TOlerabililty of Transcranial Direct Current Stimulation in Pediatric Stroke Survivors 2 (TOPSS 2)

Overview

The TOPSS 2 study evaluates the safety, tolerability, and potential benefit of transcranial direct current stimulation (tDCS)—a non-invasive form of electrical brain stimulation—paired with intensive arm rehabilitation therapy in children and adolescents with chronic weakness after childhood-onset stroke. tDCS may help motor recovery by promoting neuroplasticity. This study aims to determine whether tDCS can safely be used in children, improve upper-extremity motor function, and inform design of future clinical trials.

Participants are randomized to receive either active or sham (placebo) tDCS during a two-week rehabilitation period. After completing the blinded phase and follow-up, participants who initially received sham stimulation are invited to return for an open-label extension to receive active tDCS.

Population of the study: Children and adolescents aged 5 to 19 years with hemiparesis (arm weakness) following arterial ischemic or hemorrhagic childhood-onset stroke (≥3 months after the stroke event).
Intervention:

• Active tDCS: Bihemispheric stimulation using a 2 mA current applied via saline-soaked scalp electrodes for 20 minutes, immediately followed by 2 hours of one-on-one occupational therapy targeting the weaker arm.
• 10 total sessions over a 2-week period.
• tDCS parameters are individualized for comfort and safety, with continuous monitoring of vitals and tolerability.

Control: Participants randomized to sham stimulation receive identical therapy sessions with inactive current. All participants receive standard rehabilitation therapy under therapist supervision.
After 6-month follow-up, sham participants are offered open-label active tDCS using the same two-week therapy protocol.

Outcomes:

Primary (tolerability):

• Percentage of participants completing all stimulation sessions
• Percentage reporting only mild side effects (tingling, itching, or transient discomfort)
• Changes in vital signs (pulse and blood pressure) before and after stimulation

Secondary (exploratory efficacy:

• Change in Fugl-Meyer Upper Extremity (FM-UE) score from baseline to 6 months
• Secondary measures: Canadian Occupational Performance Measure (COPM), Box and Blocks Test, Pediatric Stroke Outcome Measure (PSOM), Melbourne Assessment of the Upper Extremity, and NIH Toolbox cognitive tests
• MRI-based measures of corticospinal connectivity (fractional anisotropy) and electric field modeling to explore predictors of response.

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Trial Information

Target Enrollment: 20 participants
Funder: National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS) — Child Neurologist Career Development Program (CNCDP K12)
Duration of Study: 3 years total (participant involvement up to 6 months; open-label extension available after follow-up)

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Principal Investigator

Stuart Fraser, MD

Links & Resources

TOPSS (1) abstract

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