Stomach function in Parkinson’s disease: a feasibility study
| ISRCTN | ISRCTN87623941 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87623941 |
| IRAS number | 2024 EXP 20400 |
| Secondary identifying numbers | 2024 EXP 20400 |
- Submission date
- 09/01/2025
- Registration date
- 13/01/2025
- Last edited
- 11/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Parkinson’s disease (PD) is the second most common neurodegenerative disease and affects 1% of people over the age of 60 years in industrialised countries. In Aotearoa New Zealand, the number has increased from about 7,000 in 2006 to about 11,000 in 2020.
There is significant diversity in symptoms in people with PD which encompass the conventional movement symptoms including tremor and rigidity. Over the past decade, there has been increasing recognition that non-movement symptoms have a more profound and negative impact on quality of life and wellbeing than movement problems in PD. Many of these affect the digestive system including the stomach, and these symptoms can impair dietary intake and negatively impact nutritional health.
This study aims to explore how feasible it is to conduct a study investigating the use of a device (body surface gastric mapping) to explore gastric (stomach) symptoms in people with PD.
Who can participate?
Patients aged 18 years and over with PD
What does the study involve?
Each participant is invited to one visit only. Participants will be asked to fast overnight for 6-8 hours and to arrive at the University of Auckland in the morning time at a pre-arranged time. They are asked to take all of their usual medications at home before their visit and to bring any medications to take during the visit. They are welcome to bring a member of their family, a caregiver, whānau or friend to the visit and they can stay with the participant during the visit.
Height, weight and blood pressure will be measured and participants will be asked some questions and also to complete a number of questionnaires about their PD. Some measurements will be taken to record their movement.
They will be asked to recline on a comfortable chair and a device will be placed on the stomach that measures electrical responses. This is called a body surface gastric mapping device. The sensors are non-invasive, and participants are unlikely to feel much when measurements are being taken. The sensors are positioned and worn like an item of clothing. Participants are given a meal of a muesli bar and a milky drink and measurements will be taken for the next 4 hours. When the study is over, participants and caregivers will be offered lunch before going home.
What are the possible risks and benefits of participating?
The results will help to inform the development of further studies and trials. There are no significant benefits and no significant risks.
Where is the study run from?
The study is being run from the Liggins Institute at the University of Auckland (New Zealand)
When is the study starting and how long is it expected to run for?
May 2023 to August 2025
Who is funding the study?
1. Health Research Council of New Zealand
2. University of Auckland (New Zealand)
Who is the main contact?
Dr Fiona Lithander, fiona.lithander@auckland.ac.nz
Contact information
Principal Investigator
Liggins Institute
University of Auckland
85 Park Road
Grafton
Auckland
1123
New Zealand
| Phone | +64 (0)99236691 |
|---|---|
| fiona.lithander@auckland.ac.nz |
Study information
| Study design | Observational feasibility study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Feasibility |
| Study setting(s) | University/medical school/dental school |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Gastric function in Parkinson’s disease: a feasibility study |
| Study acronym | GastricPD |
| Study objectives | To test the feasibility of the use of a medical technology (body surface gastric mapping and symptom tracking) to measure gastric symptoms and electrophysiology in Parkinson's disease. |
| Ethics approval(s) |
Approved 23/05/2023, Southern Health and Disability Ethics Committee (133 Molesworth Street, Wellington, 6011, New Zealand; +64 (0)4 496 2000; hdec@health.govt.nz), ref: 2024 EXP 20400 |
| Health condition(s) or problem(s) studied | Parkinson's disease |
| Intervention | Each participant is invited to one visit only. Participants will be asked to fast overnight for 6-8 hours and to arrive at the University of Auckland in the morning time at a pre-arranged time. They are asked to take all of their usual medications at home before their visit and to bring any medications to take during the visit. They are welcome to bring a member of their family, a caregiver, whānau or friend to the visit and they can stay with the participant during the visit. Height, weight and blood pressure will be measured and participants will be asked some questions and also to complete a number of questionnaires about their PD. Some measurements will be taken to record their movement. They will be asked to recline on a comfortable chair and a device will be placed on the stomach that measures electrical responses. This is called a body surface gastric mapping device. The sensors are non-invasive, and participants are unlikely to feel much when measurements are being taken. The sensors are positioned and worn like an item of clothing. Participants are given a meal of a muesli bar and a milky drink and measurements will be taken for the next 4 hours. When the study is over, participants and caregivers will be offered lunch before going home. |
| Intervention type | Other |
| Primary outcome measure | 1. Recruitment rate, number of eligible participants, and length of time taken to recruit 10 participants measured using standard questions by 6 months. 2. Feasibility and acceptability of the measurement of gastric symptoms using the body surface gastric mapping device in 10 participants using existing questions by 6 months |
| Secondary outcome measures | 1. Participant acceptability of completion of questionnaires listed here, assessed using standard questions at baseline 2. Quality of life measured using Parkinson’s Disease Questionnaire 8 at baseline 3. Motor and non-motor symptoms measured using the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS UPDRS) at baseline 4. Non-motor symptoms measured using the Movement Disorder Society Non-Motor Symptom Rating Scale (MDS NMS) at baseline 5. Gastrointestinal symptoms measured using the Gastrointestinal Symptom Rating Scale at baseline 6. Gastrointestinal symptoms measured using the MDS Gastrointestinal Dysfunction Scale for Parkinson’s Disease at baseline 7. Dietary intake measured using intake24 at baseline 8. Gastric electrophysiological and symptom response to a standard test meal in Parkinson’s up to 4 hours post consumption of the test meal compared with a matched control group |
| Overall study start date | 23/05/2023 |
| Completion date | 30/08/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 10 |
| Total final enrolment | 10 |
| Key inclusion criteria | 1. Aged ≥18 years 2. A diagnosis of idiopathic PD, diagnosed by a neurologist 3. Available to attend the Liggins Institute at the Grafton campus of the University of Auckland 4. The mental capacity to consent to participate in this research |
| Key exclusion criteria | 1. People with medical, cognitive, or psychosocial issues that would preclude compliance with the protocol, confirmed by a principal investigator or neurologist 2. Co-enrolment in another study or trial that, in the opinion of the principal investigators, would interfere with adherence to study requirements |
| Date of first enrolment | 04/02/2025 |
| Date of final enrolment | 12/05/2025 |
Locations
Countries of recruitment
- New Zealand
Study participating centre
Grafton
Auckland
1123
New Zealand
Sponsor information
University/education
Private Bag 92019
Auckland
1142
New Zealand
| Phone | +64 (0)99236691 |
|---|---|
| dana.wensley@auckland.ac.nz | |
| Website | https://www.auckland.ac.nz/ |
"ROR" |
https://ror.org/03b94tp07 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- HRCNewZealand, HRC New Zealand, HRC
- Location
- New Zealand
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Auckland, New Zealand, UoA
- Location
- New Zealand
Results and Publications
| Intention to publish date | 30/08/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from the principal investigator Dr Fiona Lithander (fiona.lithander@auckland.ac.nz) |
Editorial Notes
11/07/2025: The date of final enrolment was changed from 30/06/2025 to 12/05/2025. Total final enrolment added.
31/01/2025: The recruitment start date was changed from 27/01/2025 to 04/02/2025.
10/01/2025: Study's existence confirmed by Southern Health and Disability Ethics Committee.
