Parkinson's Pen Project

Plain English summary of protocol

Background and study aims
Parkinson’s disease (PD) is a chronic condition where nerve cells in a small part of the brain called the substantia nigra become damaged and die. The nerve cells in this region send signals that controls the muscles of the body. Dopamine is the main neurotransmitter produced by these nerve cells. As more of these cells die, the amount of dopamine produced also falls. Over time, the lack of nerve cells and low levels of dopamine affects how well the person affected can control their muscles. The most common symptoms of the condition are slowness of movement, muscle stiffness and shaking (tremors). PD affects both the fine control of the fingers and larger movement of the upper limb. Handwriting tests are commonly performed as part of the initial assessment of people suspected of having PD and can help doctors diagnose the condition. Diagnosis of PD is normally done by a specialist, based on signs and symptoms. In more difficult cases, brain imaging (DaTSCAN) can be carried out to help with the diagnosis. However, this is expensive (approximately £1000 per scan) and can be an unpleasant experience for patients. We want to test the usefulness of a novel digital pen system (the Manus platform) to help doctors diagnose PD.

Who can participate?
Patients that have been referred to one of 5 NHS Healthcare Trusts in the North East for possible Parkinson’s disease.

What does the study involve?
Participants are asked to perform a number of simple writing and drawing tasks using the Manus platform, which includes a digital pen on a flat digital screen. The test takes about 20-30 minutes to do. The system then uses a number of automated mathematical methods to diagnose PD. The ability of the system to diagnose PD accurately is then investigated compared to current best practice diagnosis of clinical opinion or DaTSCAN.

What are the possible benefits and risks of participating?
There will be no direct benefit to patients included in the study and their subsequent care will be unaffected by their participation. However, if the trial proves successful, we envisage that, in the foreseeable future, use of the digital pen system during assessment for PD may avoid the need for DaTSCAN in some patients. The risks for a patient recruited to the study are thought to be low. They will perform a series of drawing and writing tasks for 20-30 minutes in total. Although unlikely, some patients may experience fatigue or discomfort during the tasks. Patients will be free to stop at any point and either rest and resume the tasks or not complete the tasks and leave the study. Those who do not complete the tasks will not need to give a reason.

Where is the study run from?
Five NHS Healthcare Trusts in North East England (UK)

When is the study starting and how long is it expected to run for?
February 2014 to July 2018

Who is funding the study?
Technology Strategy Board (UK)

Who is the main contact?
Professor Richard Walker
richard.walker@nhct.nhs.uk.

Contact information

Prof Richard Walker
Scientific

Department of Medicine
North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom

ORCID ID	0000-0002-9597-5446

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England

Study participating centres

Results and Publications

Study outputs

Editorial Notes

08/06/2022: The following changes have been made:
1. An abstract has been added to the trial outputs.
2. An IPD sharing statement has been added.
3. The intention to publish date has been changed from 01/02/2018 to 08/06/2023.
16/05/2022: No publications found, verifying study status with principal investigator.
07/02/2018: The overall trial end date was changed from 01/02/2017 to 31/07/2018.
30/11/2017: Publication reference added.