Smartphone app for quantification and estimation of hyperkinesia

Purpose and goal:

The project aims to develop a prototype for a mobile app for the objective quantification of hyperkinesia and validate the new functionality in a clinical setting when individualizing neurological treatments in two hospitals. Hyperkinesia is characterized by involuntary jerky movements and often occurs as a side effect in the treatment of e.g. Parkinson´s disease (PS). It is common for patients themselves to have difficulty identifying or grading dyskinesia.

Expected results and effects:

We can objectively quantify and classify hyperkinesia. No obvious risks has been noticed with the investigational device. The process of commercialisation, where certification at FDA is the next step, has been started and a pre-sub meeting been held about the regulatory pathway. The process of CE-certification is performed after FDA clearance (510(k)). The method is fast, simple and non-invasive.

Approach and implementation:

The amount of work needed to apply for and starting clinical trial was significantly more than expected with the new regulatory framework MDR. The product has been developed, patients have been recruited, patient visits have been conducted, study protocols have been completed, statistical analysis has begun with initial results. We decided to conduct an examination at an own patient visit, as protocols, informed consent and execution of assessment tasks would have taken too much time from a normal patient visit.