MIT Injection Study
Randomized, Crossover Study in Healthy Volunters for the Assessment of Subcutaneous Injection Tolerance with Automatic Pain Recognition
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 50 participants
Intervention/treatment: Subcutaneous injection of a viscous placebo buffer.
Study description: Many drugs, such as monoclonal antibodies, are administrated using parenteral delivery devices via subcutaneous injections. Unfortunately, needle phobia, anxiety before and during needle insertion and pain during injections are key aspects that lead to poor therapeutic compliance and prevent wider applicability and acceptance of this technology across patient groups. Therefore, in order to improve patient experience, traditional pain scores using a visual analog scale (VAS) or other similar techniques have been used to compare and investigate different subcutaneous injection methodologies. However, they are subjective and it is difficult to power a clinical study to show significant differences in pain.
In this study, we propose to use electrodermal activity (EDA), heart rate variability (HRV), and facial expression analysis as potential endpoints to determine quantitative pain scores during the injection process, together with other secondary endpoints such as wellness aspects of patients (e.g. sleep quality). Therefore, the objective of this study is to evaluate these endpoints in subcutaneous injections for different injection methodologies (consisting of different dose volumes, flow rates, needle gauges and injectate viscosity) in a clinical setting in humans. The data will be used to understand pain upon injection and see if there is any correlation between traditional pain scores (e.g. visual analog scale) and our proposed endpoints.
Injection Study Setup