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| Name | Class |
|---|---|
| Shandong University | OTHER |
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1) Characteristics of handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers in patients with Alzheimer's disease.
(2) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), imaging, EEG, and other relevant markers in patients with Parkinson's disease.
(3) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers in patients with other neurological disorders.
(4) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), images, EEG and other relevant markers in elderly patients.
1. Study variables (factors) and measurements
All enrolled subjects collected data including general clinical information, PD patients completed motor function assessment and non-motor function assessment, AD patients completed cognitive function assessment and mood-sleep assessment, patients with other neurological disorders perfected disease-related clinical information and scale assessment, and healthy elderly and young controls perfected general clinical information and scale screening.
All selected subjects complete handwriting recording, gait assessment, language entry and eye movement recording, and collect biological samples (blood (3 ml/case), urine (3 ml/case), stool (2 g/case), saliva (3 ml/case) and other clinical test results), imaging, EEG and other relevant markers for the study of diagnostic and treatment plan and correlation analysis of AI technology.
Motor symptom assessment: UPDRS score
Non-motor symptom assessment: Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MOCA), Hamilton Anxiety Scale (HAMD), and Hamilton Anxiety Diagnostic Scale (HAD). Hamilton Anxiety Scale (HAMD), Hamilton Depression Scale (HDMD), SF-36.
2. Sample size 100 patients with primary Parkinson's disease were included, 100 patients with Alzheimer's disease were included, 100 patients with other neurological disorders were included, 80 healthy elderly controls, and 80 healthy young controls.
3 Data collection and management Data collection was firstly collected by applying the paper version of the case report form, and then entered into the computer by a specialized person.
4. Statistical analysis methods For continuous variables, statistical descriptions were performed using mean ± standard deviation, and for categorical variables, frequency and rate (%) were used. For comparison of parameters between two groups, t-test or rank sum test was used for continuous type variables and chi-square test was used for categorical variables. For one-way correlation analysis, Pearson or Spearman correlation analysis was used. For multifactor analysis, generalized linear model or logistic regression model was used. All of the above parameters were considered statistically significant at p<0.05.
5. Quality control
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson Disease group | 100 patients with primary Parkinson's disease were included, mainly from outpatient clinics and wards of the Parkinson's Disease and Movement Disorders Center. Inclusion criteria: patients with primary Parkinson's disease, based on the 2015 MDS Parkinson's disease diagnostic criteria. Exclusion criteria: ① patients suffering from other central nervous system diseases, such as cerebrovascular disease, traumatic brain injury, central system inflammatory diseases, intracranial tumors and postoperative neurosurgery; ② patients with various types of cognitive disorders (MMSE score <24); ③ severe psychiatric disorders that are difficult to cooperate. |
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| Alzheimer Disease group | One hundred patients with Alzheimer's disease were included, mainly from geriatric neurology outpatient clinics and wards (F5A & F6A). Inclusion criteria: patients with Alzheimer's disease, meeting the IWG-2 clinical diagnostic criteria as the basis. Exclusion criteria: ① patients suffering from other central nervous system diseases, such as cerebrovascular disease, traumatic brain injury, central system inflammatory diseases, intracranial tumors and postoperative neurosurgery; ② severe psychiatric illnesses that are difficult to cooperate with. |
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| Nervous System Diseases group | Neurodegenerative diseases (non-PD non-AD) group 100: source neurology outpatient clinic visits, exclusion criteria: ① patients suffering from other central nervous system diseases, such as cerebrovascular disease, traumatic brain injury, central system inflammatory diseases, intracranial tumors and neurosurgery postoperative; ② severe psychiatric diseases difficult to cooperate with the person. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers | Other | Handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers in all experimental and control groups |
| Measure | Description | Time Frame |
|---|---|---|
| Handwriting | The patterns and related auxiliary features of patients' handwritten notes were analyzed,the specific indicators used should be adjusted according to the results of artificial intelligence calculation, and the unit should be adjusted according to the indicators used. | 2022-2~2026-6 |
| gait | The patients' stride length and gait frequency were analyzed,the specific indicators used should be adjusted according to the results of artificial intelligence calculation, and the unit should be adjusted according to the indicators used. | 2022-2~2026-6 |
| speech | The speech of the patients were collected and analyzed,the specific indicators used should be adjusted according to the results of artificial intelligence calculation, and the unit should be adjusted according to the indicators used. | 2022-2~2026-6 |
| eye movements | The eye movement data of the patients were collected and analyzed,the specific indicators used should be adjusted according to the results of artificial intelligence calculation, and the unit should be adjusted according to the indicators used. | 2022-2~2026-6 |
| biological samples (blood, urine, stool, saliva, etc.) | 3-5ml of biological specimens were retained for testing and data analysis | 2022-2~2026-6 |
| images | MRI、MRA、SWI、DTI and other imaging data were analyzed,the specific indicators used should be adjusted according to the results of artificial intelligence calculation, and the unit should be adjusted according to the indicators used. |
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Inclusion Criteria 1.1 A total of 100 patients with primary Parkinson's disease were enrolled. The inclusion criteria were as follows: patients with primary Parkinson's disease, based on the 2015 MDS diagnostic criteria for Parkinson's disease. Disorder (MMSE score < 24); (3) those with severe mental illness who are difficult to cooperate.
1.2 A total of 100 patients with Alzheimer's disease were enrolled. The inclusion criteria were as follows: patients with Alzheimer's disease, based on the IWG-2 clinical diagnostic criteria.
1.3 Neurodegenerative diseases (non-PD and non-AD) group (n = 100) : meeting the diagnostic criteria of the corresponding diseases.
1.4 Eighty healthy elderly controls were included. The inclusion criteria were as follows: ① voluntarily participated in this study and signed the informed consent; ② Age and gender were matched with the case group.
1.5 80 young healthy controls, inclusion criteria: ① voluntarily participated in this study and signed the informed consent; ② Gender was matched with the case group, and the age was less than 60 years old.
Exclusion Criteria 2.1 A total of 100 patients with PD were enrolled. Exclusion criteria: ① patients with other central nervous system diseases, such as cerebrovascular diseases, brain trauma, inflammatory diseases of the central system, intracranial tumors and after neurosurgery; ② patients with various types of cognitive impairment (MMSE score < 24); (3) those with severe mental illness who are difficult to cooperate.
2.2 A total of 100 patients with Alzheimer's disease were enrolled. The exclusion criteria were: ① patients with other central nervous system diseases, such as cerebrovascular diseases, brain trauma, central system inflammatory diseases, intracranial tumors and after neurosurgery; ② patients with severe mental illness who are difficult to cooperate.
2.3 Neurodegenerative diseases (non-PD non-AD) group (n = 100), exclusion criteria: ① patients with other central nervous system diseases, such as cerebrovascular diseases, brain trauma, central system inflammatory diseases, intracranial tumors and after neurosurgery; ② patients with severe mental illness who are difficult to cooperate.
2.4 Eighty healthy elderly controls were included. The exclusion criteria were as follows: ① History of chronic diseases related to the study subjects, such as cerebrovascular diseases, brain trauma, inflammatory diseases of the central system, intracranial tumors and neurosurgery; ② patients with various types of cognitive impairment (MMSE score < 24); ③ Poor compliance.
2.5 80 young healthy controls, exclusion criteria: ① history of chronic diseases related to the study subjects, such as cerebrovascular diseases, brain trauma, inflammatory diseases of the central system, intracranial tumors and neurosurgical surgery; ② patients with various types of cognitive impairment (MMSE score < 24); ③ Poor compliance.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Ma | Contact | 18560082039 | majun1228med@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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lood, urine, stool, saliva, etc
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| Healthy geriatric group | Healthy elderly control 80 people, from peer attendees and health checkup centers. Inclusion criteria: ① Voluntary participation in this study and signing of informed consent; ② Age and gender matched with the patients in the case group; Exclusion criteria: ① Previous history of chronic diseases related to the study subjects, such as cerebrovascular disease, traumatic brain injury, inflammatory diseases of the central system, intracranial tumors and neurosurgery, etc.; ② Patients with various types of cognitive disorders (MMSE scores <24); ③ Those with poor adherence. |
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| Healthy Adults Group | Young healthy controls 80 people, from peer attendees and health screening centers. Inclusion criteria: ① Voluntary participation in the study and signing of informed consent; ② Gender matched with the patients in the case group, age <60 years; Exclusion criteria: ① History of chronic diseases related to the study subjects, such as cerebrovascular disease, traumatic brain injury, inflammatory diseases of the central system, intracranial tumors and neurosurgery, etc.; ② With various types of cognitive disorders (MMSE scores <24); ③ Poor adherence to the study. Poor adherence. |
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| 2022-2~2026-6 |
| EEG | Mean frequency, relative power, absolute power, electrode correlation, coherence, time-frequency analysis,etc | 2022-2~2026-6 |
| other relevant markers | Some other markers are waiting to be studied and discovered,the specific indicators used should be adjusted according to the results of artificial intelligence calculation, and the unit should be adjusted according to the indicators used. | 2022-2~2026-6 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D000544 | Alzheimer Disease |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D003704 | Dementia |
| D024801 | Tauopathies |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005684 | Gait |
| D005133 | Eye Movements |
| D001800 | Blood Specimen Collection |
| D014554 | Urination |
| D003672 | Defecation |
| ID | Term |
|---|---|
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D016138 | Walking |
| D008124 | Locomotion |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D009799 | Ocular Physiological Phenomena |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D014553 | Urinary Tract Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D004068 | Digestive System Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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