Feasibility study of electronic pen to help early diagnosis of dementia
| ISRCTN | ISRCTN11610863 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11610863 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 303834 |
| Protocol serial number | CPMS 52890, IRAS 303834 |
| Sponsor | Northumbria Healthcare NHS Foundation Trust |
| Funders | Innovate UK, Manus Neurodynamica Ltd |
- Submission date
- 07/09/2023
- Registration date
- 16/10/2023
- Last edited
- 16/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
There are currently over 800,000 people with dementia in the U.K. Improving ability to diagnose dementia in its earlier stages and accurately can help ensure patients access appropriate treatment and support.
Researchers at a number of universities across Europe (including Newcastle University) have developed a pen system which assesses changes in movement and ability to write and draw. We are looking to study whether the pen system may help identify dementia and different types of dementia
Who can participate?
Those referred to North Tyneside memory clinic and local age matched individuals as controls.
What does the study involve?
Completing a series of basic drawing tests using the electronic pen on a touch sensitive tablet.
What are the possible benefits and risks of participating?
The pen is similar to a normal writing pen but it contains some sensors which detect movement. Previous studies of the pen conducted in the U.K., Netherlands and Ireland have not reported any adverse events.
There will be no direct benefit to participants. However, the study will allow us to assess whether the pen system could be used in a memory clinic setting and help identify dementia. If the study is successful then there may be potential for the pen to improve diagnosis of dementia and different types of dementia
Where is the study run from?
North Tyneside General Hospital (UK)
When is the study starting and how long is it expected to run for?
October 2022 to June 2024
Who is funding the study?
1. Innovate UK
2. Manus Neurodynamica Ltd (UK)
Who is the main contact?
Dr Christopher Davison, Christopher.davison@nhct.nhs.uk
Contact information
Scientific
Northumbria Healthcare NHS Foundation Trust
North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom
 ORCID ID |
0000-0001-6509-7059 |
|---|---|
| Christopher.davison@nhct.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomized; Interventional; Design type: Screening, Process of Care, Device |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Evaluation of Neuromotor Pen in early identification of dementia and differential of dementia subtypes: a feasibility study |
| Study objectives | We are testing a novel, user-friendly and inexpensive pen system to aid in the differential diagnosis of dementia. It is hypothesized that the pen system can be developed to differentiate between dementia, MCI and normal subjects as well as potentially differentiating dementia subtype |
| Ethics approval(s) |
Approved 17/10/2022, South East Scotland REC2 (2ndFloor, Waverley Gate, 2-4 Waterloo Place, Edinburgh, EH1 3EG, United Kingdom; +44 131 5369000; ruth.fraser4@nhslothian.scot.nhs.uk), ref: 22/SS/0039 |
| Health condition(s) or problem(s) studied | Dementia |
| Intervention | Patients and carers will be consented to perform a series of written/drawing tests using the NMP taking between 5 and 15 minutes. These will be incorporated into memory clinic assessment with patients consent. Rating of acceptability of testing will be tested with a basic questionnaire and rating scales. Results of tests will be compared to tests results from the memory clinic assessment so not to add significant extra time to assessments and to compare with normal practice. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Neuromotor Pen |
| Primary outcome measure(s) |
The level of agreement between the pen system and clinical diagnosis. The assessment by a specialist clinician will be conducted as part of routine assessment of suspected dementia |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 01/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Capacitated individuals attending memory clinic for assessment of possible dementia 2. Carers may be invited to act as controls 3. Willing and able to provide written informed consent 4. Aged 18 years or older |
| Key exclusion criteria | 1. Lack of capacity 2. Significant visual impairment 3. Significant upper limb physical functional impairment 4. Under 18 years old 5. Unable to communicate in English |
| Date of first enrolment | 19/12/2022 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
North Shields
NE29 8NH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1.3 | 11/07/2023 | 03/10/2023 | No | No |
Additional files
- 44251 Protocol V1.3.pdf
- Protocol file
Editorial Notes
07/09/2023: Study's existence confirmed by the NIHR.
