Condition category
Nervous System Diseases
Date applied
10/12/2014
Date assigned
16/01/2015
Last edited
16/01/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 February 2017

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

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

Trial website

Contact information

Type

Scientific

Primary contact

Professor Richard Walker

ORCID ID

http://orcid.org/0000-0002-9597-5446

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

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

Acronym

PPP

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

Observational

Secondary study design

Study of diagnostic accuracy

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

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

Condition

Parkinson's disease

Intervention

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

Device

Phase

Drug names

Primary outcome measures

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

01/02/2014

Overall trial end date

01/02/2017

Reason abandoned

Eligibility

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

Mixed

Age group

All

Gender

Both

Target number of participants

202

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

01/02/2015

Recruitment end date

01/07/2016

Locations

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

Organisation

Northumbria Healthcare NHS Foundation Trust

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

https://www.northumbria.nhs.uk/

Funders

Funder type

Not defined

Funder name

Technology Strategy Board

Alternative name(s)

TSB

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

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

Results - basic reporting

Publication summary

We have published a peer-reviewed article which describes the background to the study.

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