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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

China1 site
  • Peking University Third Hospital

    Beijing

Other trials in China

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.

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 groups in NCT04970745
Study groupRoleWhat they receive
high-riskAfter 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
riskAfter 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-riskAfter 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.

  1. nigrostriatal echogenic area

    using the Transcranial parenchymal color Doppler ultrasound (TCS) to trace the nigrostriatal echogenic area

    Measured: 1 week after enrollment

  2. Electromyography (EMG) tremor analysis

    EMG frequency

    Measured: 1 week after enrollment

  3. 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.

  1. First posted21 Jul 2021
  2. Study start1 Jan 2018
  3. Primary completion30 Jun 2019
  4. Study completion1 Aug 2019

Resources

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)
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

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.

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