Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295263
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-17
Brief Title:
Application of AI Technology for the Diagnosis and Treatment of Geriatric Diseases
Sponsor:
Qilu Hospital of Shandong University
Organization:
Qilu Hospital of Shandong University
Study Overview
Official Title:
Application of AI Technology for the Diagnosis and Treatment of Geriatric Diseases
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Alzheimers 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 Parkinsons 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
2 Characteristics of handwriting gait language eye movement biological samples blood urine stool saliva etc imaging EEG and other relevant markers in patients with Parkinsons 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 mlcase urine 3 mlcase stool 2 gcase saliva 3 mlcase 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 Parkinsons disease were included 100 patients with Alzheimers 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 p005
5 Quality control
1 Clinical data disease diagnosis determined by two Parkinsons 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 Parkinsons 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
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 mlcase urine 3 mlcase stool 2 gcase saliva 3 mlcase 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 Parkinsons disease were included 100 patients with Alzheimers 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 p005
5 Quality control
1 Clinical data disease diagnosis determined by two Parkinsons 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 Parkinsons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None