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Enhancing Motor Plasticity After Perinatal Stroke Using tDCS (tDCS)

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ClinicalTrials.gov Identifier: NCT02170285
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
Adam Kirton, University of Calgary

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.


Condition or disease Intervention/treatment Phase
Perinatal Stroke Cerebral Palsy Device: Interventional TDCS Device: Sham TDCS Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Developmental Motor Plasticity After Perinatal Stroke With Transcranial Direct Current Stimulation
Study Start Date : May 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interventional tDCS
The primary intervention will be cathodal (inhibitory) tDCS (see below).
Device: Interventional TDCS
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.
Other Name: DC stimulator (neuroConn GmbH, GE)

Sham Comparator: Sham tDCS
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
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.




Primary Outcome Measures :
  1. Change from baseline in the Assisting Hand Assessment (AHA) at 8 weeks [ Time Frame: 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.


Secondary Outcome Measures :
  1. tDCS Safety and Tolerability evaluation (TST) [ Time Frame: Each day following the tDCS treatment (10x) ]
    Adapted from a published safety consensus statements and child-friendly tolerability evaluations for non-invasive brain stimulation. Measure will capture all possible adverse events including severity and duration, rank tDCS sessions across common childhood experiences, and evaluate sham effectiveness. For more details about this measures please refer to the published literature.

  2. Change from baseline in the Canadian Occupational Performance Measure (COPM) at 1 week [ Time Frame: Baseline, 1 week ]
    Individualized, family-centered tool identifying child and family-perceived difficulties in self-care, productivity (school), and activities. OT-guided goal setting scores 3-5 individualized, realistic goals and ranks them on a scale of 1-10 for both satisfaction and performance. The same assessor applies the tool at post follow-ups without reminding the subject of previous scores. Such subjective measures are highly clinically relevant to assess perceived gains in children. COPM is validated for our population.

  3. Change from baseline in the Canadian Occupational Performance Measure (COPM) at 8 weeks [ Time Frame: 8 weeks ]
    Individualized, family-centered tool identifying child and family-perceived difficulties in self-care, productivity (school), and activities. OT-guided goal setting scores 3-5 individualized, realistic goals and ranks them on a scale of 1-10 for both satisfaction and performance. The same assessor applies the tool at post follow-ups without reminding the subject of previous scores. Such subjective measures are highly clinically relevant to assess perceived gains in children. COPM is validated for our population.


Other Outcome Measures:
  1. Change from baseline function in the Jebsen Taylor Test of Hand Function (JTTHF) at 1 week [ Time Frame: Baseline, 1 week ]
    Standardized timed test of unimanual upper extremity functional activities evaluating efficiency of movement. For more details about this measures please refer to the published literature.

  2. Change in grip and pinch strength (GS, PS) (bilateral) at 1 week from baseline [ Time Frame: Baseline, 1 week ]
    Simple measures of motor power, quantifiable with hand dynamometer and pinch meter. Main function is independent assessment of UNAFFECTED hand function to ensure no decline in function.

  3. Change from baseline using the Box and blocks and Purdue pegboard tests daily during the trial [ Time Frame: Baseline, daily during trial at start and end of session (20x) ]
    Box and blocks evaluates manual dexterity with a quick, functional relevant test with robust range applicable to this age range. Main purpose is to gauge daily motor learning effects. The Purdue pegboard test will serve a similar function with comparability to recent pediatric CIMT studies (not performed daily).

  4. Change from baseline in the Melbourne Assessment of Unilateral Upper Limb Function (MAUULF) at 1 week [ Time Frame: Baseline, 1 week ]
    Validated, criterion-referenced unimanual functional measure designed to detect therapeutic change in children with hemiparetic CP. High reliabilities and construct validity. For more details about this measures please refer to the published literature.

  5. Change from baseline in the Quality of Life (QoL) assessment at 1 week [ Time Frame: Baseline, 1 week ]
    Functional improvements may not correlate with health related QoL, necessitating evaluation in clinical trials. The CP QOL-Child is a psychometrically sound, condition specific instrument for children with CP (age 4-12). The Pediatric Quality of Life Inventory CP Module (PedsQL-CP) is condition specific and validated for child self-report (age 5-18) and will be completed by all participants. These tools will evaluate social and emotional well-being, participation, school activities, access to services, pain and feelings about disability, and family health.

  6. Change from baseline in TMS Neurophysiology at 1 week [ Time Frame: Baseline, 1 week ]
    Single and paired pulse TMS paradigms will evaluate subject motor neurophysiology including the following parameters from stroke and non-stroke hemispheres: RMT, AMT, stimulus-response curves, SICI, ICF, LICI, IHI, cSP, iSP.

  7. Pre and post intervention Advanced Neuroimaging [ Time Frame: Baseline, 1 week ]
    Standardized 3T MR protocol will be applied including anatomical volumetrics, task fMRI (affected, unaffected, and bimanual hand activations), resting state fMRI (primary outcome is M1 laterality index), diffusion tensor imaging (primary outcome is CST FA ratio) and bilateral M1 MR spectroscopy.

  8. Change from baseline function in the Jebsen Taylor Test of Hand Function (JTTHF) at 8 weeks [ Time Frame: 8 weeks ]
    Standardized timed test of unimanual upper extremity functional activities evaluating efficiency of movement. For more details about this measures please refer to the published literature.

  9. Change in grip and pinch strength (GS, PS) (bilateral) at 8 weeks from baseline [ Time Frame: 8 weeks ]
    Simple measures of motor power, quantifiable with hand dynamometer and pinch meter. Main function is independent assessment of UNAFFECTED hand function to ensure no decline in function.

  10. Change from baseline using the Box and blocks and Purdue pegboard at 8 weeks [ Time Frame: 8 weeks ]
    Box and blocks evaluates manual dexterity with a quick, functional relevant test with robust range applicable to this age range. Main purpose is to gauge daily motor learning effects. The Purdue pegboard test will serve a similar function with comparability to recent pediatric CIMT studies (not performed daily).

  11. Change from baseline in the Melbourne Assessment of Unilateral Upper Limb Function (MAUULF) at 8 weeks [ Time Frame: 8 weeks ]
    Validated, criterion-referenced unimanual functional measure designed to detect therapeutic change in children with hemiparetic CP. High reliabilities and construct validity. For more details about this measures please refer to the published literature.

  12. Change from baseline in the Quality of Life (QoL) assessment at 8 weeks [ Time Frame: 8 weeks ]
    Functional improvements may not correlate with health related QoL, necessitating evaluation in clinical trials. The CP QOL-Child is a psychometrically sound, condition specific instrument for children with CP (age 4-12). The Pediatric Quality of Life Inventory CP Module (PedsQL-CP) is condition specific and validated for child self-report (age 5-18) and will be completed by all participants. These tools will evaluate social and emotional well-being, participation, school activities, access to services, pain and feelings about disability, and family health.



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT02170285


Locations
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Adam Kirton, MD, MSc University of Calgary

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Adam Kirton, Associate Professor, Pediatrics and Clinical Neurosciences, University of Calgary
ClinicalTrials.gov Identifier: NCT02170285     History of Changes
Other Study ID Numbers: E24720
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Adam Kirton, University of Calgary:
perinatal stroke
hemiparetic cerebral palsy
brain stimulation
tDCS
constraint-induced movement therapy
hand arm bimanual intensive therapy

Additional relevant MeSH terms:
Stroke
Cerebral Palsy
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Damage, Chronic