Please select the arm or intervention descriptions that belong 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: Intervention Type: BEHAVIORAL; Name: Pediatric Constraint-Induced Movement therapy; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Conventional pediatric motor rehabilitation therapy; Assigned to Arm(s): N/A
B: Arm Label: Treatment dosage levels examined; Type: EXPERIMENTAL; Interventions: Other: Therapy services (ACQUIREc Therapy) | Intervention Type: OTHER; Name: Therapy services (ACQUIREc Therapy); Assigned to Arm(s): Treatment dosage levels examined
C: Arm Label: rTMS and CIMT; Type: EXPERIMENTAL; Interventions: Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS), Procedure: Constraint-induced movement therapy (CIMT) | Arm Label: rTMS and no CIMT; Type: EXPERIMENTAL; Interventions: Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS) | Arm Label: Sham and CIMT; Type: EXPERIMENTAL; Interventions: Procedure: Constraint-induced movement therapy (CIMT) | Arm Label: Sham and no CIMT; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: Repetitive Transcranial Magnetic Stimulation (rTMS); Assigned to Arm(s): rTMS and CIMT, rTMS and no CIMT | Intervention Type: PROCEDURE; Name: Constraint-induced movement therapy (CIMT); Assigned to Arm(s): Sham and CIMT, rTMS and CIMT
D: Arm Label: Constraint-induced Movement Therapy; Type: EXPERIMENTAL; Interventions: Behavioral: Modified Constraint-induced Movement Therapy | Arm Label: Transditional rehabilitation; Type: OTHER; Interventions: Behavioral: Modified Constraint-induced Movement Therapy | Intervention Type: BEHAVIORAL; Name: Modified Constraint-induced Movement Therapy; Assigned to Arm(s): Constraint-induced Movement Therapy, Transditional rehabilitation

Answer: C