TY - JOUR

T1 - Study protocol for a randomised pilot study of a computer-based, non-pharmacological cognitive intervention for motor slowing and motor fatigue in Parkinson’s disease

AU - Payne, Joshua

AU - Hindle, J.V.

AU - Pritchard, Aaron W.

AU - Davies, R.

AU - Coetzer, Bernardus

AU - d'Avossa, Giovanni

AU - Bracewell, Robert Martyn

AU - Leek, Charles

N1 - This trial was funded through the Betsi Cadwaladr University Health Board Pathway to Portfolio grant awarded to Prof. Charles Leek.

PY - 2018/12/26

Y1 - 2018/12/26

N2 - BackgroundParkinson’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.MethodsThe 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.DiscussionThe 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.

AB - BackgroundParkinson’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.MethodsThe 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.DiscussionThe 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.

KW - Parkinsons Disease

KW - Cognition

KW - COmputerised cognitive training

KW - Non-pharmacological intervention

KW - Motor symptons

KW - Fatigue

KW - Feasibility trial

U2 - 10.1186/s40814-018-0375-4

DO - 10.1186/s40814-018-0375-4

M3 - Article

VL - 4

JO - Pilot and Feasibility Studies

JF - Pilot and Feasibility Studies

SN - 2055-5784

M1 - 190

ER -