Ignite Creation Date:
2024-05-05 @ 10:46 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01189058
Status:
UNKNOWN
Last Update Posted:
2013-10-23
First Post:
2010-08-20
Brief Title:
Modulation of Brain Plasticity After Perinatal Stroke
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Modulation of Brain Plasticity After Perinatal Stroke The PLASTIC CHAMPS Trial
Status:
UNKNOWN
Status Verified Date:
2013-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLASTIC CHAMPS
Brief Summary:
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 Childrens Hospital Application is currently underway to expand recruitment to Northern Alberta through the Glenrose Rehabilitation Hospital and Stollery Childrens Hospital to enable patients from Northern Alberta greater opportunity to participate as subjects in this study
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 Childrens Hospital Application is currently underway to expand recruitment to Northern Alberta through the Glenrose Rehabilitation Hospital and Stollery Childrens Hospital to enable patients from Northern Alberta greater opportunity to participate as subjects in this study
Detailed Description:
Perinatal stroke is the leading cause of the most common term-born cerebral palsy hemiplegic CP HCP With morbidity spanning all aspects of a childs life and lasting for decades global impact is large Mechanisms are poorly understood and prevention strategies remain elusive Treatments are limited leading to loss of hope in children and families that merits exploration of new interventions Constraint-induced movement therapy CIMT may benefit but proper clinical trials are required The investigators clinical-radiographic classifications have established perinatal stroke syndromes correlating with neurological outcome Most common are 1 arterial ischemic stroke of the middle cerebral artery AIS-MCA featuring cortical and subcortical damage acquired at birth and 2 periventricular venous infarction PVI a novel subcortical injury acquired in utero These syndromes differ in the essential variables for plastic organization after perinatal injury location and timing In addition recent animal and human studies suggest they may share a similar maladaptive plasticity whereby motor control of the weak side is installed in the non-lesioned hemisphere during development Despite the ideal plasticity model such focal injury in a young brain provides studies have been limited and suffer from small numbers of older patients with heterogeneous lesions The value of studying plastic organization will be realized upon translation into meaningful patient benefits
Transcranial magnetic stimulation TMS offers non-invasive measurement of the neurophysiological brain properties underlying neuroplasticity Repetitive TMS rTMS may modulate such systems with therapeutic effect the investigators recently demonstrated the ability of rTMS to improve motor function in children with chronic stroke Advances in perinatal brain injury and neurodevelopment are for the first time affording novel windows of opportunity for interventions to direct plastic organization toward better outcomes Via the Alberta Perinatal Stroke Project APSP the investigators propose a clinical trial of two interventions to improve function in HCP while measuring the fundamental neurophysiological properties at play
Aim 1 Determine if rTMS and CIMT can improve motor function in HCP Hypothesis Two weeks of daily rTMS improves motor function at 30 days
Aim 2 Define the neurophysiology of motor organization in stroke-induced HCP at baseline and following rTMS and CIMT
Hypothesis rTMS and CIMT reduce excitability of the non-lesioned motor cortex
Population-based studies through the Alberta Perinatal Stroke Project APSP are establishing the largest perinatal stroke cohort to date The investigators will complete a factorial 2 x 2 randomized clinical trial to determine the ability of daily rTMS and CIMT to improve motor function in children with HCP Families will attend a child-centered custom-designed intensive motor learning rehabilitation program KidsCan Power Camp for 2 weeks Outcomes include validated measures of motor function and CP quality of life The investigators will simultaneously measure the neurophysiology of plastic organization using TMS including cortical excitability interhemispheric inhibition and short interval intracortical inhibition Baseline measures will define organization patterns while post-interventional measurement will evaluate the neurophysiological effects of rTMS and CIMT Four groups of 16 children each n64 will be studied over 24 months with interim safety analysis after 10 and 32 patients
Successful completion is assured by principle investigator experience in perinatal stroke and TMS and the collaborative support of world leaders in pediatric and adult stroke TMS basic neuroscience and physiatryrehabilitation Understanding perinatal stroke plasticity and discovering methods to modulate it toward better outcomes carries a large impact greatest for children with CP and their families
Transcranial magnetic stimulation TMS offers non-invasive measurement of the neurophysiological brain properties underlying neuroplasticity Repetitive TMS rTMS may modulate such systems with therapeutic effect the investigators recently demonstrated the ability of rTMS to improve motor function in children with chronic stroke Advances in perinatal brain injury and neurodevelopment are for the first time affording novel windows of opportunity for interventions to direct plastic organization toward better outcomes Via the Alberta Perinatal Stroke Project APSP the investigators propose a clinical trial of two interventions to improve function in HCP while measuring the fundamental neurophysiological properties at play
Aim 1 Determine if rTMS and CIMT can improve motor function in HCP Hypothesis Two weeks of daily rTMS improves motor function at 30 days
Aim 2 Define the neurophysiology of motor organization in stroke-induced HCP at baseline and following rTMS and CIMT
Hypothesis rTMS and CIMT reduce excitability of the non-lesioned motor cortex
Population-based studies through the Alberta Perinatal Stroke Project APSP are establishing the largest perinatal stroke cohort to date The investigators will complete a factorial 2 x 2 randomized clinical trial to determine the ability of daily rTMS and CIMT to improve motor function in children with HCP Families will attend a child-centered custom-designed intensive motor learning rehabilitation program KidsCan Power Camp for 2 weeks Outcomes include validated measures of motor function and CP quality of life The investigators will simultaneously measure the neurophysiology of plastic organization using TMS including cortical excitability interhemispheric inhibition and short interval intracortical inhibition Baseline measures will define organization patterns while post-interventional measurement will evaluate the neurophysiological effects of rTMS and CIMT Four groups of 16 children each n64 will be studied over 24 months with interim safety analysis after 10 and 32 patients
Successful completion is assured by principle investigator experience in perinatal stroke and TMS and the collaborative support of world leaders in pediatric and adult stroke TMS basic neuroscience and physiatryrehabilitation Understanding perinatal stroke plasticity and discovering methods to modulate it toward better outcomes carries a large impact greatest for children with CP and their families
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None