Single-session tDCS in Cerebral Palsy

NCT03635775 | Completed Results FDA Device

• 3 other identifiers: STUDY00002820P2CHD086844K01HD078484
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to characterize individual responses to a single application of transcranial direct current stimulation (tDCS) in children with unilateral cerebral palsy (UCP), and to test which electrode configuration produces changes in brain excitability and motor function. Participants with UCP, ages 7-21 years, will be assigned to one of four tDCS groups. Using single-pulse transcranial magnetic stimulation, the investigators will assess cortical excitability before and at regular intervals up to 1 hour following tDCS. The knowledge gained from this study will advance the field through more targeted approaches of neuromodulatory techniques in this population and others, using individual characteristics to guide optimal treatment

Conditions

Cerebral Palsy; Perinatal Stroke; Periventricular Leukomalacia

Keywords

non-invasive brain stimulation; rehabilitation; pediatrics

Outcome Measures

Primary Outcomes (1)

• Change in Motor Evoked Potential Amplitude

  Motor evoked potential is a measure of cortical excitability using transcranial magnetic stimulation. MEP is measured as the amplitude of electrical activity from finger muscles. Outcome is reported as the percent change in MEP amplitude from pre-intervention to immediately post-intervention.

  approximately 5 minutes

Secondary Outcomes (1)

• Change in Movement Accuracy

  Approximately 1 hours

Study Arms (4)

Anodal ipsilesional Active tDCS

EXPERIMENTAL

Anodal tDCS (excitatory) applied to the lesioned hemisphere. Participant must have lesioned hemisphere MEP.

Device: Active tDCS

Cathodal contralesional Active tDCS

EXPERIMENTAL

Cathodal tDCS (inhibitory) applied to the non-lesioned hemisphere. Participant must have lesioned hemisphere MEP.

Device: Active tDCS

Anodal contralesional Active tDCS

EXPERIMENTAL

Anodal tDCS (excitatory) applied to the non-lesioned hemisphere. Participant must not have lesioned hemisphere MEP.

Device: Active tDCS

Sham tDCS

SHAM COMPARATOR

Sham tDCS applied in one of the above configurations

Device: Sham tDCS

Interventions

Active tDCS DEVICE

Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges.

Also known as: transcranial direct current stimulation

Anodal contralesional Active tDCS; Anodal ipsilesional Active tDCS; Cathodal contralesional Active tDCS

Sham tDCS DEVICE

Sham-setting--no electrical current delivered.

Sham tDCS

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages 7-21
• Able to follow two-step commands.
• Presence of an MEP in the non-lesioned hemisphere

You may not qualify if:

• Evidence of seizure within 2 years
• Other neurological or metabolic conditions
• Is pregnant (females only)
• Presence of indwelling metal in the head (e.g. aneurysm clip) or medical device.
• Clinical diagnosis of unilateral cerebral palsy
• Radiological evidence of stroke or periventricular leukomalacia
• Treatment with injectable agents (e.g. Botox) for spasticity management within 2 months

Sponsors & Collaborators

• University of Minnesota: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Samuel Nemanich

Minneapolis, Minnesota, 55407, United States

Location

Related Publications (21)

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  PMID: 21803933 BACKGROUND

• Figlewski K, Blicher JU, Mortensen J, Severinsen KE, Nielsen JF, Andersen H. Transcranial Direct Current Stimulation Potentiates Improvements in Functional Ability in Patients With Chronic Stroke Receiving Constraint-Induced Movement Therapy. Stroke. 2017 Jan;48(1):229-232. doi: 10.1161/STROKEAHA.116.014988. Epub 2016 Nov 29.

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• Duque J, Hummel F, Celnik P, Murase N, Mazzocchio R, Cohen LG. Transcallosal inhibition in chronic subcortical stroke. Neuroimage. 2005 Dec;28(4):940-6. doi: 10.1016/j.neuroimage.2005.06.033. Epub 2005 Aug 9.

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• Murase N, Duque J, Mazzocchio R, Cohen LG. Influence of interhemispheric interactions on motor function in chronic stroke. Ann Neurol. 2004 Mar;55(3):400-9. doi: 10.1002/ana.10848.

  PMID: 14991818 BACKGROUND

• Zewdie E, Damji O, Ciechanski P, Seeger T, Kirton A. Contralesional Corticomotor Neurophysiology in Hemiparetic Children With Perinatal Stroke. Neurorehabil Neural Repair. 2017 Mar;31(3):261-271. doi: 10.1177/1545968316680485. Epub 2016 Nov 24.

  PMID: 27885162 BACKGROUND

• Kirton A, Deveber G, Gunraj C, Chen R. Cortical excitability and interhemispheric inhibition after subcortical pediatric stroke: plastic organization and effects of rTMS. Clin Neurophysiol. 2010 Nov;121(11):1922-9. doi: 10.1016/j.clinph.2010.04.021.

  PMID: 20537584 BACKGROUND

• Collange Grecco LA, de Almeida Carvalho Duarte N, Mendonca ME, Galli M, Fregni F, Oliveira CS. Effects of anodal transcranial direct current stimulation combined with virtual reality for improving gait in children with spastic diparetic cerebral palsy: a pilot, randomized, controlled, double-blind, clinical trial. Clin Rehabil. 2015 Dec;29(12):1212-23. doi: 10.1177/0269215514566997. Epub 2015 Jan 20.

  PMID: 25604912 BACKGROUND

• Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27;57(10):1899-901. doi: 10.1212/wnl.57.10.1899.

  PMID: 11723286 BACKGROUND

• Gillick BT, Krach LE, Feyma T, Rich TL, Moberg K, Thomas W, Cassidy JM, Menk J, Carey JR. Primed low-frequency repetitive transcranial magnetic stimulation and constraint-induced movement therapy in pediatric hemiparesis: a randomized controlled trial. Dev Med Child Neurol. 2014 Jan;56(1):44-52. doi: 10.1111/dmcn.12243. Epub 2013 Aug 21.

  PMID: 23962321 BACKGROUND

• Kirton A, Chen R, Friefeld S, Gunraj C, Pontigon AM, Deveber G. Contralesional repetitive transcranial magnetic stimulation for chronic hemiparesis in subcortical paediatric stroke: a randomised trial. Lancet Neurol. 2008 Jun;7(6):507-13. doi: 10.1016/S1474-4422(08)70096-6. Epub 2008 May 1.

  PMID: 18455961 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

• 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

• Bikson M, Grossman P, Zannou AL, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Response to letter to the editor: Safety of transcranial direct current stimulation: Evidence based update 2016. Brain Stimul. 2017 Sep-Oct;10(5):986-987. doi: 10.1016/j.brs.2017.06.007. Epub 2017 Jul 12. No abstract available.

  PMID: 28734680 BACKGROUND

• Giacobbe V, Krebs HI, Volpe BT, Pascual-Leone A, Rykman A, Zeiarati G, Fregni F, Dipietro L, Thickbroom GW, Edwards DJ. Transcranial direct current stimulation (tDCS) and robotic practice in chronic stroke: the dimension of timing. NeuroRehabilitation. 2013;33(1):49-56. doi: 10.3233/NRE-130927.

  PMID: 23949028 BACKGROUND

• Lazzari RD, Politti F, Santos CA, Dumont AJ, Rezende FL, Grecco LA, Braun Ferreira LA, Oliveira CS. Effect of a single session of transcranial direct-current stimulation combined with virtual reality training on the balance of children with cerebral palsy: a randomized, controlled, double-blind trial. J Phys Ther Sci. 2015 Mar;27(3):763-8. doi: 10.1589/jpts.27.763. Epub 2015 Mar 31.

  PMID: 25931726 BACKGROUND

• Gillick BT, Feyma T, Menk J, Usset M, Vaith A, Wood TJ, Worthington R, Krach LE. Safety and feasibility of transcranial direct current stimulation in pediatric hemiparesis: randomized controlled preliminary study. Phys Ther. 2015 Mar;95(3):337-49. doi: 10.2522/ptj.20130565. Epub 2014 Nov 20.

  PMID: 25413621 BACKGROUND

• Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19.

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• 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

• Gillick B, Rich T, Nemanich S, Chen CY, Menk J, Mueller B, Chen M, Ward M, Meekins G, Feyma T, Krach L, Rudser K. Transcranial direct current stimulation and constraint-induced therapy in cerebral palsy: A randomized, blinded, sham-controlled clinical trial. Eur J Paediatr Neurol. 2018 May;22(3):358-368. doi: 10.1016/j.ejpn.2018.02.001. Epub 2018 Feb 11.

  PMID: 29456128 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Leukomalacia, Periventricular

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders; Encephalomalacia; Vascular Diseases; Cardiovascular Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Bernadette Gillick
• Organization: University of Wisconsin Madison

bgillick@wisc.edu

612-625-3645

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and families will be masked to intervention group. The research team members performing assessments will be masked to intervention group.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: August 17, 2018
• Study Start: May 1, 2018
• Primary Completion: February 21, 2020
• Study Completion: February 21, 2020
• Last Updated: April 13, 2021
• Results First Posted: February 25, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)