Developmental Coordination DisorderNCT03453983
Does tDCS Improve Motor Learning in Children With DCD?
A study testing Transcrainial Direct Current Stimulation (tDCS) in people with Developmental Coordination Disorder, run by University of Calgary at 1 site in Canada.
Trial summary
Transcrainial direct current stimulation (tDCS) has become increasingly popular over the past decade. tDCS is a safe and well-studied form of non-invasive brain stimulation. The purpose of the current study is to see if tDCS can improve motor function in children with developmental coordination disorder. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Developmental Coordination Disorder
- What is being tested?
- Transcrainial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2018to 30 Nov 2019
- 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 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed and documented DCD (including individuals with additional diagnoses of attention and/or learning disorders)
- Aged 10 to 15 years
- Right Handed
Who cannot join
- Presence of implanted electrical devices, metallic implants, and/or irremovable metal objects (i.e., cardiac pacemakers, braces etc.)
- Pregnancy or possibility of pregnancy
- Diagnosed with a neuropsychiatric disorder such as autism spectrum disorder or chronic medical condition such as cerebral palsy or epilepsy
- Taking prescribed medications
Trial locations and contacts
1 site in 1 country.
Canada1 site
Child Development Center, Owerko Centre Alberta Children's Hospital
Calgary, Alberta, T2N 1N4
About this study
Official title: Transcranial Direct Current Stimulation (tDCS): A Therapeutic Intervention for Motor Impairments in Children With Developmental Coordination Disorder (DCD).
Transcrainial direct current stimulation (tDCS) has become increasingly popular over the past decade. tDCS is a safe and well-studied form of non-invasive brain stimulation. The purpose of the current study is to see if tDCS can improve motor function in children with developmental coordination disorder.
Non-invasive brain stimulation is shown to positively affect motor performance in children with neurodevelopmental and/or neurological conditions. For example, tDCS improves hand motor function in children with paediatric stroke and cerebral palsy. The benefits of tDCS in developmental coordination disorder is unknown. The current study will assess children's motor performance before and after tDCS intervention.
Read the detailed description
Developmental Coordination Disorder (DCD) is a chronic neurodevelopmental disorder characterized by impairments in coordinated motor abilities. Affected individuals show differences in brain maturation and early motor development, negatively impacting performance on everyday living tasks such as writing and participation in sports. Currently, there are few evidence-based therapeutic interventions for individuals diagnosed with DCD, and most are time consuming with modest effect sizes [1]. There is a pressing need to develop efficient, effective interventions to improve motor performance in children with DCD, as impairments often last into adulthood and can negatively impact long-term physical and mental health as well as social and academic abilities.
The ability to enhance endogenous motor learning systems with non-invasive brain stimulation is now well established in adults [2, 3]. Research studies have demonstrated the same potential in the developing brain. For instance, tDCS can significantly enhance the acquisition of motor skills over a few brief training sessions in typically developing school aged children, with lasting effects [4]. Recent clinical trials in children with cerebral palsy and neonatal stroke also suggest therapeutic efficacy in children with motor impairment [5, 6, 7]. However, the use of tDCS in pediatric populations is limited [8]. As tDCS has been associated with improved motor outcomes in adults and children with motor impairment, it may be an effective intervention for children with DCD. This however has not been investigated.
Research Questions \& Objectives:
The current study will investigate the therapeutic benefits of tDCS in adolescents with DCD. The primary aim is to determine changes in motor skill acquisition and learning during a skill-training paradigm that is paired with anodal tDCS or sham tDCS. We hypothesize that when compared to the sham tDCS group, the treatment tDCS group will show enhanced motor learning on tests of motor functioning.
Secondarily we will also examine sensorimotor changes following tDCS intervention and pediatric brain stimulation safety/tolerability.
Methods:
A randomized, sham controlled clinical trial including a final sample of 30 school aged children diagnosed with DCD will be conducted. The current study will be using a well-supported stimulation protocol, utilized in children and adolescents in the absence of adverse side effects.
- Conditions
- Developmental Coordination Disorder
- Being tested
- Transcrainial Direct Current Stimulation (tDCS)
- Keywords
- Neurodevelopment, Pediatrics, Motor Learning, Brain Imaging, Neuroscience
- 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.
Transcrainial Direct Current Stimulation (tDCS)Device
Transcranial direct current stimulation (tDCS) is a safe non-invasive form of brain stimulation, which modulates, through the application of weak direct current, cortical excitability. The applied subthreshold current passes through two externally placed electrodes, an anode and cathode.
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS Intervention Group | Experimental | Transcrainial Direct Current Stimulation (tDCS): The right primary motor cortex will be localized and a saline soaked sponge electrode will be placed onto M1 with a second saline soaked sponge electrode placed on the contralateral supraorbital region. Receives: Device: Transcrainial Direct Current Stimulation (tDCS) |
| Sham tDCS Intervention Group | Sham comparator | Transcrainial Direct Current Stimulation (tDCS): The right primary motor cortex will be localized and a saline soaked sponge electrode will be placed onto M1 with a second saline soaked sponge electrode placed on the contralateral supraorbital region. Receives: Device: Transcrainial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Purdue Pegborad Test (PPT)
The PPT is a valid measure of fine motor coordination, hand dexterity, and motor learning skills, which consists of 4 subtests: left hand peg placement [PPTL], right hand peg placement [PPTR], bimanual peg placement [PPTLR], and bimanual assembly [PPTA]. The PPT peg placement subtests involve placing as many pins as possible into a pegboard during a 30 second interval. The total number of pegs, or pairs of pegs, placed are counted and scored. The PPT assembly subtest involved building as many copies of a demonstration structure using pins, pegs, and washers within a 60 second time period.
Measured: 20 minutes
Secondary outcomes (2)
Jebsen-Taylor Test of Hand Function (JTT)
The JTT is an upper extremity motor assessment aimed at testing practical everyday living skills, such as writing, picking up coins, and moving objects. Left and right hands are tested independently, and scores for each hand are obtained through recording task completion time.
Measured: 20 minutes
Serial Reaction Time Task (SRTT)
The SRTT is a measure of motor learning skills. Participants are cued on a computer monitor to press the indicated letter on the keyboard. Participants complete this task over eight blocks of trials, each consisting of 96 cued key commands.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start1 Jun 2018
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Developmental Coordination DisorderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The currently proposed study is a randomized, sham controlled clinical trial that includes 30 adolescents diagnosed with DCD. Participants will be randomized to one of two tDCS treatment groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah M Dewey, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453983
- Sponsor's protocol ID
- REB18-0183
- Status last verified
- Apr 2019
- First submitted
- 27 Feb 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, there is no pre-determined plan to share any collected data with other researchers.
Publications
Smits-Engelsman BC, Blank R, van der Kaay AC, Mosterd-van der Meijs R, Vlugt-van den Brand E, Polatajko HJ, Wilson PH. Efficacy of interventions to improve motor performance in children with developmental coordination disorder: a combined systematic review and meta-analysis. Dev Med Child Neurol. 2013 Mar;55(3):229-37. doi: 10.1111/dmcn.12008. Epub 2012 Oct 29.
PubMed 23106530Reis J, Schambra HM, Cohen LG, Buch ER, Fritsch B, Zarahn E, Celnik PA, Krakauer JW. Noninvasive cortical stimulation enhances motor skill acquisition over multiple days through an effect on consolidation. Proc Natl Acad Sci U S A. 2009 Feb 3;106(5):1590-5. doi: 10.1073/pnas.0805413106. Epub 2009 Jan 21.
PubMed 19164589Goodwill AM, Reynolds J, Daly RM, Kidgell DJ. Formation of cortical plasticity in older adults following tDCS and motor training. Front Aging Neurosci. 2013 Dec 6;5:87. doi: 10.3389/fnagi.2013.00087. eCollection 2013.
PubMed 24367333Ciechanski P, Kirton A. Transcranial Direct-Current Stimulation Can Enhance Motor Learning in Children. Cereb Cortex. 2017 May 1;27(5):2758-2767. doi: 10.1093/cercor/bhw114.
PubMed 27166171Kirton A, Ciechanski P, Zewdie E, Andersen J, Nettel-Aguirre A, Carlson H, Carsolio L, Herrero M, Quigley J, Mineyko A, Hodge J, Hill M. Transcranial direct current stimulation for children with perinatal stroke and hemiparesis. Neurology. 2017 Jan 17;88(3):259-267. doi: 10.1212/WNL.0000000000003518. Epub 2016 Dec 7.
PubMed 27927938Kirton A, Andersen J, Herrero M, Nettel-Aguirre A, Carsolio L, Damji O, Keess J, Mineyko A, Hodge J, Hill MD. Brain stimulation and constraint for perinatal stroke hemiparesis: The PLASTIC CHAMPS Trial. Neurology. 2016 May 3;86(18):1659-67. doi: 10.1212/WNL.0000000000002646. Epub 2016 Mar 30.
PubMed 27029628Moura RCF, Santos C, Collange Grecco L, Albertini G, Cimolin V, Galli M, Oliveira C. Effects of a single session of transcranial direct current stimulation on upper limb movements in children with cerebral palsy: A randomized, sham-controlled study. Dev Neurorehabil. 2017 Aug;20(6):368-375. doi: 10.1080/17518423.2017.1282050. Epub 2017 Feb 25.
PubMed 28632467Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.
PubMed 27372845Ambrus GG, Al-Moyed H, Chaieb L, Sarp L, Antal A, Paulus W. The fade-in--short stimulation--fade out approach to sham tDCS--reliable at 1 mA for naive and experienced subjects, but not investigators. Brain Stimul. 2012 Oct;5(4):499-504. doi: 10.1016/j.brs.2011.12.001. Epub 2012 Feb 22.
PubMed 22405745Grohs MN, Craig BT, Kirton A, Dewey D. Effects of Transcranial Direct Current Stimulation on Motor Function in Children 8-12 Years With Developmental Coordination Disorder: A Randomized Controlled Trial. Front Hum Neurosci. 2020 Dec 11;14:608131. doi: 10.3389/fnhum.2020.608131. eCollection 2020.
PubMed 33362497
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS): A Therapeutic Intervention for Motor Impairments in Children With Developmental Coordination Disorder (DCD).
- ClinicalTrials.gov ID
- NCT03453983
- Acronym / sponsor ID
- REB18-0183
- Conditions
- Developmental Coordination Disorder
- Keywords
- Neurodevelopment, Pediatrics, Motor Learning, Brain Imaging, Neuroscience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 5 Mar 2018 (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.
Transcrainial direct current stimulation (tDCS) has become increasingly popular over the past decade. tDCS is a safe and well-studied form of non-invasive brain stimulation. The purpose of the current study is to see if tDCS can improve motor function in children with developmental coordination disorder.
Non-invasive brain stimulation is shown to positively affect motor performance in children with neurodevelopmental and/or neurological conditions. For example, tDCS improves hand motor function in children with paediatric stroke and cerebral palsy. The benefits of tDCS in developmental coordination disorder is unknown. The current study will assess children's motor performance before and after tDCS intervention.
Detailed description
Developmental Coordination Disorder (DCD) is a chronic neurodevelopmental disorder characterized by impairments in coordinated motor abilities. Affected individuals show differences in brain maturation and early motor development, negatively impacting performance on everyday living tasks such as writing and participation in sports. Currently, there are few evidence-based therapeutic interventions for individuals diagnosed with DCD, and most are time consuming with modest effect sizes [1]. There is a pressing need to develop efficient, effective interventions to improve motor performance in children with DCD, as impairments often last into adulthood and can negatively impact long-term physical and mental health as well as social and academic abilities.
The ability to enhance endogenous motor learning systems with non-invasive brain stimulation is now well established in adults [2, 3]. Research studies have demonstrated the same potential in the developing brain. For instance, tDCS can significantly enhance the acquisition of motor skills over a few brief training sessions in typically developing school aged children, with lasting effects [4]. Recent clinical trials in children with cerebral palsy and neonatal stroke also suggest therapeutic efficacy in children with motor impairment [5, 6, 7]. However, the use of tDCS in pediatric populations is limited [8]. As tDCS has been associated with improved motor outcomes in adults and children with motor impairment, it may be an effective intervention for children with DCD. This however has not been investigated.
Research Questions \& Objectives:
The current study will investigate the therapeutic benefits of tDCS in adolescents with DCD. The primary aim is to determine changes in motor skill acquisition and learning during a skill-training paradigm that is paired with anodal tDCS or sham tDCS. We hypothesize that when compared to the sham tDCS group, the treatment tDCS group will show enhanced motor learning on tests of motor functioning.
Secondarily we will also examine sensorimotor changes following tDCS intervention and pediatric brain stimulation safety/tolerability.
Methods:
A randomized, sham controlled clinical trial including a final sample of 30 school aged children diagnosed with DCD will be conducted. The current study will be using a well-supported stimulation protocol, utilized in children and adolescents in the absence of adverse side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The currently proposed study is a randomized, sham controlled clinical trial that includes 30 adolescents diagnosed with DCD. Participants will be randomized to one of two tDCS treatment groups.
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS Intervention Group | Experimental | Device: Transcrainial Direct Current Stimulation (tDCS)Transcrainial Direct Current Stimulation (tDCS): The right primary motor cortex will be localized and a saline soaked sponge electrode will be placed onto M1 with a second saline soaked sponge electrode placed on the contralateral supraorbital region. |
| Sham tDCS Intervention Group | Sham comparator | Device: Transcrainial Direct Current Stimulation (tDCS)Transcrainial Direct Current Stimulation (tDCS): The right primary motor cortex will be localized and a saline soaked sponge electrode will be placed onto M1 with a second saline soaked sponge electrode placed on the contralateral supraorbital region. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosed and documented DCD (including individuals with additional diagnoses of attention and/or learning disorders)
- Aged 10 to 15 years
- Right Handed
Key exclusion criteria (4 listed)
- Presence of implanted electrical devices, metallic implants, and/or irremovable metal objects (i.e., cardiac pacemakers, braces etc.)
- Pregnancy or possibility of pregnancy
- Diagnosed with a neuropsychiatric disorder such as autism spectrum disorder or chronic medical condition such as cerebral palsy or epilepsy
- Taking prescribed medications
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 |
|---|---|---|
| Transcrainial Direct Current Stimulation (tDCS)Transcranial direct current stimulation (tDCS) is a safe non-invasive form of brain stimulation, which modulates, through the application of weak direct current, cortical excitability. The applied subthreshold current passes through two externally placed electrodes, an anode and cathode. | Device | Anodal tDCS Intervention Group, Sham tDCS Intervention Group |
Primary outcome
Purdue Pegborad Test (PPT)
Time frame: 20 minutes
The PPT is a valid measure of fine motor coordination, hand dexterity, and motor learning skills, which consists of 4 subtests: left hand peg placement [PPTL], right hand peg placement [PPTR], bimanual peg placement [PPTLR], and bimanual assembly [PPTA]. The PPT peg placement subtests involve placing as many pins as possible into a pegboard during a 30 second interval. The total number of pegs, or pairs of pegs, placed are counted and scored. The PPT assembly subtest involved building as many copies of a demonstration structure using pins, pegs, and washers within a 60 second time period.
2 secondary outcomes
Jebsen-Taylor Test of Hand Function (JTT)
Time frame: 20 minutes
Serial Reaction Time Task (SRTT)
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Background: PubMed 23106530Smits-Engelsman BC, Blank R, van der Kaay AC, Mosterd-van der Meijs R, Vlugt-van den Brand E, Polatajko HJ, Wilson PH. Efficacy of interventions to improve motor performance in children with developmental coordination disorder: a combined systematic review and meta-analysis. Dev Med Child Neurol. 2013 Mar;55(3):229-37. doi: 10.1111/dmcn.12008. Epub 2012 Oct 29.
- Background: PubMed 19164589Reis J, Schambra HM, Cohen LG, Buch ER, Fritsch B, Zarahn E, Celnik PA, Krakauer JW. Noninvasive cortical stimulation enhances motor skill acquisition over multiple days through an effect on consolidation. Proc Natl Acad Sci U S A. 2009 Feb 3;106(5):1590-5. doi: 10.1073/pnas.0805413106. Epub 2009 Jan 21.
- Background: PubMed 24367333Goodwill AM, Reynolds J, Daly RM, Kidgell DJ. Formation of cortical plasticity in older adults following tDCS and motor training. Front Aging Neurosci. 2013 Dec 6;5:87. doi: 10.3389/fnagi.2013.00087. eCollection 2013.
- Background: PubMed 27166171Ciechanski P, Kirton A. Transcranial Direct-Current Stimulation Can Enhance Motor Learning in Children. Cereb Cortex. 2017 May 1;27(5):2758-2767. doi: 10.1093/cercor/bhw114.
- Background: PubMed 27927938Kirton A, Ciechanski P, Zewdie E, Andersen J, Nettel-Aguirre A, Carlson H, Carsolio L, Herrero M, Quigley J, Mineyko A, Hodge J, Hill M. Transcranial direct current stimulation for children with perinatal stroke and hemiparesis. Neurology. 2017 Jan 17;88(3):259-267. doi: 10.1212/WNL.0000000000003518. Epub 2016 Dec 7.
- Background: PubMed 27029628Kirton A, Andersen J, Herrero M, Nettel-Aguirre A, Carsolio L, Damji O, Keess J, Mineyko A, Hodge J, Hill MD. Brain stimulation and constraint for perinatal stroke hemiparesis: The PLASTIC CHAMPS Trial. Neurology. 2016 May 3;86(18):1659-67. doi: 10.1212/WNL.0000000000002646. Epub 2016 Mar 30.
- Background: PubMed 28632467Moura RCF, Santos C, Collange Grecco L, Albertini G, Cimolin V, Galli M, Oliveira C. Effects of a single session of transcranial direct current stimulation on upper limb movements in children with cerebral palsy: A randomized, sham-controlled study. Dev Neurorehabil. 2017 Aug;20(6):368-375. doi: 10.1080/17518423.2017.1282050. Epub 2017 Feb 25.
- Background: PubMed 27372845Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.
- Background: PubMed 22405745Ambrus GG, Al-Moyed H, Chaieb L, Sarp L, Antal A, Paulus W. The fade-in--short stimulation--fade out approach to sham tDCS--reliable at 1 mA for naive and experienced subjects, but not investigators. Brain Stimul. 2012 Oct;5(4):499-504. doi: 10.1016/j.brs.2011.12.001. Epub 2012 Feb 22.
- Derived from this study: PubMed 33362497Grohs MN, Craig BT, Kirton A, Dewey D. Effects of Transcranial Direct Current Stimulation on Motor Function in Children 8-12 Years With Developmental Coordination Disorder: A Randomized Controlled Trial. Front Hum Neurosci. 2020 Dec 11;14:608131. doi: 10.3389/fnhum.2020.608131. eCollection 2020.
- Individual participant dataSharing planned: No. Currently, there is no pre-determined plan to share any collected data with other researchers.
Related trials for Developmental Coordination Disorder
Not yet recruiting
Video-Assisted Core Stabilization Exercises in Children With Developmental Coordination Disorder
Developmental Coordination Disorder (DCD)
Enrolling by invitation
BEhavioral Health Stratified Treatment (BEST) Study for Youth With Intellectual and/or Developmental Disabilities (IDD)
Depression, Anxiety
Not yet recruitingObservational study
Wearable Sensor Toolkit for Infant Motor Development
Motor Delay, Infant Development
Not yet recruiting
Neuromotor Task Training in Autistic Children With Motor Difficulties
Autism Spectrum Disorder (ASD)
Enrolling by invitationObservational study
Investigating the Relationship Between Motor Challenges and Postural Stability in ASD
Autism Spectrum Disorder
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.
Deborah M Dewey, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcrainial Direct Current Stimulation (tDCS) in people with Developmental Coordination Disorder, run by University of Calgary at 1 site in Canada.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 25 Mar 2020. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Purdue Pegborad Test (PPT) (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03453983, which also lists 10 linked publications.
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 25 Mar 2020.