Application of AI Technology for the Diagnosis and Treatment of Geriatric Diseases
- Conditions
- Parkinson DiseaseNervous System DiseasesAlzheimer DiseaseGeriatric Diseases
- Interventions
- Other: Handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers
- Registration Number
- NCT06295263
- Lead Sponsor
- Qilu Hospital of Shandong University
- Brief Summary
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.
- Detailed Description
1. Study variables (factors) and measurements
1. 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.
2. 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.
1. Motor symptom assessment: UPDRS score
2. 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
1. Clinical data disease diagnosis: determined by two Parkinson's and movement disorders group deputy chief physicians and above;
2. Scale assessment: adjudicated by two scale-trained neurologists;
3. Statistics: performed by clinical statisticians. 6. Research feasibility analysis Qilu Hospital of Shandong University is a one-stop diagnosis and treatment center for Parkinson's disease and a clinical research center of geriatrics in Shandong Province, with a large patient attendance group and clear clinical significance; our research center is equipped with handwriting analyzer, gait analyzer, speech and eye movement capture analyzer, and has analyzers for collecting biological samples, imaging information and EEG information, which has the basis for further in-depth research.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 460
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Alzheimer Disease group Handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers 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. Healthy Adults Group Handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers 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. Parkinson Disease group Handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers 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. Nervous System Diseases group Handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers 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. Healthy geriatric group Handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers 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.
- Primary Outcome Measures
Name Time Method speech 2022-2~2026-6 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.
biological samples (blood, urine, stool, saliva, etc.) 2022-2~2026-6 3-5ml of biological specimens were retained for testing and data analysis
Handwriting 2022-2~2026-6 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.
eye movements 2022-2~2026-6 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.
images 2022-2~2026-6 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.
other relevant markers 2022-2~2026-6 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.
gait 2022-2~2026-6 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.
EEG 2022-2~2026-6 Mean frequency, relative power, absolute power, electrode correlation, coherence, time-frequency analysis，etc
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China