Modulation of Brain Plasticity After Perinatal Stroke

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.

Conditions

• Stroke
• Cerebral Palsy

Interventions

PROCEDURE

Repetitive Transcranial Magnetic Stimulation (rTMS)

TMS can affect discrete functional ares of motor cortex offering non-invasive, painless mapping and modulation of motor systems. Inhibitory rTMS (1Hz)has been shown to safely lower motor cortex excitability in normal patients as well as adult and pediatric stroke patients. Dose is 20 minutes per day (1200 stimulations) x 10 days administered over the non-lesioned M1.

PROCEDURE

Constraint-induced movement therapy (CIMT)

CIMT uses gentle restraint of the fully functional upper extremity to promote functional gains in the affected upper extremity. CIMT is well established to be safe and is likely effective in children with hemiplegic cerebral palsy, many of whom have perinatal stroke as studied here. A custom-fitted, bivalved cast is applied and worn for \>90% of waking hours for the 2 weeks of active treatment according to protocol with daily assessments for comfort.

Sponsors & Collaborators

• Heart and Stroke Foundation of Canada

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• University of Calgary

  lead OTHER

Principal Investigators

• Adam Kirton, MD MSc FRCPC · University of Calgary

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

6 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2014-02-28

Completion

2014-03-31

Countries

• Canada

Study Locations