Stroke Clinical Trial
— PLASTIC CHAMPSOfficial title:
Modulation of Brain Plasticity After Perinatal Stroke: The PLASTIC CHAMPS Trial
Verified date | October 2013 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Newborn stroke is the leading cause of a common type of cerebral palsy (CP) that affects
thousands of Canadian children and families. Treatments for CP are generally ineffective, and
have traditionally focused on the weak body rather than the injured brain. Understanding how
the newborn brain responds to injuries like stroke (plasticity) carries the greatest
potential for better treatments. We propose to study the ability of two interventions to
modulate brain plasticity toward better function in children with stroke-induced CP. One is a
rehabilitation method called constraint-induced movement therapy (CIMT), the other is a type
of non-invasive brain stimulation called transcranial magnetic stimulation (TMS). TMS is safe
and comfortable for children and we recently showed it could improve motor function in
children with stroke.
We will perform a special study to test both treatments simultaneously. Children 7-18 years
with stroke-induced CP will be recruited into the study from across Alberta. Each child will
randomly receive either TMS, CIMT, both, or neither each day for two weeks while attending
our new HemiKids Power Camp for motor learning. Improvements will be measured by trained
therapists over 1 year. TMS will also measure brain plasticity, both initially and following
treatment. Our lead investigator is an expert in both newborn stroke and TMS and has
assembled an experienced team of accomplished collaborators to ensure the completion of this
important work. This will be the largest study of children with CP examined in this manner.
This will be the first clinical trial of non-invasive brain stimulation (TMS) in CP, the
largest trial of CIMT (and the first exclusive to newborn stroke), and the first study
allowing the direct comparison of two different therapies. In establishing the first
dedicated pediatric TMS laboratory in Canada, we will be the first to measure plasticity
changes in newborn stroke, advancing new treatments of this previously untreatable and
disabling disease.
Patient recruitment is currently underway at Alberta Children's Hospital. Application is
currently underway to expand recruitment to Northern Alberta through the Glenrose
Rehabilitation Hospital and Stollery Children's Hospital, to enable patients from Northern
Alberta greater opportunity to participate as subjects in this study.
Status | Unknown status |
Enrollment | 64 |
Est. completion date | March 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 18 Years |
Eligibility |
Inclusion criteria: 1. Symptomatic hemiplegic CP with impairment(s) of the upper extremity including the hand (Pediatric Stroke Outcome Measure motor >0.5; AND Manual Ability Classification System I, II,III, or IV; AND both child and parent perceive functional limitations (able to identify personally meaningful deficits in function). 2. MRI confirmed AIS-MCA or PVI (neuroradiological syndrome classified by two blinded, experienced investigators according to previously validated methods) 3. Age at enrollment: 6-18 years 4. Resident in province of Alberta for period of study 5. Informed consent/assent Exclusion criteria: 1. Multifocal perinatal stroke or other brain injury/abnormality 2. Severe hemiparesis (no voluntary contraction in paretic hand, MACS level V) 3. Intellectual disability causing an inability to comply with study protocol 4. Unstable epilepsy (>1 seizure/month or >2 medication changes (dose or agent) in the last 6 months or history of recurrent status epilepticus) 5. Any TMS contraindication including implanted electronic devices 6. Botulinum toxin A injection in the affected upper extremity within the preceding 6 months 7. Orthopedic surgery in the affected upper extremity in the previous 12 months 8. Unwilling to delay any new therapeutic rehabilitational intervention directed towards upper limb function (aside from study home program) for the 6 month duration of the study |
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Childrens Hospital | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | Heart and Stroke Foundation of Canada, University of Alberta |
Canada,
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. — View Citation
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. — View Citation
Kirton A, Deveber G, Pontigon AM, Macgregor D, Shroff M. Presumed perinatal ischemic stroke: vascular classification predicts outcomes. Ann Neurol. 2008 Apr;63(4):436-43. doi: 10.1002/ana.21334. — View Citation
Kirton A, deVeber G. Advances in perinatal ischemic stroke. Pediatr Neurol. 2009 Mar;40(3):205-14. doi: 10.1016/j.pediatrneurol.2008.09.018. Review. — View Citation
Kirton A, Shroff M, Pontigon AM, deVeber G. Risk factors and presentations of periventricular venous infarction vs arterial presumed perinatal ischemic stroke. Arch Neurol. 2010 Jul;67(7):842-8. doi: 10.1001/archneurol.2010.140. — View Citation
Kirton A, Wei X. Teaching neuroimages: confirmation of prenatal periventricular venous infarction with susceptibility-weighted MRI. Neurology. 2010 Mar 23;74(12):e48. doi: 10.1212/WNL.0b013e3181d5a47a. — View Citation
Kirton A, Westmacott R, deVeber G. Pediatric stroke: rehabilitation of focal injury in the developing brain. NeuroRehabilitation. 2007;22(5):371-82. Review. — View Citation
Raju TN, Nelson KB, Ferriero D, Lynch JK; NICHD-NINDS Perinatal Stroke Workshop Participants. Ischemic perinatal stroke: summary of a workshop sponsored by the National Institute of Child Health and Human Development and the National Institute of Neurological Disorders and Stroke. Pediatrics. 2007 Sep;120(3):609-16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Canadian Occupational Performance Measure (COPM). | The COPM is an individualized, family-centered tool designed to guide participants to identify self-perception of difficulties in self-care, productivity (i.e school) and leisure activities. | Completed 2 weeks or less before treatment day 1 | |
Primary | Canadian Occupational Performance Measure (COPM) | The COPM is an individualized, family-centered tool designed to guide participants to identify self-perception of difficulties in self-care, productivity (i.e school) and leisure activities. | Completed day 5 after treatment day 10 | |
Primary | Canadian Occupational Performance Measure (COPM) | The COPM is an individualized, family-centered tool designed to guide participants to identify self-perception of difficulties in self-care, productivity (i.e school) and leisure activities. | Completed 2 months after treatment day 10 | |
Primary | Canadian Occupational Performance Measure (COPM) | The COPM is an individualized, family-centered tool designed to guide participants to identify self-perception of difficulties in self-care, productivity (i.e school) and leisure activities. | Completed 6 months after treatment day 10 | |
Secondary | PedsQL Cerebral Palsy Module version 3.0 Young child report (ages 5-7), Child report (ages 8-12), Teen report (ages 8-12) | This instrument assesses domains of social/emotional well-being/acceptance, functioning, participation and physical health, access to services, pain and feelings about disability, and family health. The PedsQL-CP is a condition specific health related quality of life instrument validated for child self-report (5-18yrs). Version of PedsQL-CP used is age specific and will be completed by all participants. The PedsQL-CP includes scales of: daily activities, school activities, movement/balance, pain/hurt, fatigue, eating activities, and speech/communication. | Completed 2 weeks or less before treatment day 1 | |
Secondary | PedsQL Cerebral Palsy Module version 3.0 Young child report (ages 5-7), Child report (ages 8-12), Teen report (ages 8-12) | This instrument assesses domains of social/emotional well-being/acceptance, functioning, participation and physical health, access to services, pain and feelings about disability, and family health. The PedsQL-CP is a condition specific health related quality of life instrument validated for child self-report (5-18yrs). Version of PedsQL-CP used is age specific and will be completed by all participants. The PedsQL-CP includes scales of: daily activities, school activities, movement/balance, pain/hurt, fatigue, eating activities, and speech/communication. | Completed 5 days after treatment day 10 | |
Secondary | PedsQL Cerebral Palsy Module version 3.0 Young child report (ages 5-7), Child report (ages 8-12), Teen report (ages 8-12) | This instrument assesses domains of social/emotional well-being/acceptance, functioning, participation and physical health, access to services, pain and feelings about disability, and family health. The PedsQL-CP is a condition specific health related quality of life instrument validated for child self-report (5-18yrs). Version of PedsQL-CP used is age specific and will be completed by all participants. The PedsQL-CP includes scales of: daily activities, school activities, movement/balance, pain/hurt, fatigue, eating activities, and speech/communication. | Completed 2 months after treatment day 10 | |
Secondary | PedsQL Cerebral Palsy Module version 3.0 Young child report (ages 5-7), Child report (ages 8-12), Teen report (ages 8-12) | This instrument assesses domains of social/emotional well-being/acceptance, functioning, participation and physical health, access to services, pain and feelings about disability, and family health. The PedsQL-CP is a condition specific health related quality of life instrument validated for child self-report (5-18yrs). Version of PedsQL-CP used is age specific and will be completed by all participants. The PedsQL-CP includes scales of: daily activities, school activities, movement/balance, pain/hurt, fatigue, eating activities, and speech/communication. | Completed 6 months after treatment day 10 | |
Secondary | Pediatric Stroke Outcome Measure Short Neuro Exam Child Version (>2 years)(PSOM) | This is a validated outcome measure for perinatal and childhood stroke. | Completed before treatment day 1 | |
Secondary | PedsQL Cerebral Palsy Module version 3.0 Parent Report for young child(ages 5-7), Parent Report for Child(ages 8-12), Parent report for teen(ages 8-12) | This instrument assesses domains of social/emotional well-being/acceptance, functioning, participation and physical health, access to services, pain and feelings about disability, and family health from a parents perspective. The PedsQL-CP is a condition specific health related quality of life instrument validated for parent-report of their child (5-18yrs). Version of PedsQL-CP used is age specific and will be completed by all participant's parents. | Completed 2 weeks or less before treatment day 1 | |
Secondary | PedsQL Cerebral Palsy Module version 3.0 Parent Report for young child(ages 5-7), Parent Report for Child(ages 8-12), Parent report for teen(ages 8-12) | This instrument assesses domains of social/emotional well-being/acceptance, functioning, participation and physical health, access to services, pain and feelings about disability, and family health from a parents perspective. The PedsQL-CP is a condition specific health related quality of life instrument validated for parent-report of their child (5-18yrs). Version of PedsQL-CP used is age specific and will be completed by all participant's parents. | Completed day 5 after treatment day 10 | |
Secondary | PedsQL Cerebral Palsy Module version 3.0 Parent Report for young child(ages 5-7), Parent Report for Child(ages 8-12), Parent report for teen(ages 8-12) | This instrument assesses domains of social/emotional well-being/acceptance, functioning, participation and physical health, access to services, pain and feelings about disability, and family health from a parents perspective. The PedsQL-CP is a condition specific health related quality of life instrument validated for parent-report of their child (5-18yrs). Version of PedsQL-CP used is age specific and will be completed by all participant's parents. | Completed 2 months after treatment day 10 | |
Secondary | PedsQL Cerebral Palsy Module version 3.0 Parent Report for young child(ages 5-7), Parent Report for Child(ages 8-12), Parent report for teen(ages 8-12) | This instrument assesses domains of social/emotional well-being/acceptance, functioning, participation and physical health, access to services, pain and feelings about disability, and family health from a parents perspective. The PedsQL-CP is a condition specific health related quality of life instrument validated for parent-report of their child (5-18yrs). Version of PedsQL-CP used is age specific and will be completed by all participant's parents. | Completed 6 months after treatment day 10 | |
Secondary | SHUEE (Shriners Hospital Upper Extremity Evaluation) | The Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) is a video-based tool for the assessment of upper extremity function in children with hemiplegic cerebral palsy. This tool includes spontaneous functional analysis and dynamic positional analysis and assesses the ability to perform grasp and release. | Completed 2 weeks or less prior to treatment day 1 | |
Secondary | SHUEE (Shriners Hospital Upper Extremity Evaluation) | The Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) is a video-based tool for the assessment of upper extremity function in children with hemiplegic cerebral palsy. This tool includes spontaneous functional analysis and dynamic positional analysis and assesses the ability to perform grasp and release. | Completed day 5 after treatment day 10 | |
Secondary | SHUEE (Shriners Hospital Upper Extremity Evaluation) | The Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) is a video-based tool for the assessment of upper extremity function in children with hemiplegic cerebral palsy. This tool includes spontaneous functional analysis and dynamic positional analysis and assesses the ability to perform grasp and release. | Completed 2 months after treatment day 10 | |
Secondary | SHUEE (Shriners Hospital Upper Extremity Evaluation) | The Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) is a video-based tool for the assessment of upper extremity function in children with hemiplegic cerebral palsy. This tool includes spontaneous functional analysis and dynamic positional analysis and assesses the ability to perform grasp and release. | Completed 6 months after treatment day 10 | |
Secondary | Box and Blocks Test | Tests the total number of blocks moved in 60 Seconds by each participant. | Completed 2 weeks or less before treatment day 1 | |
Secondary | Box and Blocks Test | Tests the total number of blocks moved in 60 Seconds by each participant. | Completed 5 days after treatment day 10 | |
Secondary | Box and Blocks Test | Tests the total number of blocks moved in 60 Seconds by each participant. | Completed 2 months after treatment day 10 | |
Secondary | Box and Blocks Test | Tests the total number of blocks moved in 60 Seconds by each participant. | Completed 6 months after treatment day 10 | |
Secondary | TMS Tolerability Measure | This child reportable tool evaluates potential side effects or unpleasant features a child may experience after receiving TMS or Sham. Children are also asked to rate their TMS or Sham experience using a 1(most pleasant or enjoyable)- 8(most unpleasant or unenjoyable) scale. | Completed 2 weeks or less before treatment day 1 | |
Secondary | TMS Tolerability Measure | This child reportable tool evaluates potential side effects or unpleasant features a child may experience after receiving TMS or Sham. Children are also asked to rate their TMS or Sham experience using a 1(most pleasant or enjoyable)- 8(most unpleasant or unenjoyable) scale. | Completed 5days after treatment day 10 | |
Secondary | TMS Tolerability Measure | This child reportable tool evaluates potential side effects or unpleasant features a child may experience after receiving TMS or Sham. Children are also asked to rate their TMS or Sham experience using a 1(most pleasant or enjoyable)- 8(most unpleasant or unenjoyable) scale. | Completed 2 months after treatment day 10 | |
Secondary | TMS Tolerability Measure | This child reportable tool evaluates potential side effects or unpleasant features a child may experience after receiving TMS or Sham. Children are also asked to rate their TMS or Sham experience using a 1(most pleasant or enjoyable)- 8(most unpleasant or unenjoyable) scale. | Completed 6 months after treatment day 10 | |
Secondary | Grip and Pinch Strength Measures (GS, PS) | Grip and pinch strength (GS, PS) are simple, quick measures of motor power, quantifiable with hand dynamometer that have been evaluated in children with Hemiplegic Cerebral Palsy. | Completed 2 weeks or less before treatment day 1 | |
Secondary | Grip and Pinch Strength Measures (GS, PS) | Grip and pinch strength (GS, PS) are simple, quick measures of motor power, quantifiable with hand dynamometer that have been evaluated in children with Hemiplegic Cerebral Palsy. | Completed 5 days after treatment day 10 | |
Secondary | Grip and Pinch Strength Measures (GS, PS) | Grip and pinch strength (GS, PS) are simple, quick measures of motor power, quantifiable with hand dynamometer that have been evaluated in children with Hemiplegic Cerebral Palsy. | Completed 2 months after treatment day 10 | |
Secondary | Grip and Pinch Strength Measures (GS, PS) | Grip and pinch strength (GS, PS) are simple, quick measures of motor power, quantifiable with hand dynamometer that have been evaluated in children with Hemiplegic Cerebral Palsy. | Comopleted 6 months after treatment day 10 | |
Secondary | Assisting Hand Assessment (AHA) | Assisting Hand Assessment (AHA) is a sensitive, reliable, and validated assessment of bi-manual tasks (functional assistive role of the weak hand) in children with HCP. The AHA has excellent clini-metric properties for evaluating bi-manual hand activities in HCP and pCIMT trials. | Completed 2 weeks or less before treatment day 1 | |
Secondary | Assisting Hand Assessment (AHA) | Assisting Hand Assessment (AHA) is a sensitive, reliable, and validated assessment of bi-manual tasks (functional assistive role of the weak hand) in children with HCP. The AHA has excellent clini-metric properties for evaluating bi-manual hand activities in HCP and pCIMT trials. | Completed 5 days after treatment day 10 | |
Secondary | Assisting Hand Assessment (AHA) | Assisting Hand Assessment (AHA) is a sensitive, reliable, and validated assessment of bi-manual tasks (functional assistive role of the weak hand) in children with HCP. The AHA has excellent clini-metric properties for evaluating bi-manual hand activities in HCP and pCIMT trials. | Completed 2 months after treatment day 10 | |
Secondary | Assisting Hand Assessment (AHA) | Assisting Hand Assessment (AHA) is a sensitive, reliable, and validated assessment of bi-manual tasks (functional assistive role of the weak hand) in children with HCP. The AHA has excellent clini-metric properties for evaluating bi-manual hand activities in HCP and pCIMT trials. | Completed 6 months after treatment day 10 | |
Secondary | Melbourne Assessment of Unilateral Upper Limb Function (MAUULF) | A validated, criterion-referenced functional measure designed to detect therapeutic clinical change in children with HCP. Testing in children with moderate CP demonstrates high intra and inter-rater reliabilities and construct validity. We have demonstrated the utility of the MAUULF in the only previous rTMS trial in children 7-20 years with stroke-induced hemiparesis. | Completed 2 weeks or less before treatment day 1 | |
Secondary | Melbourne Assessment of Unilateral Upper Limb Function (MAUULF) | A validated, criterion-referenced functional measure designed to detect therapeutic clinical change in children with HCP. Testing in children with moderate CP demonstrates high intra and inter-rater reliabilities and construct validity. We have demonstrated the utility of the MAUULF in the only previous rTMS trial in children 7-20 years with stroke-induced hemiparesis. | Completed 5 days after treatment day 10 | |
Secondary | Melbourne Assessment of Unilateral Upper Limb Function (MAUULF) | A validated, criterion-referenced functional measure designed to detect therapeutic clinical change in children with HCP. Testing in children with moderate CP demonstrates high intra and inter-rater reliabilities and construct validity. We have demonstrated the utility of the MAUULF in the only previous rTMS trial in children 7-20 years with stroke-induced hemiparesis. | Completed 2 months after treatment day 10 | |
Secondary | Melbourne Assessment of Unilateral Upper Limb Function (MAUULF) | A validated, criterion-referenced functional measure designed to detect therapeutic clinical change in children with HCP. Testing in children with moderate CP demonstrates high intra and inter-rater reliabilities and construct validity. We have demonstrated the utility of the MAUULF in the only previous rTMS trial in children 7-20 years with stroke-induced hemiparesis. | Completed 6 months after treatment day 10 | |
Secondary | ABILHAND-Kids -Manual ability measure | Measures manual ability in children (ages 6-15) with CP as perceived by the parents. | Completed 2 weeks or less before treatment day 1 | |
Secondary | ABILHAND-Kids -Manual ability measure | Measures manual ability in children (ages 6-15) with CP as perceived by the parents. | Completed 5 days after treatment day 10 | |
Secondary | ABILHAND-Kids -Manual ability measure | Measures manual ability in children (ages 6-15) with CP as perceived by the parents. | Completed 2 months after treatment day 10 | |
Secondary | ABILHAND-Kids -Manual ability measure | Measures manual ability in children (ages 6-15) with CP as perceived by the parents. | Completed 6 months after treatment day 10 | |
Secondary | The Revised Pediatric Motor Activity Log and the Tween Motor Activity Log (PMAL / TMAL) | Motor activity questionaire which asks parents to rate how often and how well their child uses his or her affected arm to complete some everyday activities. TMAL is used for Teenagers and PMAL is used for younger children. | Completed 2 weeks or less before treatment day 1 | |
Secondary | The Revised Pediatric Motor Activity Log and the Tween Motor Activity Log (PMAL / TMAL) | Motor activity questionaire which asks parents to rate how often and how well their child uses his or her affected arm to complete some everyday activities. TMAL is used for Teenagers and PMAL is used for younger children. | Completed 5days after treatment day 10 | |
Secondary | The Revised Pediatric Motor Activity Log and the Tween Motor Activity Log (PMAL / TMAL) | Motor activity questionaire which asks parents to rate how often and how well their child uses his or her affected arm to complete some everyday activities. TMAL is used for Teenagers and PMAL is used for younger children. | Completed 2 months after treatment day 10 | |
Secondary | The Revised Pediatric Motor Activity Log and the Tween Motor Activity Log (PMAL / TMAL) | Motor activity questionaire which asks parents to rate how often and how well their child uses his or her affected arm to complete some everyday activities. TMAL is used for Teenagers and PMAL is used for younger children. | Completed 6 months after treatment day 10 | |
Secondary | Biometrics Data Sheet | Records results of 3 groups of computer calibrated games 1. Eclipse which assesses pinch strength, 2. Space Shooter which assesses hand pronation and supination and 3. Balls and buckets which assesses wrist flexion and extension. Speed level, difficulty level, Range and percentage scores are recorded. | Completed each day during the 10 day camp program | |
Secondary | Paediatric Stroke Outcome Measure Short Neuro Exam (PSOM-SNE)-Child Version (Children Aged 2yrs and Older) | This neurological assessment tool assesses a child's: Level of Consciousness, Behaviour, Mental Status, Language, Cranial Nerves, Motor Movements, Tendon Reflexes, Fine Motor Coordination, Sensory and Gait, and rates any deficits using 0 (none), 0.5 (mild), 1.0 (Moderate) to 2 (severe) scale. | Completed before treatment day 1 | |
Secondary | Home Program Log | Participants are asked to complete a home log which records which activities, Part A (Functional goal areas with 2 hands for 10 minutes)and Part B (Strengthening activities with affected hand for 5 minutes) they have completed at home on a daily basis. | Completed by each participant everyday during treatments days 1-10 | |
Secondary | Home Program Log | Participants are asked to complete a home log which records which activities, Part A (Functional goal areas with 2 hands for 10 minutes)and Part B (Strengthening activities with affected hand for 5 minutes) they have completed at home on a daily basis. | Reassessed 2 months after treatment day 10 | |
Secondary | Home Program Log | Participants are asked to complete a home log which records which activities, Part A (Functional goal areas with 2 hands for 10 minutes)and Part B (Strengthening activities with affected hand for 5 minutes) they have completed at home on a daily basis. | Reassessed 6 months after treatment day 10 | |
Secondary | Camp Evaluation Form | This evaluation tool asked participants to rate their experience in attending the PLASTIC CHAMPS camp. | Completed by participants on Day 10 of treatment |
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