Application of Tremor Analysis in Parkinson's Disease and Its Related Diseases

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 Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Transcranial parenchymal color Doppler ultrasound (TCS); Other: Electromyography (EMG) tremor analysis

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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
high-risk; After performing midbrain ultrasound and tremor analysis, patients with positive results of both tests are considered very high-risk patients,	Other: Transcranial parenchymal color Doppler ultrasound (TCS); tracing the nigrostriatal echogenic area; Other: Electromyography (EMG) tremor analysis; observed 1, frequency 2, amplitude (amplitude) 3, correlation between the two sides 4, load and post-drug test differences
risk; After performing midbrain ultrasound and tremor analysis, patients with positive results of 1 out of 2 tests are considered risk patients	Other: Transcranial parenchymal color Doppler ultrasound (TCS); tracing the nigrostriatal echogenic area; Other: Electromyography (EMG) tremor analysis; observed 1, frequency 2, amplitude (amplitude) 3, correlation between the two sides 4, load and post-drug test differences
low-risk; After performing midbrain ultrasound and tremor analysis, patients with negative results of both tests are considered risk patients	Other: Transcranial parenchymal color Doppler ultrasound (TCS); tracing the nigrostriatal echogenic area; Other: Electromyography (EMG) tremor analysis; observed 1, frequency 2, amplitude (amplitude) 3, correlation between the two sides 4, load and post-drug test differences

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nigrostriatal echogenic area	using the Transcranial parenchymal color Doppler ultrasound (TCS) to trace the nigrostriatal echogenic area	1 week after enrollment
Electromyography (EMG) tremor analysis	EMG frequency	1 week after enrollment
Electromyography (EMG) tremor analysis	EMG amplitude (amplitude)	1 week after enrollment

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Xiaoxuan Liu, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: M2018222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No