Please select the eligibility criteria that correspond to the clinical trial below.
Title: Modulation of Brain Plasticity After Perinatal Stroke: The PLASTIC CHAMPS Trial
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 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.


Options:
A: Inclusion Criteria

* Clinical diagnosis of hemiparetic cerebral palsy consistent with criteria in Swaiman and Russman (1999) and Badawi et al. (1998)
* Recommended for participation in pediatric rehabilitation and/or early intervention
* Lives within 50 miles of the Civitan Center at University of Alabama at Birmingham or the family is willing to temporarily relocate to the Birmingham area for treatment

Exclusion Criteria

* Profound bilateral hearing loss with the use of hearing aids
* Severe visual impairment
* Serious seizure disorder or uncontrolled seizures
* Genetic and syndromic conditions historically excluded for CP registries
* Familial Spastic Paraplegia
* Ataxic Cerebral Palsy
* Diagnosis of Pervasive Developmental Disability or autism
* Serious or recurring medical complications
* Scheduled for surgery within 12 months of study entry
B: Inclusion Criteria:

* Children 3-6 years of age
* Hemiparetic CP

Exclusion Criteria:

* No prior CI therapy treatments
* No Botox for 6-months
C: 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
D: Inclusion Criteria:

1. Development learned-nonuse
2. Age range 4y/o-15y/o
3. Wrist ext 10˚, MP j't ext 10˚ in affected U/E
4. Can fallow up the simple instruction
5. Modified Ashworth Scale ≦2
6. Pediatric Motor Activity Log ≦2.5 (average)

Exclusion Criteria:

1. Related muscle skeleton surgery
2. Selective dorsal rhizotomy
3. Botulinum toxin in 6 months
4. Visual perception impaired
5. Hearing perception impaired
6. Balance ability impaired (in constrained)

Answer: C