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Parkinson’s pen project (PPP): Developing a novel non-invasive aid for early diagnosis of Parkinson’s disease


What is the purpose of the study?

Parkinson’s Disease (PD) is the second most common neurodegenerative condition in the UK and the main symptoms experienced by sufferers are resting tremor (shaking), rigidity (stiffness) and bradykinesia (slowness of movement).

At the moment if someone is suspected of having Parkinson’s disease they will be assessed and examined by a doctor specializing in Parkinson’s disease.  The doctor will then make a diagnosis based on their findings.  If the doctor is unable to make a decision then patients may be referred for a DaTSCAN.  A DaTSCAN takes images of the brain and provides further information for the doctor on which to base their decision.  However, DaTSCANs are expensive and take up a full day of the patient’s time.

Researchers at a number of universities across Europe (including Newcastle University) have developed a pen system (the Manus platform), which may help doctors to decide whether someone has Parkinson’s disease and, in some cases, may avoid the need for a DaTSCAN.

The pen is held like a normal pen and the person being assessed will be asked to perform a series of drawing and writing tasks on a flat screen.  A picture of the digital pen is shown below (top picture, with a normal writing pen shown below for scale).  In the lower picture, the pen is being demonstrated in use, with the person asked to trace out the shape of a circle shown on the screen.  The pen is slightly wider than a normal pen, but is held in the same way.

The assessment using the pen takes around 30-40 minutes and typical tasks include drawing a circle (as shown above), drawing a spiral and a star and writing a sentence.

Why have I been invited to take part?

You have been invited to take part in this study because you have been referred to your local movement disorders clinic.  We are contacting everyone referred to the service to ask if they would like to take part.

Do I have to take part?

No. It is up to you to decide whether or not to take part. If you do decide to take part we will give you a copy of this information sheet to keep. We will then ask you to sign a consent form. You are free to withdraw at any time and would not have to give a reason. A decision to withdraw at any time, or a decision to not take part, will have no effect on the care you receive.

What will happen to me if I take part?

If you are interested in taking part, then a research nurse will be available to answer any further questions you may have about the project when you attend clinic for your assessment.

We will then ask you to sign a consent form and give you a copy to keep.  If possible, we will arrange to assess you using the pen system that day as part of your clinic visit or visit for DaTSCAN assessment.  If this is not possible for whatever reason we can schedule another time convenient to you to come back and take part in the assessments.  All additional costs associated with travelling will be met.  A nurse will be present at all time during the assessment to answer any questions. If you wish to stop the assessment without completing it then you will be free to do this without needing to give a reason.

Once you have completed the assessments, your involvement in the study will be complete.

What are the possible risks/disadvantages of taking part?

The pen is used like a normal writing pen.  A number of movement sensors are contained within the pen and no sensors are placed anywhere on the body during assessment.  Previous studies of the pen conducted in the Netherlands and Ireland have not reported any adverse events.  Should you become tired or experience any muscle cramps or other pain from holding the pen you will be able to rest or stop the assessment.

What are the possible benefits of taking part?

There will be no direct beneft to you if you decide to take part in the study.  Your subsequent care will be completely unaffected.  However, the study will allow us to further assess the usefulness of the pen system in helping to diagnose Parkinson’s disease.  If the study is successful then future patients avoid the need to undergo DaTSCAN and may be diagnosed faster.  This is likely to result in substantial savings for the NHS and allow funds to be directed towards other areas of patient care.

Contact details:

Dr Uma Nath, Consultant Neurologist, Sunderland Royal Hospital, Chester Lodge, Sunderland, SR4 7TP. Tel: 0191 5656256

If the information in Part 1 has interested you, please continue to read the additional information in Part 2 before making any decision.


What will happen if I do not want to carry on with the study?

You can let us know at any time if you do not wish to be a part of the study. Your data will be entirely removed from our records if you request us to do so.

What if there is a problem?

With this type of study, problems are rare, as we will not be experimenting with pills or procedures. It is therefore normal practice in this type of study not to arrange any special arrangements for compensation.

If you have any cause for concern regarding your participation in the study please do not hesitate to contact the researcher (contact details listed in part one). If you still have concerns after this you may wish to complain formally. The NHS operated Patient Advice and Liaison Service (PALS) can provide guidance and assistance with any complaints or concerns: Freephone 0800 5876513. Email:

Will my taking part in this study be confidential?

All information collected about you in this study will be kept confidential. It is our duty in law to protect your personal information and all of our procedures for handling, processing, storing and destroying data are compliant with the Data Protection Act (1998).

If you participate the research team will allocate a number that will be used to identify you within the study.  On the computer collecting the information about your assessment only this number will identify you as the person being assessed.  All paper and electronic records linking your personal information to this number will be stored on NHS property within lockable filing cabinets and password protected NHS computers.  Only members of the Sunderland Parkinson’s disease service and research staff involved with the study will have access to your personal data.

Will my General Practitioner (GP) be involved?

We will inform your GP of your participation in our study.

What will happen to the results of the research study?

We will offer all the participants in the study a summary of our findings.  With your permission we will send you a written summary of our main findings.  You will also be invited to attend a feedback session after the study is completed where we will present the key findings and you will be able to ask any questions.  Attendance at these sessions will be voluntary.

Who is organising and funding the research?

The study is being organised by Northumbria Healthcare NHS Foundation Trust and is funded by the Technology Strategy Board.  The Technology Strategy Board are funded by the UK government and provide funding for innovative projects involving new technologies. The pen system is produced by Manus Neurodynamica Ltd, who were established by Dr Rutger Zietsma to look at the commercial potential of the system, which he helped develop as part of his PhD in bioengineering at Newcastle University.

Who has reviewed the study?

All research in the NHS is looked at by a Research Ethics Committee (an independent group of people). They are there to ensure that your safety, rights, wellbeing and dignity are protected.  The scientific merit and commercial potential of the project was reviewed by the Technology Strategy Board.

Further information and contact details

You can get more information on this study by contacting Professor Richard Walker: North Tyneside General Hospital, Rake Lane. North Shields. NE29 8NH. Telephone: 0191 293 2709

The local lead or Principal Investigator is Dr Uma Nath, Consultant Neurologist, Sunderland Royal Hospital, Chester Lodge, Sunderland, SR4 7TP. Tel: 0191 5656256.

Further information can also be obtained from Dr Barbara Wilson, Clinical Trials Officer, North-East DeNDRoN. Tel: 0191 208 1337

More information regarding research can be found online at the National Research Ethics Service website:   

For further independent information about being involved in a research study please contact the Patient Advice and Liaison Service (PALS):  Freephone 0800 5876513

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Parkinson’s pen project (PPP): Developing a novel non-invasive aid for early diagnosis of Parkinson’s disease

Researchers at a number of universities across Europe (including Newcastle University) have developed a pen system (the Manus platform), which may help doctors to decide whether someone has Parkinson’s disease. Find out more here.

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