Parkinson DiseaseNCT04970745
Application of Tremor Analysis in Parkinson's Disease and Its Related Diseases
An observational study of Parkinson Disease, run by Peking University Third Hospital at 1 site in China.
Trial summary
This is a longitudinal study to evaluate the brainstem of patients at different stages through VEMP neck, masticatory muscle and eye tests on patients with early and middle-advanced PD (20 cases each) and healthy controls (40 cases) The function of various parts is affected. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Transcranial parenchymal color Doppler ultrasound (TCS) and Electromyography (EMG) tremor analysis
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson's disease, the second most common neurodegenerative disease, affects 1 to 2 percent of patients over 65 years of age. China currently has nearly 2 million patients with Parkinson's disease, and the number is expected to grow exponentially in the coming years. The clinical manifestations of Parkinson's disease include tremor, rigidity, bradykinesia, postural instability and other motor symptoms. The static tremor is caused by cerebellum and basal ganglia circuits, which has nothing to do with the number of dopamine neurons. Treatment with Mdopa can reduce the tremor amplitude of patients, but generally does not change the tremor frequency.
Who may be able to join
- Enrollment criteria: All patients from the outpatient and inpatient department of neurological movement disorders, aged 45-75 years, meet the following symptom scores greater than or equal to 4 points: olfactory disorder (2 points), rapid eye movement sleep behavior disorder (2 points) , Constipation (1 point), anxiety and depression symptoms (1 point), muscle stiffness (1 point), tremor (1 point), balance disorder (1 point), signed informed consent;
Who cannot join
- exclusion criteria: a. Clear cerebellar abnormalities; b. Downward vertical supranuclear gaze palsy, or selective downward vertical saccade slowed down; c. Within the first 5 years of onset, diagnosed as possible behavioral variant frontotemporal dementia or primary Progressive aphasia; d. The onset of Parkinson's syndrome that is still limited to the lower limbs for 3 years; e. Parkinson's syndrome caused by drugs; f. The effect of levodopa is not good; g. Cortical sensory loss.
Trial locations and contacts
1 site in 1 country.
About this study
This is a longitudinal study to evaluate the brainstem of patients at different stages through VEMP neck, masticatory muscle and eye tests on patients with early and middle-advanced PD (20 cases each) and healthy controls (40 cases) The function of various parts is affected. At the same time, combining the patient's neurological function score and non-motor symptom score to find evidence of early involvement and early intervention.
Read the detailed description
[Background] Tremor is an important symptom of extrapyramidal diseases, and it is also an early symptom of a variety of complex diseases. The classification of tremor has not been completely unified, mainly including essential tremor, Parkinson's disease tremor, etc., each form of tremor has Crossover and connection make clinical differential diagnosis difficult. At the same time, many diseases related to tremor lack pathological, serological and imaging characteristic changes. Therefore, it is particularly important to find accurate and objective evaluation indicators for tremor.
By recording a pair of antagonist muscles (active muscles and passive muscles), electromyography can objectively record the type, degree, amplitude, burst pattern (whether the burst activity of the antagonistic muscles are synchronized or alternate), and weight-bearing The effect of drugs on tremor is very valuable for the diagnosis and differential diagnosis of tremor; especially for patients with Parkinson's disease, it can be several years or even decades before they develop motor symptoms, that is, tremor, rigidity, slowness of movement, and postural instability. There are a wide range of non-motor symptoms, such as smell, mood, sleep, mental behavior and many other aspects. Compared with dyskinesia, non-motor symptoms are both a precursor to the onset and an indication of disease progression. Fully understanding and exploring the law of the occurrence and development of these non-motor symptoms can provide clues for our early diagnosis and provide us with opportunities for early implementation of neuroprotective treatment.
The early clinical symptoms of Parkinson's disease (Pakinson's disease, PD) are often atypical, and it is difficult to diagnose it only based on the history and clinical manifestations. However, when the diagnosis is made when the clinical symptoms are obvious, the patient's substantia nigra dopamine neurons have been reduced by 60-70%, and the opportunity for early treatment is lost. A Berg study also showed that treatment when most neurons in the pre-exercise period have not undergone degeneration can better protect the nerves and may delay the clinical progress of PD. Therefore, early diagnosis and early treatment of PD patients are particularly important.
The clinical manifestations of Parkinson's disease include motor symptoms and non-motor symptoms (NMS), the latter of which is often ignored by clinicians. It includes common neuropsychiatric symptoms: such as depression, anxiety, apathy, lack of affect, distraction, and even hallucinations, delusions, delusions, dementia, obsessive-compulsive symptoms, panic attacks; sleep disorders: periodic limb movement disorders, excessive sleep during the day and so on. Some of these symptoms can appear before the movement disorder of Parkinson's disease, some are accompanied by the movement disorder, and some appear in the middle and late stages of Parkinson's disease, and aggravate with the aggravation of the movement symptoms. And its NMS is closely related to the severity of the entire disease of PD.
[Objective] To explore the significance of tremor analysis in judging the early diagnosis of Parkinson's disease.
Discuss the significance of tremor analysis for the prognosis of the disease. To explore the diagnostic significance of tremor analysis in patients with Parkinson's disease and benign tremor.
[Design] This is a longitudinal study to evaluate the brainstem of patients at different stages through VEMP neck, masticatory muscle and eye tests on patients with early and middle-advanced PD (20 cases each) and healthy controls (40 cases) The function of various parts is affected. At the same time, combining the patient's neurological function score and non-motor symptom score to find evidence of early involvement and early intervention.
- Conditions
- Parkinson Disease
- Being tested
- Transcranial parenchymal color Doppler ultrasound (TCS), Electromyography (EMG) tremor analysis
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial parenchymal color Doppler ultrasound (TCS)Other
tracing the nigrostriatal echogenic area
Electromyography (EMG) tremor analysisOther
observed 1, frequency 2, amplitude (amplitude) 3, correlation between the two sides 4, load and post-drug test differences
| Study group | Role | What they receive |
|---|---|---|
| high-risk | After performing midbrain ultrasound and tremor analysis, patients with positive results of both tests are considered very high-risk patients, Receives: Other: Transcranial parenchymal color Doppler ultrasound (TCS); Other: Electromyography (EMG) tremor analysis | |
| risk | After performing midbrain ultrasound and tremor analysis, patients with positive results of 1 out of 2 tests are considered risk patients Receives: Other: Transcranial parenchymal color Doppler ultrasound (TCS); Other: Electromyography (EMG) tremor analysis | |
| low-risk | After performing midbrain ultrasound and tremor analysis, patients with negative results of both tests are considered risk patients Receives: Other: Transcranial parenchymal color Doppler ultrasound (TCS); Other: Electromyography (EMG) tremor analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
nigrostriatal echogenic area
using the Transcranial parenchymal color Doppler ultrasound (TCS) to trace the nigrostriatal echogenic area
Measured: 1 week after enrollment
Electromyography (EMG) tremor analysis
EMG frequency
Measured: 1 week after enrollment
Electromyography (EMG) tremor analysis
EMG amplitude (amplitude)
Measured: 1 week after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Jan 2018
- Primary completion30 Jun 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoxuan Liu, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970745
- Sponsor's protocol ID
- M2018222
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Tremor Analysis in Parkinson's Disease and Its Related Diseases
- ClinicalTrials.gov ID
- NCT04970745
- Acronym / sponsor ID
- M2018222
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 21 Jul 2021 (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.
This is a longitudinal study to evaluate the brainstem of patients at different stages through VEMP neck, masticatory muscle and eye tests on patients with early and middle-advanced PD (20 cases each) and healthy controls (40 cases) The function of various parts is affected. At the same time, combining the patient's neurological function score and non-motor symptom score to find evidence of early involvement and early intervention.
Detailed description
[Background] Tremor is an important symptom of extrapyramidal diseases, and it is also an early symptom of a variety of complex diseases. The classification of tremor has not been completely unified, mainly including essential tremor, Parkinson's disease tremor, etc., each form of tremor has Crossover and connection make clinical differential diagnosis difficult. At the same time, many diseases related to tremor lack pathological, serological and imaging characteristic changes. Therefore, it is particularly important to find accurate and objective evaluation indicators for tremor.
By recording a pair of antagonist muscles (active muscles and passive muscles), electromyography can objectively record the type, degree, amplitude, burst pattern (whether the burst activity of the antagonistic muscles are synchronized or alternate), and weight-bearing The effect of drugs on tremor is very valuable for the diagnosis and differential diagnosis of tremor; especially for patients with Parkinson's disease, it can be several years or even decades before they develop motor symptoms, that is, tremor, rigidity, slowness of movement, and postural instability. There are a wide range of non-motor symptoms, such as smell, mood, sleep, mental behavior and many other aspects. Compared with dyskinesia, non-motor symptoms are both a precursor to the onset and an indication of disease progression. Fully understanding and exploring the law of the occurrence and development of these non-motor symptoms can provide clues for our early diagnosis and provide us with opportunities for early implementation of neuroprotective treatment.
The early clinical symptoms of Parkinson's disease (Pakinson's disease, PD) are often atypical, and it is difficult to diagnose it only based on the history and clinical manifestations. However, when the diagnosis is made when the clinical symptoms are obvious, the patient's substantia nigra dopamine neurons have been reduced by 60-70%, and the opportunity for early treatment is lost. A Berg study also showed that treatment when most neurons in the pre-exercise period have not undergone degeneration can better protect the nerves and may delay the clinical progress of PD. Therefore, early diagnosis and early treatment of PD patients are particularly important.
The clinical manifestations of Parkinson's disease include motor symptoms and non-motor symptoms (NMS), the latter of which is often ignored by clinicians. It includes common neuropsychiatric symptoms: such as depression, anxiety, apathy, lack of affect, distraction, and even hallucinations, delusions, delusions, dementia, obsessive-compulsive symptoms, panic attacks; sleep disorders: periodic limb movement disorders, excessive sleep during the day and so on. Some of these symptoms can appear before the movement disorder of Parkinson's disease, some are accompanied by the movement disorder, and some appear in the middle and late stages of Parkinson's disease, and aggravate with the aggravation of the movement symptoms. And its NMS is closely related to the severity of the entire disease of PD.
[Objective] To explore the significance of tremor analysis in judging the early diagnosis of Parkinson's disease.
Discuss the significance of tremor analysis for the prognosis of the disease. To explore the diagnostic significance of tremor analysis in patients with Parkinson's disease and benign tremor.
[Design] This is a longitudinal study to evaluate the brainstem of patients at different stages through VEMP neck, masticatory muscle and eye tests on patients with early and middle-advanced PD (20 cases each) and healthy controls (40 cases) The function of various parts is affected. At the same time, combining the patient's neurological function score and non-motor symptom score to find evidence of early involvement and early intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high-risk | – | Other: Transcranial parenchymal color Doppler ultrasound (TCS), Other: Electromyography (EMG) tremor analysisAfter performing midbrain ultrasound and tremor analysis, patients with positive results of both tests are considered very high-risk patients, |
| risk | – | Other: Transcranial parenchymal color Doppler ultrasound (TCS), Other: Electromyography (EMG) tremor analysisAfter performing midbrain ultrasound and tremor analysis, patients with positive results of 1 out of 2 tests are considered risk patients |
| low-risk | – | Other: Transcranial parenchymal color Doppler ultrasound (TCS), Other: Electromyography (EMG) tremor analysisAfter performing midbrain ultrasound and tremor analysis, patients with negative results of both tests are considered risk patients |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's disease, the second most common neurodegenerative disease, affects 1 to 2 percent of patients over 65 years of age. China currently has nearly 2 million patients with Parkinson's disease, and the number is expected to grow exponentially in the coming years. The clinical manifestations of Parkinson's disease include tremor, rigidity, bradykinesia, postural instability and other motor symptoms. The static tremor is caused by cerebellum and basal ganglia circuits, which has nothing to do with the number of dopamine neurons. Treatment with Mdopa can reduce the tremor amplitude of patients, but generally does not change the tremor frequency.
Key inclusion criteria (1 listed)
- Enrollment criteria: All patients from the outpatient and inpatient department of neurological movement disorders, aged 45-75 years, meet the following symptom scores greater than or equal to 4 points: olfactory disorder (2 points), rapid eye movement sleep behavior disorder (2 points) , Constipation (1 point), anxiety and depression symptoms (1 point), muscle stiffness (1 point), tremor (1 point), balance disorder (1 point), signed informed consent;
Key exclusion criteria (1 listed)
- exclusion criteria: a. Clear cerebellar abnormalities; b. Downward vertical supranuclear gaze palsy, or selective downward vertical saccade slowed down; c. Within the first 5 years of onset, diagnosed as possible behavioral variant frontotemporal dementia or primary Progressive aphasia; d. The onset of Parkinson's syndrome that is still limited to the lower limbs for 3 years; e. Parkinson's syndrome caused by drugs; f. The effect of levodopa is not good; g. Cortical sensory loss.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial parenchymal color Doppler ultrasound (TCS)tracing the nigrostriatal echogenic area | Other | high-risk, low-risk, risk |
| Electromyography (EMG) tremor analysisobserved 1, frequency 2, amplitude (amplitude) 3, correlation between the two sides 4, load and post-drug test differences | Other | high-risk, low-risk, risk |
Primary outcome
nigrostriatal echogenic area
Time frame: 1 week after enrollment
using the Transcranial parenchymal color Doppler ultrasound (TCS) to trace the nigrostriatal echogenic area
Electromyography (EMG) tremor analysis
Time frame: 1 week after enrollment
EMG frequency
Electromyography (EMG) tremor analysis
Time frame: 1 week after enrollment
EMG amplitude (amplitude)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Xiaoxuan Liu principal investigator
Peking University Third Hospital
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, run by Peking University Third Hospital at 1 site in China.
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 1 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: finished, as of the sponsor's last update on 21 Jul 2021. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
nigrostriatal echogenic area (time frame: 1 week after enrollment). The study lists 3 primary outcomes in all. 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 21 Jul 2021.