NCT02170285

Brief Summary

The purpose of this study is to test tDCS (transcranial direct current stimulation), a type of non-invasive brain stimulation, to determine whether it can improve motor function in children with perinatal stroke and hemiparesis. Children 6-18 years with imaging-confirmed perinatal stroke and functional motor impairment will be recruited. Children will be randomized (1:1) to receive sham or tDCS (20 minutes daily) during daily intensive, goal-directed motor learning therapy (90 minutes). Motor outcomes will be repeated at baseline, 1 week, and 2 months. Aim 1: Establish the ability of tDCS to safely enhance motor learning in children with perinatal stroke. Hypothesis 1: tDCS is safe and well tolerated in children. Hypothesis 2: Contralesional, cathodal tDCS increases motor functional gains measured by AHA at 2 months in children with perinatal stroke.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

11 months

First QC Date

June 16, 2014

Last Update Submit

May 27, 2015

Conditions

Perinatal StrokeCerebral Palsy

Keywords

perinatal strokehemiparetic cerebral palsybrain stimulationtDCSconstraint-induced movement therapyhand arm bimanual intensive therapy

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the Assisting Hand Assessment (AHA) at 8 weeks

    This is the established standard for the objective quantification of bilateral hand function in children with hemiparetic CP.This Rasch-built evaluation carries the strongest evidence of inter-rater, intra-rater, and test-retest reliabilities, test-validity, and responsiveness to change for bimanual tasks in children within our age range For more details about this measures please refer to the published literature.

    8 weeks

Secondary Outcomes (3)

  • tDCS Safety and Tolerability evaluation (TST)

    Each day following the tDCS treatment (10x)

  • Change from baseline in the Canadian Occupational Performance Measure (COPM) at 1 week

    Baseline, 1 week

  • Change from baseline in the Canadian Occupational Performance Measure (COPM) at 8 weeks

    8 weeks

Other Outcomes (12)

  • Change from baseline function in the Jebsen Taylor Test of Hand Function (JTTHF) at 1 week

    Baseline, 1 week

  • Change in grip and pinch strength (GS, PS) (bilateral) at 1 week from baseline

    Baseline, 1 week

  • Change from baseline using the Box and blocks and Purdue pegboard tests daily during the trial

    Baseline, daily during trial at start and end of session (20x)

  • +9 more other outcomes

Study Arms (2)

Interventional tDCS

EXPERIMENTAL

The primary intervention will be cathodal (inhibitory) tDCS (see below).

Device: Interventional TDCS

Sham tDCS

SHAM COMPARATOR

Sham subjects will undergo exactly the same tDCS protocol as outlined above. This includes the initial stimulation sequence, generating the initial transient scalp sensations identical to the treatment group. The stimulator will be programmed by the technologist to automatically ramp down to off over 30 seconds after 120 seconds of stimulation.

Device: Sham TDCS

Interventions

Interventional TDCSDEVICE

The primary intervention will be cathodal (inhibitory) tDCS over non-lesioned M1. This will be targeted using TMS baseline mapping data and neuronavigation (Brainsight2, Rogue Research, Montreal) individualized to the subjects MRI. Soft, replaceable 25cm2 electrodes will be placed over clean, dry scalp with the cathode over marked M1 and the reference electrode over contralateral forehead/orbit consistent with standard protocols. The current-controlled DC stimulator (neuroConn GmbH, Ilmenau, GE) will be turned up slowly over 30 seconds to the treatment current of 1.0 mA. TDCS will be administered each day during the first 20 minutes of the 90 minute therapy session. Child, family, and both treating and measuring occupational therapists are blinded to treatment allocation.

Also known as: DC stimulator (neuroConn GmbH, GE)
Interventional tDCS
Sham TDCSDEVICE

Sham subjects will undergo exactly the same tDCS protocol as outlined above. This includes the initial stimulation sequence, generating the initial transient scalp sensations identical to the treatment group. The stimulator will be programmed by the technologist to automatically ramp down to off over 30 seconds after 120 seconds of stimulation.

Sham tDCS

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Symptomatic hemiparetic CP (Pediatric Stroke Outcome Measure (PSOM) \>0.5) AND Manual Abilities Classification System (MACS) grade I-IV AND child/parent perceived limitations
  • Clinical and MRI-confirmed perinatal stroke syndrome (NAIS, APPIS, PVI)
  • Active wrist extension \>20 degrees, finger extension \>10 degrees
  • Can lift the affected arm 15 cm above a table surface and grasp light objects
  • Term birth (\>36 weeks) and current age 6 - 18 years
  • Informed consent

You may not qualify if:

  • Other neurological disorder not related to perinatal stroke
  • Multifocal perinatal stroke
  • Severe hemiparesis (no voluntary contraction in paretic hand, MACS level V)
  • Severe spasticity in the affected limb (Modified Ashworth Scale \>3)
  • Severe developmental delay or other inability to comply with study protocol
  • Unstable epilepsy (\>1 seizure/month or \>2 medication changes last 6 months)
  • Any TMS or MRI contraindication including implanted electronic devices
  • Botox, orthopedic surgery, or other invasive therapy in past 12 months
  • Constraint, brain stimulation or other modulatory therapy in past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Related Publications (1)

  • 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: 27927938DERIVED

Related Links

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Adam Kirton, MD, MSc

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Pediatrics and Clinical Neurosciences

Study Record Dates

First Submitted

June 16, 2014

First Posted

June 23, 2014

Study Start

May 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

CA(1)