator | tDCS applied over the cerebellum Dose: 1mA, 20 minutes (30s ON) Receives: Device: Transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: Baseline and Post-tDCS (immediately after tDCS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Feb 2019
- Primary completion27 Apr 2022
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Coordination DisorderStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renata H Hasue, pHD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892083
- Sponsor's protocol ID
- 39398214.4.3001.5391
- Status last verified
- Mar 2023
- First submitted
- 25 Mar 2019
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Direct Current Stimulation (tDCS) on Postural Control of Children With Developmental Coordination Disorder: a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03892083
- Acronym / sponsor ID
- 39398214.4.3001.5391
- Conditions
- Developmental Coordination Disorder
- Keywords
- Developmental coordination disorder, Postural balance, Transcranial Direct Current Stimulation, Children, Child Development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS (M1) | Active comparator | Device: Transcranial direct current stimulation (tDCS)tDCS applied over primary motor cortex. Dose: 1mA, 20 minutes |
| Anodal Cerebellar tDCS | Experimental | Device: Transcranial direct current stimulation (tDCS)tDCS applied over the cerebellum. Dose: 1mA, 20 minutes |
| Cathodal Cerebellar tDCS | Experimental | Device: Transcranial direct current stimulation (tDCS)tDCS applied over the cerebellum. Dose: 1mA, 20 minutes |
| Sham tDCS | Sham comparator | Device: Transcranial direct current stimulation (tDCS)tDCS applied over the cerebellum Dose: 1mA, 20 minutes (30s ON) |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Signs of excessive discomfort during or after any procedures or sessions involved in the research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Anodal Cerebellar tDCS, Anodal tDCS (M1), Cathodal Cerebellar tDCS, Sham tDCS |
Primary outcome
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
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
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renata H Hasue, pHD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (tDCS) in people with Developmental Coordination Disorder, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from COP - AP axis (time frame: Baseline and Post-tDCS (immediately after tDCS)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.