Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

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

Trial website

Contact information



Primary contact

Prof Richard Walker


Contact details

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

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Developing a novel noninvasive aid for early diagnosis of Parkinson's disease: a feasibility study



Study hypothesis

We will test a novel, user-friendly and inexpensive system to aid in the differential diagnosis of Parkinson’s disease (PD). It is hypothesized that the system can differentiate between PD patients, healthy subjects, and those with other related conditions, such as essential tremor, with a sensitivity of 90% and a specificity of 80%.

Ethics approval

NRES committee North East -York, 24/07/2014, ref. 14/NE/1037

Study design

Feasibility study of the clinical usefulness of an aid to diagnosis of Parkinson's disease

Primary study design


Secondary study design

Study of diagnostic accuracy

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet


Parkinson's disease


The Manus platform is a novel sensor system with automated mathematical methods, integrated with a digital pen, for differential diagnosis of PD that allows an objective assessment of handwriting. The person being assessed performs series of simple writing and drawing tasks using the pen on a flat digital screen. The assessment takes 20-30 minutes.

Intervention type



Drug names

Primary outcome measure

It is anticipated that a sensitivity of 90% and specificity of 80% can be obtained.

Secondary outcome measures

Acceptability of the Manus Platform to users.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Patients that have been referred for possible Parkinson's disease to one of five NHS Healthcare Trusts in North East England
2. Healthy age-matched controls will be included to help assess specificity. These will be recruited from any spouses of patients who volunteer to be tested

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Unable to give fully informed consent for any reason
2. Unable to hold the assessment pen for any reason
3. Significant cognitive impairment based on Montreal Cognitive Assessment score
4. Presence of a pacemaker

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Northumbria Healthcare NHS Foundation Trust
North Tyneside General Hospital Rake Lane
North Shields
NE29 8NH
United Kingdom

Trial participating centre

Gateshead Health NHS Foundation Trust
United Kingdom

Trial participating centre

City Hospitals Sunderland NHS Foundation Trust
United Kingdom

Trial participating centre

South Tees Hospitals NHS Foundation Trust
United Kingdom

Trial participating centre

County Durham and Darlington NHS Foundation Trust
United Kingdom

Sponsor information


Northumbria Healthcare NHS Foundation Trust

Sponsor details

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

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Innovate UK (ex Technology Strategy Board)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

We hope that the study will results in a number of publications in academic peer reviewed journals in the area of Parkinson's disease. In addition, within 6 months of the end of the data collection period, we will provide a detailed written report on key findings and provide feedback to study participants via a short summary report. Participants will also be invited to attend one of three feedback sessions held near their local PD clinic within 9 months of the end of data collection.

Intention to publish date


Participant level data

Not expected to be available

Basic results (scientific)

Publication list

1. 2014 protocol in
Walker RW, Zietsma R, Gray WK. Could a new sensory pen assist in the early diagnosis of Parkinson’s? Expert Rev Med Devices. 2014;published online 24th March 2014 (doi: 10.1586/17434440.2014.900437).

Publication citations

Additional files

Editorial Notes

07/02/2018: The overall trial end date was changed from 01/02/2017 to 31/07/2018. 30/11/2017: Publication reference added.