Study protocol for a randomised pilot study of a computer-based, non-pharmacological cognitive intervention for motor...

Parkinson's disease (PD) is a chronic, neurodegenerative disorder affecting over 137,000 people in the UK and an estimated five million people worldwide. Treatment typically involves long-term dopaminergic therapy, which improves motor symptoms, but is associated with dose-limiting side effects. Developing effective complementary, non-pharmacological interventions is of considerable importance. This paper presents the protocol for a three-arm pilot study to test the implementation of computer-based cognitive training that aims to produce improvements or maintenance of motor slower and motor fatigue symptoms in people with PD. The primary objective is to assess recruitment success and usability of external data capture devices during the intervention. The secondary objectives are to obtain estimates of variance and effect size for changes in primary and secondary outcome measures to inform sample size calculations and study design for a larger scale trial.

The study aims to recruit between 40 and 60 adults with early- to middle-stage PD (Hoehn and Yahr 1-3) from National Health Service (NHS) outpatients' clinics and support groups across North Wales, UK. Participants will be randomised to receive training over five sessions in either a spatial grid navigation task, a sequential subtraction task or a spatial memory task. Patient-centred outcome measures will include motor examination scores from part 3 of the UPDRS-III and data from movement kinematic and finger tapping tasks.

The results of this study will provide information regarding the feasibility of conducting a larger randomised control trial of non-pharmacological cognitive interventions of motor symptoms in PD.

ISRCTN, ISRCTN12565492. Registered 4 April 2018-retrospectively registered, in accordance with the WHO Trial Registration Data Set.