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Neuromodulation Therapy

Cathodal Transcranial direct current stimulation for Perinatal Stroke (SPORT Trial)

Phase 2 & 3
Waitlist Available
Led By Adam Kirton, MD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.baseline, within one month prior to the start of intervention. 2. 1 week post intervention. 3. 6 months post intervention
Awards & highlights

Summary

Perinatal stroke causes lifelong neurological disability and most hemiparetic cerebral palsy (CP). With morbidity spanning diverse aspects of a child's life and lasting for decades, global impact is large, including 10000 Canadian children. With pathophysiology poorly understood and prevention strategies non-existent, the burden of hemiparetic CP will persist. Limited treatments lead to loss of hope for children and families, necessitating exploration of new therapies. The investigators have evidence that the investigators have a durable new treatment for perinatal stroke, combining non-invasive neurostimulation and child-centred intensive rehabilitation. Via the CHILD-BRIGHT SPOR national network, the investigators will execute a multicentre trial to prove this treatment can improve function in children with perinatal stroke and hemiparetic CP. Using novel advanced technologies not available elsewhere in the world, the investigators will explore how developmental plasticity determines function and response to neuromodulation therapy. This patient oriented effort will advance personalized, precision medicine in pediatric neurorehabilitation to improve outcomes for disabled children and their families.

Eligible Conditions
  • Perinatal Stroke
  • Cerebral Palsy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.baseline, within one month prior to the start of intervention. 2. 1 week post intervention. 3. 2 months post intervention. 4. 6 months post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.baseline, within one month prior to the start of intervention. 2. 1 week post intervention. 3. 2 months post intervention. 4. 6 months post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in Assisting Hand Assessment (AHA) at 1 week, 2 month and 6 month post intervention.
Change from baseline in Canadian Occupational Performance Measure (COPM) at 1 week, 2 month and 6 month post intervention.
Secondary outcome measures
Interventional procedure
Change from baseline in Jebsen Taylor Test of Hand Function (JTTHF) at 1 week, 2 month and 6 month post intervention.
Change from baseline in Mirror Movements at 1 week, 2 month and 6 month post intervention.
+4 more
Other outcome measures
Interventional procedure
Change from baseline in Loneliness and Dissatisfaction from 1 week, 2 month and 6 months post intervention.
Change from baseline using the Box and blocks each day of the trial
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cathodal Transcranial direct current stimulationExperimental Treatment1 Intervention
Cathodal tDCS
Group II: Sham Transcranial direct current stimulationPlacebo Group1 Intervention
Sham
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cathodal transcranial direct current stimulation
2017
Completed Phase 3
~150

Find a Location

Who is running the clinical trial?

University of AlbertaOTHER
913 Previous Clinical Trials
390,630 Total Patients Enrolled
2 Trials studying Perinatal Stroke
51 Patients Enrolled for Perinatal Stroke
Holland Bloorview Kids Rehabilitation HospitalOTHER
67 Previous Clinical Trials
13,978 Total Patients Enrolled
The Hospital for Sick ChildrenOTHER
704 Previous Clinical Trials
6,956,840 Total Patients Enrolled
1 Trials studying Perinatal Stroke
80 Patients Enrolled for Perinatal Stroke
~11 spots leftby Sep 2025