Transcranial direct current stimulation and constraint-induced therapy in cerebral palsy: A randomized, blinded, sham-controlled clinical trial

Bernadette Gillick; Tonya Rich; Samuel Nemanich; Chao Ying Chen; Jeremiah Menk; Bryon Mueller; Mo Chen; Marcie Ward; Gregg Meekins; Tim Feyma; Linda Krach; Kyle Rudser

doi:10.1016/j.ejpn.2018.02.001

Transcranial direct current stimulation and constraint-induced therapy in cerebral palsy: A randomized, blinded, sham-controlled clinical trial

Bernadette Gillick, Tonya Rich, Samuel Nemanich, Chao Ying Chen, Jeremiah Menk, Bryon Mueller, Mo Chen, Marcie Ward, Gregg Meekins, Tim Feyma, Linda Krach, Kyle Rudser

Research output: Contribution to journal › Article › peer-review

58 Scopus citations

Abstract

We investigated the safety, feasibility, and efficacy of transcranial direct current stimulation (tDCS) combined with constraint-induced movement therapy (CIMT) in children and young adults with unilateral cerebral palsy. Twenty participants were randomized to receive active or sham tDCS. The intervention consisted of 10 consecutive weekday sessions of tDCS applied to the non-lesioned hemisphere (20 min) concurrently with CIMT (120 min). Participants, caregivers, and interventionists were blinded to group assignment. The primary safety outcome investigated adverse events. The primary behavioral outcome was the Assisting Hand Assessment. All 20 participants (mean age = 12.7 yrs, range = 7.4–21.6 years) were evaluated for the primary outcomes. No serious adverse events occurred, and the most commonly reported minor adverse events were headache and itchiness. Both groups demonstrated a significant improvement in hand function after the intervention, although no significant effect of tDCS was observed (between-group difference = −2.18, 95% CI = [−6.48, 2.12], p = 0.30). Although hand function improved overall, no significant differences between intervention groups were found. Children with preserved corticospinal tract circuitry from the lesioned hemisphere, compared to those without, showed greater improvement in hand function (mean difference = 3.04, 95% CI = [−0.64, 6.72], p = 0.099). Our study demonstrates the safety and feasibility of serial sessions of tDCS, and presents preliminary evidence for the effect of CST circuitry on outcomes following tDCS/CIMT. Future work in children with unilateral cerebral palsy should focus on the optimal dosing and consider individual brain circuitry when describing response to combined interventions. Clinical Trials Registration: Clinicaltrials.gov NCT 02250092.

Original language	English (US)
Pages (from-to)	358-368
Number of pages	11
Journal	European Journal of Paediatric Neurology
Volume	22
Issue number	3
DOIs	https://doi.org/10.1016/j.ejpn.2018.02.001
State	Published - May 2018

Bibliographical note

Funding Information:
Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health Award Number UL1TR000114 . The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The PI had full access to all the data in the study and had final responsibility for the decision to submit for publication. The authors thank the Center for Neurobehavioral Development and Center for Magnetic Resonance Imaging (P41 EB015894) at the University of Minnesota. We also thank the mentors, collaborators, therapists, therapy supervisors, study coordinators, and research administration personnel from Gillette Children's Specialty Healthcare. Most importantly, we are grateful for the energies of the families, caregivers and participants involved in this study.

Funding Information:
Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health Award Number UL1TR000114. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The PI had full access to all the data in the study and had final responsibility for the decision to submit for publication. The authors thank the Center for Neurobehavioral Development and Center for Magnetic Resonance Imaging (P41 EB015894) at the University of Minnesota. We also thank the mentors, collaborators, therapists, therapy supervisors, study coordinators, and research administration personnel from Gillette Children's Specialty Healthcare. Most importantly, we are grateful for the energies of the families, caregivers and participants involved in this study.

Funding Information:
This study was funded the National Institutes of Health (NIH) Eunice Kennedy Shriver National Institutes of Child Health and Development K01 Award ( HD078484-01A1 ), the Cerebral Palsy Foundation , the Foundation for Physical Therapy Magistro Family Grant, and Minnesota's Discovery, Research, and Innovation Economy (MnDRIVE) . The project described was also supported in part by Award UL1 TR000114 and KL2 TR000113 .

Publisher Copyright:
© 2018 European Paediatric Neurology Society

Keywords

Constraint-induced movement therapy
Rehabilitation
Transcranial direct current stimulation
Unilateral cerebral palsy

Publisher link

10.1016/j.ejpn.2018.02.001

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5899638

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Gillick, B., Rich, T., Nemanich, S., Chen, C. Y., Menk, J., Mueller, B., Chen, M., Ward, M., Meekins, G., Feyma, T., Krach, L., & Rudser, K. (2018). Transcranial direct current stimulation and constraint-induced therapy in cerebral palsy: A randomized, blinded, sham-controlled clinical trial. European Journal of Paediatric Neurology, 22(3), 358-368. https://doi.org/10.1016/j.ejpn.2018.02.001

Gillick, B, Rich, T, Nemanich, S, Chen, CY, Menk, J, Mueller, B, Chen, M, Ward, M, Meekins, G, Feyma, T, Krach, L & Rudser, K 2018, 'Transcranial direct current stimulation and constraint-induced therapy in cerebral palsy: A randomized, blinded, sham-controlled clinical trial', European Journal of Paediatric Neurology, vol. 22, no. 3, pp. 358-368. https://doi.org/10.1016/j.ejpn.2018.02.001

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abstract = "We investigated the safety, feasibility, and efficacy of transcranial direct current stimulation (tDCS) combined with constraint-induced movement therapy (CIMT) in children and young adults with unilateral cerebral palsy. Twenty participants were randomized to receive active or sham tDCS. The intervention consisted of 10 consecutive weekday sessions of tDCS applied to the non-lesioned hemisphere (20 min) concurrently with CIMT (120 min). Participants, caregivers, and interventionists were blinded to group assignment. The primary safety outcome investigated adverse events. The primary behavioral outcome was the Assisting Hand Assessment. All 20 participants (mean age = 12.7 yrs, range = 7.4–21.6 years) were evaluated for the primary outcomes. No serious adverse events occurred, and the most commonly reported minor adverse events were headache and itchiness. Both groups demonstrated a significant improvement in hand function after the intervention, although no significant effect of tDCS was observed (between-group difference = −2.18, 95% CI = [−6.48, 2.12], p = 0.30). Although hand function improved overall, no significant differences between intervention groups were found. Children with preserved corticospinal tract circuitry from the lesioned hemisphere, compared to those without, showed greater improvement in hand function (mean difference = 3.04, 95% CI = [−0.64, 6.72], p = 0.099). Our study demonstrates the safety and feasibility of serial sessions of tDCS, and presents preliminary evidence for the effect of CST circuitry on outcomes following tDCS/CIMT. Future work in children with unilateral cerebral palsy should focus on the optimal dosing and consider individual brain circuitry when describing response to combined interventions. Clinical Trials Registration: Clinicaltrials.gov NCT 02250092.",

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author = "Bernadette Gillick and Tonya Rich and Samuel Nemanich and Chen, {Chao Ying} and Jeremiah Menk and Bryon Mueller and Mo Chen and Marcie Ward and Gregg Meekins and Tim Feyma and Linda Krach and Kyle Rudser",

note = "Funding Information: Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health Award Number UL1TR000114 . The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The PI had full access to all the data in the study and had final responsibility for the decision to submit for publication. The authors thank the Center for Neurobehavioral Development and Center for Magnetic Resonance Imaging (P41 EB015894) at the University of Minnesota. We also thank the mentors, collaborators, therapists, therapy supervisors, study coordinators, and research administration personnel from Gillette Children's Specialty Healthcare. Most importantly, we are grateful for the energies of the families, caregivers and participants involved in this study. Funding Information: Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health Award Number UL1TR000114. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The PI had full access to all the data in the study and had final responsibility for the decision to submit for publication. The authors thank the Center for Neurobehavioral Development and Center for Magnetic Resonance Imaging (P41 EB015894) at the University of Minnesota. We also thank the mentors, collaborators, therapists, therapy supervisors, study coordinators, and research administration personnel from Gillette Children's Specialty Healthcare. Most importantly, we are grateful for the energies of the families, caregivers and participants involved in this study. Funding Information: This study was funded the National Institutes of Health (NIH) Eunice Kennedy Shriver National Institutes of Child Health and Development K01 Award ( HD078484-01A1 ), the Cerebral Palsy Foundation , the Foundation for Physical Therapy Magistro Family Grant, and Minnesota's Discovery, Research, and Innovation Economy (MnDRIVE) . The project described was also supported in part by Award UL1 TR000114 and KL2 TR000113 . Publisher Copyright: {\textcopyright} 2018 European Paediatric Neurology Society",

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AU - Gillick, Bernadette

AU - Rich, Tonya

AU - Nemanich, Samuel

AU - Chen, Chao Ying

AU - Menk, Jeremiah

AU - Mueller, Bryon

AU - Chen, Mo

AU - Ward, Marcie

AU - Meekins, Gregg

AU - Feyma, Tim

AU - Krach, Linda

AU - Rudser, Kyle

N1 - Funding Information: Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health Award Number UL1TR000114 . The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The PI had full access to all the data in the study and had final responsibility for the decision to submit for publication. The authors thank the Center for Neurobehavioral Development and Center for Magnetic Resonance Imaging (P41 EB015894) at the University of Minnesota. We also thank the mentors, collaborators, therapists, therapy supervisors, study coordinators, and research administration personnel from Gillette Children's Specialty Healthcare. Most importantly, we are grateful for the energies of the families, caregivers and participants involved in this study. Funding Information: Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health Award Number UL1TR000114. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The PI had full access to all the data in the study and had final responsibility for the decision to submit for publication. The authors thank the Center for Neurobehavioral Development and Center for Magnetic Resonance Imaging (P41 EB015894) at the University of Minnesota. We also thank the mentors, collaborators, therapists, therapy supervisors, study coordinators, and research administration personnel from Gillette Children's Specialty Healthcare. Most importantly, we are grateful for the energies of the families, caregivers and participants involved in this study. Funding Information: This study was funded the National Institutes of Health (NIH) Eunice Kennedy Shriver National Institutes of Child Health and Development K01 Award ( HD078484-01A1 ), the Cerebral Palsy Foundation , the Foundation for Physical Therapy Magistro Family Grant, and Minnesota's Discovery, Research, and Innovation Economy (MnDRIVE) . The project described was also supported in part by Award UL1 TR000114 and KL2 TR000113 . Publisher Copyright: © 2018 European Paediatric Neurology Society

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Transcranial direct current stimulation and constraint-induced therapy in cerebral palsy: A randomized, blinded, sham-controlled clinical trial

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