Status:
UNKNOWN
Modulation of Brain Plasticity After Perinatal Stroke
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Heart and Stroke Foundation of Canada
University of Alberta
Conditions:
Stroke
Cerebral Palsy
Eligibility:
All Genders
6-18 years
Phase:
PHASE2
PHASE3
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 traditionall...
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 child's life and lasting for decades, global impact is ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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).
- MRI confirmed AIS-MCA or PVI (neuroradiological syndrome classified by two blinded, experienced investigators according to previously validated methods)
- Age at enrollment: 6-18 years
- Resident in province of Alberta for period of study
- Informed consent/assent
- Exclusion criteria:
- Multifocal perinatal stroke or other brain injury/abnormality
- Severe hemiparesis (no voluntary contraction in paretic hand, MACS level V)
- Intellectual disability causing an inability to comply with study protocol
- Unstable epilepsy (\>1 seizure/month or \>2 medication changes (dose or agent) in the last 6 months or history of recurrent status epilepticus)
- Any TMS contraindication including implanted electronic devices
- Botulinum toxin A injection in the affected upper extremity within the preceding 6 months
- Orthopedic surgery in the affected upper extremity in the previous 12 months
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2014
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01189058
Start Date
August 1 2010
End Date
March 1 2014
Last Update
October 23 2013
Active Locations (1)
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1
Alberta Childrens Hospital
Calgary, Alberta, Canada, T3B 6A8