Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Does tDCS Improve Motor Learning in 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03453983
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Calgary

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Developmental Coordination Disorder Device: Transcrainial Direct Current Stimulation (tDCS) Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Masking Description:

Participants will not be informed of the stimulation group to which they are randomized. Both stimulation groups produce similar transient scalp sensations in participants and the sham protocol that will be used has been shown to be valid and ensures that participants are naïve to their assigned treatment group [9]. Participants will be asked which stimulation group they felt they took part in to ensure adequate blinding.

Outcomes assessors will be blinded. Offline video analysis will be used to score motor assessment performance. These videos will exclude all identifying information including the participant's face and their stimulation group.

Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS): A Therapeutic Intervention for Motor Impairments in Children With Developmental Coordination Disorder (DCD).
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Arm Intervention/treatment
Experimental: Anodal tDCS Intervention Group
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.
Device: 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.

Sham Comparator: Sham tDCS Intervention Group
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.
Device: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Jebsen-Taylor Test of Hand Function (JTT) [ Time Frame: 20 minutes ]
    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.

  2. Serial Reaction Time Task (SRTT) [ Time Frame: 20 minutes ]
    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.


Other Outcome Measures:
  1. KINARM [ Time Frame: 45 minutes ]
    Sensorimotor changes will be measured between baseline, post-training, and 6 week follow-up using the Kinesiological Instrument for Normal and Altered Reaching Movements (KINARM, BKIN Technologies Ltd, Ontario, Canada). The KINARM robot is a valid and reliable tool that can be used to measure children's proprioceptive, sensorimotor, visuomotor and motor decision/control abilities.



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:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed and documented DCD (including individuals with additional diagnoses of attention and/or learning disorders)
  • Aged 10 to 15 years
  • Right Handed

Exclusion Criteria:

  • 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

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): NCT03453983


Contacts
Layout table for location contacts
Contact: Melody N Grohs, MSc (587)220-7522 melody.grohs@ucalgary.ca
Contact: Deborah M Dewey, PhD (403)441-8468 dmdewey@ucalgary.ca

Locations
Layout table for location information
Canada, Alberta
Child Development Center, Owerko Centre Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: Administrative Coordinator    403-441-2814    lyndell.foltinek@ucalgary.ca   
Sub-Investigator: Melody N Grohs, MSc.         
Principal Investigator: Deborah M Dewey, PhD, RPsych         
Sponsors and Collaborators
University of Calgary
Investigators
Layout table for investigator information
Principal Investigator: Deborah M Dewey, PhD University of Calgary

Publications:

Layout table for additonal information
Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT03453983     History of Changes
Other Study ID Numbers: REB18-0183
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Currently, there is no pre-determined plan to share any collected data with other researchers.

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 Calgary:
Neurodevelopment
Pediatrics
Motor Learning
Brain Imaging
Neuroscience
Additional relevant MeSH terms:
Layout table for MeSH terms
Motor Skills Disorders
Neurodevelopmental Disorders
Mental Disorders