NCT03216837: SPORT

Stimulation for Perinatal Stroke Optimizing Recovery Trajectories

Completed Phase 2, PHASE3 Last updated 28 March 2024

What this trial tests

Phase 2, PHASE3 trial testing Cathodal transcranial direct current stimulation in Perinatal Stroke in 89 participants. Completed in 18 March 2023.

Timeline

21 July 2017

Primary endpoint
18 March 2023

18 March 2023

Quick facts

Lead sponsor	University of Calgary
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	89
Start date	21 July 2017
Primary completion	18 March 2023
Estimated completion	18 March 2023
Sites	1 location across Canada

Drugs / interventions tested

• Cathodal transcranial direct current stimulation
• Sham transcranial direct current stimulation

Conditions studied

• Perinatal Stroke — all drugs for Perinatal Stroke →
• Hemiplegic Cerebral Palsy — all drugs for Hemiplegic Cerebral Palsy →

Sponsor

University of Calgary

Who can join

Adults 6 to 18, any sex, with Perinatal Stroke or Hemiplegic Cerebral Palsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neuromodulation for Children With Hemiparesis and Perinatal Stroke: A Randomized Clinical Trial.
   Hilderley AJ, Dunbar M, Andersen J, Fehlings D, et al · · 2025 · cited 8× · PMID 39899326 · DOI 10.1001/jamaneurol.2024.4898
2. Protocol for a cost-utility analysis of neurostimulation and intensive camp-based therapy for children with perinatal stroke and hemiparesis based on a multicentre clinical trial.
   Berrigan P, Hodge J, Kirton A, Moretti ME, et al · · 2021 · cited 4× · PMID 33468454 · DOI 10.1136/bmjopen-2020-041444
3. Bilateral actigraphic quantification of upper extremity movement in hemiparetic children with perinatal stroke: a case control study.
   Hollis A, Cole L, Zewdie E, Metzler MJ, et al · · 2021 · cited 3× · PMID 34915898 · DOI 10.1186/s12984-021-00962-9
4. Robotic mapping of motor cortex in children with perinatal stroke and hemiparesis.
   Kuo HC, Zewdie E, Giuffre A, Gan LS, et al · · 2022 · cited 1× · PMID 35451540 · DOI 10.1002/hbm.25881
5. Thalamic oscillatory dysrhythmia and disrupted functional connectivity in thalamocortical loops in perinatal stroke.
   Rogachov A, Carlson HL, Robertson A, Domi T, et al · · 2025 · PMID 40216875 · DOI 10.1038/s41598-025-95560-3