Background: Children diagnosed with cerebral palsy (CP) often experience various limitations, particularly in gross motor function and activities of daily living. Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that has been used to improve movement, gross motor function, and activities of daily living.
Objective: This study aims to evaluate the potential additional effects of physiotherapy combined with tDCS in children with CP in comparison with physiotherapy only.
Methods: This is a 2-arm randomized controlled trial that will compare the effects of tDCS as an adjunctive treatment during rehabilitation sessions to rehabilitation without tDCS. Children with CP classified by the Gross Motor Function Classification System as levels I and II will be randomly assigned to either the sham + rehabilitation group or the tDCS + rehabilitation group. The primary outcome will be the motor skills assessed using the Gross Motor Function Measure domain E scores, and the secondary outcome will be the measurement scores of the children's quality of life. The intervention will consist of a 10-day stimulation protocol with tDCS spread over 2 weeks, with stimulation or sham tDCS administered for 20 minutes at a frequency of 1 Hz, in combination with physiotherapy. Physical therapy exercises will be conducted in a circuit based on each child's baseline Gross Motor Function Measure results. The participants' changes will be evaluated and compared in both groups. Intervenient features will be tested.
Results: Data collection is ongoing and is expected to be completed by January 2025. A homogeneous sample and clear outcomes may be a highlight of this protocol, which may allow us to understand the potential use of tDCS and for whom it should or should not be used.
Conclusions: A study with good evidence and clear outcomes in children with CP might open an avenue for the potential best use of neurostimulation.
Trial registration: Brazilian Registry of Clinical Trials RBR-104h4s4y; https://tinyurl.com/47r3x2e4.
International registered report identifier (irrid): PRR1-10.2196/52922.
Keywords: RCT; brain stimulation; cerebral palsy; child; children; clinical trial; development; gait; injuries; injury; motor; neurological injuries; patient; patients; physical therapy; quality of life; randomized; randomized clinical trial; researcher; researchers; stimulation; tDCS; transcranial direct current stimulation.
©Anna Izabel Cangussu, Beatriz Lucarini, Igor de Freitas Melo, Paula Araújo Diniz, Marisa Mancini, Bernardo de Mattos Viana, Marco Aurélio Romano-Silva, Débora Marques de Miranda. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 30.04.2024.