Co-Creation of a Study Protocol to Assess the Effect of Transcranial Direct Current Stimulation in the Management of Fatigue in Children and Young People With Acquired Brain Injury (Fatiguebrain-tDCS).

backgroundChildren and young people (CYP) with moderate/severe acquired brain injury (ABI) often have problems with chronic cognitive fatigue. Methylphenidate, a controlled drug, and cognitive behavioural therapy have been used to manage fatigue, but their effects are not fully established, and they are not widely available. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that has shown promise for managing fatigue in adults with neurological conditions. However, no studies have used tDCS to manage fatigue in CYP with ABI nor have involved patients to co-create the intervention or research protocol.

objectiveTo co-create a trial protocol for a study examining the feasibility of using tDCS as an intervention to manage fatigue in CYP with ABI and provide proof-of-concept for its efficacy through patient public involvement and engagement (PPIE).

designOur co-creation approach encompassed three key stages: co-define, co-design, and co-refine to actively bring stakeholders together. The co-define phase consisted of discussing end-users' experiences and needs related to fatigue. We then co-designed an intervention protocol to address fatigue using tDCS. The final phase invited stakeholder feedback to co-refine the tDCS intervention, ensuring it was acceptable and sustainable. SETTING AND

participantsStakeholders (n = 42) included CYP with ABI and their parents as well as members of an established young persons' advisory group. Stakeholders participated in in-person, online and hybrid focus groups, 1:1 meetings, and surveys, over five stages.

resultsWe followed the Medical Research Council guidelines for intervention development and used design thinking approaches to co-create the tDCS intervention. This process led to the development of a study protocol where tDCS is delivered at home rather than in the hospital and to monitor sessions remotely via an online platform. The treatment duration was extended to 4 weeks to maximise the likelihood of detecting beneficial effects. Stakeholder contribution also led to the inclusion of children with neurodiversity and to making the research more accessible for everyone. DISCUSSION AND

conclusionsPPIE members were involved in co-defining the problem, co-designing the intervention, determining treatment parameters, selecting efficacy outcome measures, identifying barriers to adherence, developing mitigating strategies, and co-producing and reviewing the research study protocol. This ongoing stakeholder involvement shaped the co-creation process, balancing idealistic approaches with feasible steps. Our protocol considered implementation barriers from the start and balanced scientific needs with patient and family priorities. The PPIE members will continue to be involved in conducting the study and designing qualitative work, reinforcing their ongoing engagement. PATIENT OR PUBLIC CONTRIBUTION: To develop this study protocol, the PPIE members were actively involved in defining the problem, creating the intervention, determining treatment parameters, selecting the relevant outcome measures, identifying barriers to adherence, developing mitigating strategies, reviewing the research study protocol and writing the manuscript.