Non-Invasive Brain Stimulation for Children and Young People with Cerebral Palsy

This is an exploratory pilot open label trial that will assess the safety and feasibility of active transcranial Direct Current Stimulation (tDCS) in the home setting under caregiver and remote investigator supervision, activation and monitoring. Sessions will be supervised by a paediatric neurologist with a minimum of 10 years' experience, tDCS stimulates the brain by using low levels of electricity to affect the activity and connections between brain cells. The electricity is applied using sponges placed at specific locations on the scalp. Participation will occur over five days for one hour each day. Active stimulation sessions will be 20 minutes in duration, at a current intensity of 1.5 mA. Individual participant tolerance will be assessed prior to stimulation sessions, and current intensity adjusted as necessary. The tDCS device used in the study is the Soterix Medical 1x1 Transcranial Direct Current Stimulator Mini - Clinical Trials (CT), model 1601. Accessories used will include head straps with disposable sponge pads; measuring tape, alcohol swabs, skin pencils and a Box and Blocks Test kit. Caregiver training will be provided in the first intervention session by the supervising remote investigator. Caregivers will be shown two instructional videos, one to perform head measurements to select the correct sized headgear, and another to demonstrate tDCS device set up. The caregiver will then be stepped through both processes in real time by the supervising remote investigator. This process is estimated to take approximately 30 minutes. The caregiver will be asked to take a photograph of the device set up using their phone and upload this to REDCap for review by the study team. The intervention session will not progress until the set up has been reviewed by the study team and deemed to be correct. At the beginning of every stimulation session thereafter, the caregiver will be stepped through the process of device set up in real time, and correct set up will again be reviewed by the study team following the process above. This process is estimated to take approximately 10 minutes. This process will always occur before proceeding with the stimulation. Adherence to the trial protocol will be monitored during the real-time set up process and via device analytics.