Parkinson's Pen Project
| ISRCTN | ISRCTN26683545 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26683545 |
| Secondary identifying numbers | 1 |
- Submission date
- 10/12/2014
- Registration date
- 16/01/2015
- Last edited
- 08/06/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
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
richard.walker@nhct.nhs.uk.
Contact information
Scientific
Department of Medicine
North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom
 ORCID ID |
0000-0002-9597-5446 |
|---|
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a participant information sheet |
| Scientific title | Developing a novel noninvasive aid for early diagnosis of Parkinson's disease: a feasibility study |
| 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(s) | NRES committee North East -York, 24/07/2014, ref. 14/NE/1037 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/02/2014 |
| Overall study end date | 31/07/2018 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 202 |
| 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 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
- England
- United Kingdom
Study participating centres
Rake Lane
North Shields
NE29 8NH
United Kingdom
NE9 6SX
United Kingdom
SR4 7TP
United Kingdom
DL6 1JG
United Kingdom
DL3 6HX
United Kingdom
Sponsor information
Hospital/treatment centre
North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
England
United Kingdom
| Website | https://www.northumbria.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/01gfeyd95 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 08/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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. |
| IPD sharing plan | The datasets generated during and/or analysed during the study are not expected to be made available because the data set contains both confidential and non-confidential information. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | 21/03/2014 | Yes | No | ||
| Protocol article | protocol | 01/05/2014 | Yes | No | |
| Abstract results | Presented at MDS Congress | 12/09/2020 | 08/06/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
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.
