Stimulation for Perinatal Stroke Optimizing Recovery Trajectories

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

89

Participants

Timeline

Start Date

July 21, 2017

Primary Completion Date

March 18, 2023

Study Completion Date

March 18, 2023

Conditions
Perinatal StrokeHemiplegic Cerebral Palsy
Interventions
DEVICE

Cathodal transcranial direct current stimulation

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.

DEVICE

Sham transcranial direct current stimulation

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.

Trial Locations (1)

T2M 1N4

University of Calgary, Calgary

All Listed Sponsors
collaborator

University of Alberta

OTHER

collaborator

Holland Bloorview Kids Rehabilitation Hospital

OTHER

collaborator

The Hospital for Sick Children

OTHER

lead

University of Calgary

OTHER

NCT03216837 - Stimulation for Perinatal Stroke Optimizing Recovery Trajectories | Biotech Hunter | Biotech Hunter