Stimulation for Perinatal Stroke Optimizing Recovery Trajectories

NCT03216837 | Completed DMC

• 1 other identifier: REB16-2535
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Perinatal Stroke; Hemiplegic Cerebral Palsy

Keywords

Perinatal stroke; hemiplegia; hemiplegic cerebral palsy

Outcome Measures

Primary Outcomes (2)

• Change from baseline in Assisting Hand Assessment (AHA) at 1 week, 2 month and 6 month post intervention.

  This is the established standard for the objective quantification of bilateral hand function in children with hemiparetic CP141. This Rasch-built evaluation carries the strongest evidence of inter-rater, intra-rater, and test-retest reliabilities, test-validity, and responsiveness to change for bimanual tasks in hemiparetic CP children 8 within our age range. Sensitivity to change and excellent clinimetric properties have been established in multiple pediatric hemiparetic CP clinical trials. Our trained therapists have successfully executed \>100 AHA measurements in our current trial124 with no limitations and robust data.

  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

• Change from baseline in Canadian Occupational Performance Measure (COPM) at 1 week, 2 month and 6 month post intervention.

  Individualized, family-centered tool identifying child and family-perceived difficulties in self-care, productivity (school), and activities142. Such subjective measures are essential in hemiparetic CP trials. Validated for our ages and such trials, the COPM was a robust measure in our previous perinatal stroke trials (Figure 4). We have recently characterized how COPM goals are set in this population and their relationship to success (Haspels et al, unpublished).

  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

Secondary Outcomes (7)

• Change from baseline in Children's Hand-use Experience Questionnaire (CHEQ) at 1 week, 2 month, and 6 month post intervention.

  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

• Change from baseline in Mirror Movements at 1 week, 2 month and 6 month post intervention.

  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

• Change from baseline in Jebsen Taylor Test of Hand Function (JTTHF) at 1 week, 2 month and 6 month post intervention.

  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

• Change from baseline using the Box and blocks at 1 week, 2 month and 6 month post intervention.

  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

• Change from baseline in the Quality of Life (QoL) assessment at 1 week, 2 month and 6 month post intervention.

  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

Other Outcomes (8)

• Change from baseline using the Box and blocks each day of the trial

  Baseline, day 1, day 2, day3 , day 4, day5, day 6, day 7, day 8, day 9, day 10.

• Pre and post intervention Advanced Neuroimaging

  Baseline, 1 week and 6 months post intervention.

• Pre and post intervention robotic motor mapping

  Baseline, 1 week and 6 months post intervention.

Study Arms (2)

Cathodal Transcranial direct current stimulation

EXPERIMENTAL

Cathodal tDCS

Device: Cathodal transcranial direct current stimulation

Sham Transcranial direct current stimulation

SHAM COMPARATOR

Sham

Device: Sham transcranial direct current stimulation

Interventions

Cathodal transcranial direct current stimulation DEVICE

The primary intervention will be cathodal (inhibitory) tDCS over the contralesional M1. Soft, replaceable 25cm2 electrodes (Soterix, NYC) will be placed on clean, dry areas of the scalp. The cathode will be placed over the contralesional M1, precisely mapped for each patient using neuronavigated (Brainsight2, Rogue Research, Montreal QU) MRI-TMS co-registration over the hotspot for the contralateral first dorsal interosseous muscle. The current-controlled model stimulator (Soterix, NYC) will automatically ramp up slowly over 30 seconds to the treatment current of 1.0 milliamp. tDCS will be administered each day during the first 30 minutes of the daily 1:1 therapy sessions.

Also known as: tDCS

Cathodal Transcranial direct current stimulation

Sham transcranial direct current stimulation DEVICE

Soft, replaceable 25cm2 electrodes (Soterix, NYC) will be placed on clean, dry areas of the scalp. The cathode will be placed over the contralesional M1, precisely mapped for each patient using neuronavigated (Brainsight2, Rogue Research, Montreal QU) MRI-TMS co-registration over the hotspot for the contralateral first dorsal interosseous muscle.The current-controlled model stimulator (Soterix, NYC) will automatically ramp up slowly over 30 seconds to the treatment current of 1.0 milliamp and then ramp down over 30 seconds to 0 milliamps. Sham will be administered each day during the first 30 minutes of the daily 1:1 therapy sessions.

Also known as: Sham

Sham Transcranial direct current stimulation

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinical and MRI confirmed perinatal ischemic stroke (NAIS, APPIS, PVI)
• Symptomatic hemiparetic CP including parent/child perceived limitations in function
• Able to briefly lift light object off a surface (estimated House class 3-6).
• Informed child consent/assent and parental/guardian consent

You may not qualify if:

• Other neurological disorder not related to perinatal stroke
• Multifocal stroke
• Severe hemiparesis (no voluntary contraction, MACS V)
• Sever spasticity (Modified Ashworth Scale \>3)
• Severe delay or inability to comply with protocol
• Unstable epilepsy
• TMS or MRI contraindication
• Orthopedic surgery, constraint, brain stimulation or other modulatory therapy in past 6 months prior to camp day 1
• Botulinum toxin injections in past 4 months prior to camp day 1

Sponsors & Collaborators

• University of Calgary: lead
• University of Alberta: collaborator
• Holland Bloorview Kids Rehabilitation Hospital: collaborator
• The Hospital for Sick Children: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2M 1N4, Canada

Location

Related Publications (2)

• Hilderley AJ, Dunbar M, Andersen J, Fehlings D, Metzler M, Carlson HL, Zewdie E, Hodge J, O'Grady K, Carsolio L, Dlamini N, Giuffre A, Cole L, Kuo HC, Bourgeois A, Hollis A, Maiani M, Ciechanski P, Jadavji Z, Craig B, Kelly D, Keough J, Wrightson J, Fay L, Switzer L, Pajevic M, Ramsey A, Sametz M, Brooks BL, Yaskina M, Batara J, Hill MD, Kirton A. Neuromodulation for Children With Hemiparesis and Perinatal Stroke: A Randomized Clinical Trial. JAMA Neurol. 2025 Mar 1;82(3):267-275. doi: 10.1001/jamaneurol.2024.4898.

  PMID: 39899326 DERIVED

• Berrigan P, Hodge J, Kirton A, Moretti ME, Ungar WJ, Zwicker JD. 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. BMJ Open. 2021 Jan 19;11(1):e041444. doi: 10.1136/bmjopen-2020-041444.

  PMID: 33468454 DERIVED

MeSH Terms

Conditions

Hemiplegia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Adam Kirton, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: July 13, 2017
• Study Start: July 21, 2017
• Primary Completion: March 18, 2023
• Study Completion: March 18, 2023
• Last Updated: May 5, 2026

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)