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临床试验/NCT04685083
NCT04685083Unknown不适用

Research on Voice Intelligent Monitoring Technology for Early Warning of Recurrence of Depression Disorder

Shanghai Mental Health Center1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2020年12月31日最近更新:
适应症

试验速览

阶段
不适用
入组人数
240
试验地点
1
主要终点
Neural activity parameters of EEG

研究概览

简要总结

This study aims to collect the voice output of depression patients and healthy subjects, extract the acoustic and semantic parameters, compare the similarities and differences between the depression group and the healthy control group horizontally, and track the depression patients' changes in the rehabilitation stage to construct a voice-based early warning model of depression recurrence. At the same time, the use of EEG technology, nuclear magnetic resonance and near-infrared brain imaging technology to record and analyze the neural activity characteristics behind the voice variation of depression patients, and build a neural mechanism model. And construct the facial recognition function through the convolutional neural network, extract the facial parameters to enrich the intelligent monitoring and early warning technology.

  1. Collect linguistic data of depression patients and healthy people collected in the laboratory, as well as data related to changes in the condition of depression patients in daily life and home care after treatment, and construct comparative data and dynamic observations Large database to analyze its voice mutation characteristics;
  2. Using EEG technology, nuclear magnetic resonance, and near-infrared brain imaging to record and analyze the neural activity characteristics behind the voice variation of depression patients, and build a neural mechanism model.
  3. Use the convolutional neural network to realize the facial recognition function, and extract the facial parameters to enrich the monitoring indicators.
  4. Based on the dynamic observation big data of depression speech mutation, construct the speech feature parameter vector of depression recurrence, and use adaptive personalized intelligent learning algorithm to develop intelligent monitoring and early warning technology.
  5. Establish monitoring and diagnostic indicators for recurrence early warning, verify the application of the above-mentioned intelligent monitoring and early warning technology in rehabilitation guidance, and make a comprehensive assessment.

详细描述

Case control study Clinical symptoms, speech behavior test, EEG data, near-infrared brain imaging data and facial expression data are collected from three groups of subjects (consolidation/maintenance depression patient group, acute episode depression patient group and healthy alternatives), In terms of magnetic resonance data and other aspects, compare the similarities and differences of the data of the three groups of subjects.

Follow up research The acute-onset patient group will receive follow-up every two weeks for three months, and then continue in June, September, December, 18 and 24 months. Consolidation/maintenance patients and healthy patients will receive follow-up evaluations in March, June, September, December, 18 and 24 months after enrollment. The content includes clinical symptom assessment, behavioral testing, EEG testing, near infrared testing, etc. The time points of cranial imaging detection are 0, March, December and 24 months. In the laboratory, if the subject agrees to collect language information in the patient's real life environment.

Evaluation and inspection items

  1. Clinical scale evaluation
  2. Speech Behavior Test Using speech production paradigm, semantic feature task, emotional prosody perception paradigm and emotional vocabulary paradigm to comprehensively detect the language perception, comprehension and output of patients with depression to find objective indicators of speech mutation. Voice detection includes short-term energy (Max, Min, Mean), pitch (Max, Min, Mean), voice speed, number of voice interruptions, short-term zero-crossing rate (Max, Min, Mean), first formant, first Two formants, 12-order MFCC (12 coefficients) and other parameters. The experiment is carried out in a well-lit and quiet room. Before the experiment, the subject will explain the experiment process to the subjects. After the experiment, in order to avoid interference, the subject should leave the room. The whole process of the experiment was in the same computer program, and the subjects responded according to the task requirements on the screen.

2.1 Speech and video production paradigm The speech and video output paradigm used in this study includes five tasks: interview, short text reading, recitation, picture description and video viewing. The video viewing task is only used for facial video data collection. The experiment is written and run using E-prime 2.0 software. Participants completed five speech production tasks accordingly, and recorded their voices and facial expressions throughout the experiment to obtain speech and video data.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with depression in the consolidation/maintenance phase
  • 18-65 years old, no gender limit;
  • Meet the DSM-5 diagnostic criteria for depression;
  • Currently in the consolidation/maintenance phase, with stable condition, HAMD-17 <7 points;
  • Patients and their guardians understand the nature of this study and sign an informed consent form.
  • Have sufficient audiovisual level to complete the necessary inspections for research;
  • Han nationality
  • Willing to participate in this research;
  • Education level is junior high school and above.
  • Patients with depression in acute onset:
  • 18-65 years old, no gender limit;
  • Meet the DSM-5 diagnostic criteria for depression;
  • Currently in depressive episode, HAMD-17>17 points;
  • Patients and their guardians understand the nature of this study and sign an informed consent form.
  • Have sufficient audiovisual level to complete the necessary inspections for research;
  • Han nationality
  • Willing to participate in this research;
  • Education level is junior high school and above.
  • Healthy control subjects
  • 18-65 years old, no gender limit;
  • Depressive symptoms have never occurred, and it does not meet the DSM-5 diagnostic criteria for depression or other mental disorders;
  • No history of taking psychiatric drugs;
  • Have sufficient audiovisual level to complete the necessary inspections for research;
  • Willing to participate in this research;
  • Education level is junior high school and above.

排除标准

  • Patients with depression in the consolidation/maintenance phase
  • Patients with severe brain diseases and other severe physical diseases;
  • Diagnosis of other mental diseases such as schizophrenia and bipolar disorder;
  • There are negative beliefs or a higher risk of suicide;
  • People who are addicted to psychoactive substances such as alcohol or drugs;
  • Women who are pregnant or about to become pregnant recently, and women who are breastfeeding;
  • There are metal implants in the body: there is a pacemaker, intracranial silver clip, metal denture, arterial stent, arterial clip, joint metal fixation, or other metal implant conditions, or non-right-handed (this standard (Only for MRI testers);
  • Failure to sign or refuse to sign the informed consent form.
  • Patients with depression in acute onset:
  • Patients with severe brain diseases and other severe physical diseases;
  • Diagnosis of other mental diseases such as schizophrenia and bipolar disorder;
  • There are negative beliefs or a higher risk of suicide;
  • People who are addicted to psychoactive substances such as alcohol or drugs;
  • Women who are pregnant or about to become pregnant recently, and women who are breastfeeding;
  • There are metal implants in the body: there is a pacemaker, intracranial silver clip, metal denture, arterial stent, arterial clip, joint metal fixation, or other metal implant conditions, or non-right-handed (this standard (Only for MRI testers);
  • Failure to sign or refuse to sign the informed consent form.
  • Healthy control subjects:
  • Two lines and three generations of mental illness history;
  • There are negative beliefs or a higher risk of suicide;
  • Serious brain diseases and other severe physical diseases;
  • Pregnant and lactating women;
  • History of exposure to psychoactive substances such as alcohol or drugs;
  • Failure to sign or refuse to sign the informed consent form.
  • There is a metal implant in the body: there is a pacemaker, intracranial silver clip, metal denture, arterial stent, arterial clip, joint metal fixation, or other metal implant conditions, etc. (this standard is limited to MRI testers ).

结局指标

主要结局

Neural activity parameters of EEG

时间窗: 2022.6

Neural activity parameters of depression patients and healthy subjects are extracted through EEG technology.

Neural activity parameters of MRI

时间窗: 2022.6

Neural activity parameters of depression patients and healthy subjects are extracted through MRI.

Acoustic parameters

时间窗: 2022.6

Acoustic parameters of depression patients and healthy subjects are extracted through voice recording.

Facial action parameters of facial expression recognition technology

时间窗: 2022.6

The facial expression recognition technology is implemented by convolutional neural network to extract facial action parameters.

Neural activity parameters of near-infrared brain imaging

时间窗: 2022.6

Neural activity parameters of depression patients and healthy subjects are extracted through near-infrared brain imaging.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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