tDCS and Motor Learning in Children With DCD

NCT04490187 | Unknown

• 1 other identifier: H17-02513
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Children with a neurodevelopmental condition called developmental coordination disorder (DCD) struggle to learn motor skills and perform daily activities, such as tying shoelaces, printing, riding a bicycle, or playing sports. Evidence suggests that motor-based interventions combined with non-invasive brain stimulation to the motor cortex (transcranial direct-current stimulation, tDCS) has been effective in improving motor skills in children with cerebral palsy and other neurodevelopmental disorders, but few studies have examined tDCS in chidlren with DCD. The purpose of this randomized, blinded, sham-controlled interventional trial is to explore the effectiveness of anodal tDCS over M1 combined with a motor learning task in increasing motor skill learning in children with DCD.

Conditions

Developmental Coordination Disorder

Keywords

motor skills disorders; tDCS; task-specific intervention; occupational therapy

Outcome Measures

Primary Outcomes (1)

• Purdue Pegboard Test (Tiffin 1968)

  A standardized assessment that measures manual dexterity and bilateral coordination¬-the participants have 30 seconds to place pins into pegboard using their (1) right hand, (2) left hand, and (3) both hands, as well as another 30 seconds to assemble pins, washers and collars with both hands.

  Before and after intervention; 6 weeks after intervention

Secondary Outcomes (2)

• Bruininks-Oseretsky Test of Motor Proficiency-2 (BOT-2: Bruininks 2005) fine motor composite

  Before and after intervention; 6 weeks after intervention

• Evaluation Tool of Children's Handwriting (ETCH: Amundson 1995)

  Before and after intervention; 6 weeks after intervention

Other Outcomes (2)

• Conner's ADHD Index (Conners 2009)

  Before intervention

• tDCS Adverse Effects Questionnaire (Brunoni 2011)

  After each session of tDCS stimulation (active or sham) - daily for 3 consecutive days

Study Arms (2)

Active tDCS stimulation

EXPERIMENTAL

tDCS will be applied over the left motor cortex at 1 mA for 30 min. The current will be ramped up to 1 mA over 45-60 s, held for 30 min, and ramped down to 0 mA over 45-60 s.

Behavioral: Motor Learning

Sham tDCS stimulation

SHAM COMPARATOR

tDCS will be ramped up and held for only 60 s before it is slowly ramped down. This procedure, called the Fade-in-Short Stimulation-Fade out, has shown its reliability as an effective sham technique through making the same tolerability and transient scalp sensation as active stimulation in both adults (Ambrus 2012) and children (Ciechanski 2017).

Behavioral: Motor Learning

Interventions

Motor Learning BEHAVIORAL

Over three consecutive days, each child will perform five blocks of Purdue Pegboard Test: one block before, three blocks during, and one block after tDCS. Each block consists of three repetitions of Purdue Pegboard Test with the right hand. The children have to place pins into a pegboard as fast as they can in 30 seconds. It will take up to 10 minutes of brain stimulation time. After the Purdue Pegboard Test, each child will receive cognitive-based intervention for printing skills for 20 minutes while receiving tDCS. "Printing Like a Pro!" (Montgomery 2017) -a cognitive approach to teaching printing to primary school-age children-will be used to teach letters which each child has the most difficulty printing legibly as identified on a formal assessment of handwriting-ETCH (manuscript) (Amundson 1995).

Active tDCS stimulation; Sham tDCS stimulation

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• a score of ≤5th percentile in Manual Dexterity composite of the Movement Assessment Battery for Children-2 (MABC-2), as we are focusing on fine motor tasks in the study (Henderson 2007)
• meet DCD criteria on the DCD Questionnaire (Wilson 2007)
• right-handed as per the Edinburg Handedness Inventory (Oldfield 1971)

You may not qualify if:

• born preterm (gestation week\<37 weeks)
• diagnosed with any other neurodevelopmental disability such as Autism Spectrum Disorder (except ADHD)
• history of any neurological disorders
• taking any neuropsychiatric medications
• history of migraines
• having a scalp or skin condition (e.g., psoriasis or eczema)
• having a metallic implants (e.g., surgical clips or pacemaker)
• history of seizure or epilepsy

Sponsors & Collaborators

• University of British Columbia: lead
• University of Calgary: collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6H 3V4, Canada

RECRUITING

Related Publications (34)

• Reis 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.

  PMID: 19164589 BACKGROUND

• Ciechanski 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.

  PMID: 27166171 BACKGROUND

• Krishnan C, Santos L, Peterson MD, Ehinger M. Safety of noninvasive brain stimulation in children and adolescents. Brain Stimul. 2015 Jan-Feb;8(1):76-87. doi: 10.1016/j.brs.2014.10.012. Epub 2014 Oct 28.

  PMID: 25499471 BACKGROUND

• Reis J, Fritsch B. Modulation of motor performance and motor learning by transcranial direct current stimulation. Curr Opin Neurol. 2011 Dec;24(6):590-6. doi: 10.1097/WCO.0b013e32834c3db0.

  PMID: 21968548 BACKGROUND

• Gillick BT, Kirton A, Carmel JB, Minhas P, Bikson M. Pediatric stroke and transcranial direct current stimulation: methods for rational individualized dose optimization. Front Hum Neurosci. 2014 Sep 19;8:739. doi: 10.3389/fnhum.2014.00739. eCollection 2014.

  PMID: 25285077 BACKGROUND

• Grecco LA, Oliveira CS, Duarte NA, Lima VL, Zanon N, Fregni F. Cerebellar transcranial direct current stimulation in children with ataxic cerebral palsy: A sham-controlled, crossover, pilot study. Dev Neurorehabil. 2017 Apr;20(3):142-148. doi: 10.3109/17518423.2016.1139639. Epub 2016 Mar 22.

  PMID: 27003795 BACKGROUND

• Kirton 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.

  PMID: 27927938 BACKGROUND

• Moura RC, Santos CA, Grecco LA, Lazzari RD, Dumont AJ, Duarte NC, Braun LA, Lopes JB, Santos LA, Rodrigues EL, Albertini G, Cimolin V, Galli M, Oliveira CS. Transcranial direct current stimulation combined with upper limb functional training in children with spastic, hemiparetic cerebral palsy: study protocol for a randomized controlled trial. Trials. 2016 Aug 17;17(1):405. doi: 10.1186/s13063-016-1534-7.

  PMID: 27530758 BACKGROUND

• Muszkat D, Polanczyk GV, Dias TG, Brunoni AR. Transcranial Direct Current Stimulation in Child and Adolescent Psychiatry. J Child Adolesc Psychopharmacol. 2016 Sep;26(7):590-7. doi: 10.1089/cap.2015.0172. Epub 2016 Mar 30.

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• Amatachaya A, Auvichayapat N, Patjanasoontorn N, Suphakunpinyo C, Ngernyam N, Aree-Uea B, Keeratitanont K, Auvichayapat P. Effect of anodal transcranial direct current stimulation on autism: a randomized double-blind crossover trial. Behav Neurol. 2014;2014:173073. doi: 10.1155/2014/173073. Epub 2014 Oct 30.

  PMID: 25530675 BACKGROUND

• Bandeira ID, Guimaraes RS, Jagersbacher JG, Barretto TL, de Jesus-Silva JR, Santos SN, Argollo N, Lucena R. Transcranial Direct Current Stimulation in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD): A Pilot Study. J Child Neurol. 2016 Jun;31(7):918-24. doi: 10.1177/0883073816630083. Epub 2016 Feb 15.

  PMID: 26879095 BACKGROUND

• American Psychiatric Association. Diagnostic and statistical manual of mental disorders - 5th ed. (DSM-5). Washington, DC: American Psychiatric Association; 2013.

  BACKGROUND

• Zwicker JG, Harris SR, Klassen AF. Quality of life domains affected in children with developmental coordination disorder: a systematic review. Child Care Health Dev. 2013 Jul;39(4):562-80. doi: 10.1111/j.1365-2214.2012.01379.x. Epub 2012 Apr 20.

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• Kirby A, Sugden D, Purcell C. Diagnosing developmental coordination disorders. Arch Dis Child. 2014 Mar;99(3):292-6. doi: 10.1136/archdischild-2012-303569. Epub 2013 Nov 19.

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• Piek JP, Pitcher TM, Hay DA. Motor coordination and kinaesthesis in boys with attention deficit-hyperactivity disorder. Dev Med Child Neurol. 1999 Mar;41(3):159-65. doi: 10.1017/s0012162299000341.

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• Biotteau M, Chaix Y, Blais M, Tallet J, Peran P, Albaret JM. Neural Signature of DCD: A Critical Review of MRI Neuroimaging Studies. Front Neurol. 2016 Dec 16;7:227. doi: 10.3389/fneur.2016.00227. eCollection 2016.

  PMID: 28018285 BACKGROUND

• McLeod KR, Langevin LM, Goodyear BG, Dewey D. Functional connectivity of neural motor networks is disrupted in children with developmental coordination disorder and attention-deficit/hyperactivity disorder. Neuroimage Clin. 2014 Mar 26;4:566-75. doi: 10.1016/j.nicl.2014.03.010. eCollection 2014.

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• Henderson SE, Sugden DA, Barnett AL. Movement Assessment Battery for Children - 2nd ed. Psychological Corporation London; 2007.

  BACKGROUND

• Wilson, B.N., Kaplan, B.J., Crawford, S.G., & Roberts, G. (2007). Developmental Coordination Questionnaire 2007 (DCDQ'07). Available at:http://www.dcdq.ca.

  BACKGROUND

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• Tiffin J. Purdue pegboard test. Chicago: Scientific Research Associates. 1968.

  BACKGROUND

• Bruininks, R., & Bruininks, B. Bruininks-oseretsky test of motor proficiency. 2nd ed. Minneapolis, MN: NCS Pearson; 2005.

  BACKGROUND

• Montgomery, I. & Zwicker, J.G. Printing like a pro! http://www.childdevelopment.ca/Libraries/Handwriting/Printing_Like_a_Pro_-_For_School_Staff.sflb.ashx

  BACKGROUND

• Amundson, S. (1995). Evaluation tool of children's handwriting. Homer, AL: OT KIDS.

  BACKGROUND

• Soterix Medical. Soterix medical launches PainX tDCS treatment in canada with health canada approval. https://soterixmedical.com/newsroom/press/2016/09/soterix-medical-launches-painx-tdcs-treatment-in-canada/26.

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• Ambrus 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.

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• Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.

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MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jill G Zwicker, PhD, OT

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Izadi-Najafabadi, MSc

CONTACT

604-875-2345; saraizad@alumni.ubc.ca

Nur Eisma

CONTACT

604-875-2427; neisma@bcchr.ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to sham vs active stimulation groups. The outcomes assessor will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Children with DCD with be recruited and randomized to receive active stimulation or sham tDCS

Study Record Dates

• First Submitted: January 18, 2020
• First Posted: July 29, 2020
• Study Start: September 27, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)