Parkinson Disease, IdiopathicPDRegistryNCT06609681
Parkinson Disease: A Model of National Digital Interventions to Prevent or Slow a Rise of Non-Communicable
An observational study of Parkinson Disease, Idiopathic, run by Roongrooj Bhidayasiri at 1 site in Thailand.
Trial summary
According to Parkinson's Disease Medical Center of Excellence's project which was registered Parkinson's disease patients in 2008-2011, it was found that there were more than 60,000 people with Parkinson's disease in Thailand, approximately 1 over 3 of all elderly people. Read more about this study
- Who is it for?
- Ages 40 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Idiopathic
- How many people
- 10,000 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2024to 31 Dec 2033
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: - Thai Adult age more than 40year old or have family history of Parkinson's disease
Who may be able to join
- Thai Adult age more than 40 years old.
- Family history with Parkinson's disease.
Who cannot join
- 1. Thai Adult age less than 40 years old
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Chulalongkorn Center of Excellence for Parkinson's disease and related to movement disorder
Pathum Wan, Bangkok, 10330
About this study
Official title: Flipping the Paradigm of Parkinson Disease: A Model of National Eat, Move, Sleep Digital Interventions to Prevent or Slow a Rise of Non-Communicable Diseases in Thailand
According to Parkinson's Disease Medical Center of Excellence's project which was registered Parkinson's disease patients in 2008-2011, it was found that there were more than 60,000 people with Parkinson's disease in Thailand, approximately 1 over 3 of all elderly people.
It is estimated that the prevalence of Parkinson's disease is approximately 242.57 per 100,000 people of all elderly people, and it is likely to increase due to the current situation of Thailand which is entering aging society. The current diagnosis of Parkinson's disease still relies heavily on medical history and physical examination. The accuracy of diagnosing Parkinson's disease by neurologists is approximately 80 percent, especially when they have been following up consistently. Nonetheless, if they have Parkinson's disease in the early stages, the signs and symptoms will not be severe. Therefore, diagnostic accuracy will decrease around 40-50 percent, making it difficult to diagnose Parkinson's disease patients at an early stage and as a consequence, there still are many undiagnosed patients in 2022. Consequently, Parkinson's Disease Medical Center of Excellence is planning to establish this pilot research project to develop and analyze advanced data of the screening system for people at risk and precursor symptoms to Parkinson's disease, Chulalongkorn Hospital, Thai Red Cross Society. Dividing patients into 3 groups, those who have precursor symptoms, who are at risk of developing disease and Parkinson's disease patients, using the digital platform on mobile application that includes general information, health information, congenital diseases, regularly used medications, initial abnormal symptoms, various risk factors, writing and handwriting, pronunciation assessments, and get diagnosis from experts for referral in the public health system.
Read the detailed description
- Flipping the Paradigm of Parkinson's Disease: A Model of National 'Eat, Move, Sleep' Digital Interventions to Prevent or Slow a Rise of Non-Communicable Diseases in Thailand
- Principal Investigator: Roongroj Bhidayasiri
- Study centers and Address: Chulalongkorn Center of Excellence for Parkinson's disease and related to movement disorder 1183 RAMA 4 Rd. Pathum wan, Bangkok 10330 and 76 provinces of Thailand.
The Screening of Parkinson's patients with digital technology and sensors and analyze with artificial intelligence the following information
- Innovative prototype questionnaire. Screening of Parkinson's patients with digital technology.
- Sound screening that can detect speech
- Handwriting test by writing sentences and spiral circles.
- Testing finger dexterity and alternating tap test
- Tremor analysis
- Gait analysis
- Assessing your ability to get out of bed
- Sleep quality
- Sleep assessment by polysomnography test
- Ability to smell
- Conditions
- Parkinson Disease, Idiopathic
- Keywords
- Thai Parkinson Screening. Registry.
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital platform system; Motor and non-motor symptom of Parkinson' s disease questionnaire, tremor and voice test
a web-based structural software package that speeds and eases transactions among users. Digital platforms serve digital markets, while also offering physical products.
Measured: 1 year
Secondary outcomes (2)
Age
the number of years that someone has lived, or that something has existed
Measured: 1 year
Early Lifestyle interventions Eat Move Sleep
Early detection, especially for early PD, prodromal PD, and individuals at risk for PD.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Jan 2024
- Primary completion1 Nov 2024 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease, IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Roongrooj Bhidayasiri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Roongrooj Bhidayasiri, Chulalongkorn Centre of Excellence for Parkinson's Disease and Related Disorders
- Investigators
- Professor Roongroj Bhidayasiri, M.D., Principal investigator, Chulalongkorn Centre of Excellence for Parkinson's Disease and Related Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609681
- Sponsor's protocol ID
- Med Chula IRB No.0804/65
- Other IDs
- GCE 3300160003
- Acronym
- PDRegistry
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flipping the Paradigm of Parkinson Disease: A Model of National Eat, Move, Sleep Digital Interventions to Prevent or Slow a Rise of Non-Communicable Diseases in Thailand
- ClinicalTrials.gov ID
- NCT06609681
- Acronym / sponsor ID
- PDRegistry / Med Chula IRB No.0804/65
- Conditions
- Parkinson Disease, Idiopathic
- Keywords
- Thai Parkinson Screening. Registry.
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Roongrooj BhidayasiriUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
According to Parkinson's Disease Medical Center of Excellence's project which was registered Parkinson's disease patients in 2008-2011, it was found that there were more than 60,000 people with Parkinson's disease in Thailand, approximately 1 over 3 of all elderly people.
It is estimated that the prevalence of Parkinson's disease is approximately 242.57 per 100,000 people of all elderly people, and it is likely to increase due to the current situation of Thailand which is entering aging society. The current diagnosis of Parkinson's disease still relies heavily on medical history and physical examination. The accuracy of diagnosing Parkinson's disease by neurologists is approximately 80 percent, especially when they have been following up consistently. Nonetheless, if they have Parkinson's disease in the early stages, the signs and symptoms will not be severe. Therefore, diagnostic accuracy will decrease around 40-50 percent, making it difficult to diagnose Parkinson's disease patients at an early stage and as a consequence, there still are many undiagnosed patients in 2022. Consequently, Parkinson's Disease Medical Center of Excellence is planning to establish this pilot research project to develop and analyze advanced data of the screening system for people at risk and precursor symptoms to Parkinson's disease, Chulalongkorn Hospital, Thai Red Cross Society. Dividing patients into 3 groups, those who have precursor symptoms, who are at risk of developing disease and Parkinson's disease patients, using the digital platform on mobile application that includes general information, health information, congenital diseases, regularly used medications, initial abnormal symptoms, various risk factors, writing and handwriting, pronunciation assessments, and get diagnosis from experts for referral in the public health system.
Detailed description
- Flipping the Paradigm of Parkinson's Disease: A Model of National 'Eat, Move, Sleep' Digital Interventions to Prevent or Slow a Rise of Non-Communicable Diseases in Thailand
- Principal Investigator: Roongroj Bhidayasiri
- Study centers and Address: Chulalongkorn Center of Excellence for Parkinson's disease and related to movement disorder 1183 RAMA 4 Rd. Pathum wan, Bangkok 10330 and 76 provinces of Thailand.
The Screening of Parkinson's patients with digital technology and sensors and analyze with artificial intelligence the following information
- Innovative prototype questionnaire. Screening of Parkinson's patients with digital technology.
- Sound screening that can detect speech
- Handwriting test by writing sentences and spiral circles.
- Testing finger dexterity and alternating tap test
- Tremor analysis
- Gait analysis
- Assessing your ability to get out of bed
- Sleep quality
- Sleep assessment by polysomnography test
- Ability to smell
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- - Thai Adult age more than 40year old or have family history of Parkinson's disease
Key inclusion criteria (2 listed)
- Thai Adult age more than 40 years old.
- Family history with Parkinson's disease.
Key exclusion criteria (1 listed)
- 1. Thai Adult age less than 40 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Digital platform system; Motor and non-motor symptom of Parkinson' s disease questionnaire, tremor and voice test
Time frame: 1 year
a web-based structural software package that speeds and eases transactions among users. Digital platforms serve digital markets, while also offering physical products.
2 secondary outcomes
Age
Time frame: 1 year
Early Lifestyle interventions Eat Move Sleep
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Roongroj Bhidayasiri, M.D. principal investigator
Chulalongkorn Centre of Excellence for Parkinson's Disease and Related Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, Idiopathic, run by Roongrooj Bhidayasiri at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital platform system; Motor and non-motor symptom of Parkinson' s disease questionnaire, tremor and voice test (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.