Evaluation of Response to a Course of Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder Using Vocal Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- GCS CIPS
- 入组人数
- 156
- 试验地点
- 9
- 主要终点
- Area under the curve of the model predicting response to rTMS treatment
研究概览
简要总结
Voice recordings taken prior to the start of repetitive transcranial magnetic stimulation (rTMS) therapy will be used to develop a predictive model of treatment response using machine learning for patients with major depressive disorders (MDD).
详细描述
The objective of this study is to investigate whether voice biomarkers taken prior to the start of rTMS can predict the response to a 30-session course of rTMS in patients with MDD with good sensitivity and specificity. Patients who are prescribed rTMS to treat an episode of MDD at one of the nine participating centres will be invited to participate in the study. The protocol includes one inclusion visit and seven evaluation visits before, during, and after the course of rTMS. The rTMS course will last for six weeks, comprising of 30 sessions with five sessions per week. Prior to the commencement of the rTMS course, patients will need to complete several questionnaires. Before the first session, voice tests will be recorded using the Callyope application. Patients will answer questionnaires and assess voice tests weekly and after the final rTMS session to track the progression of depressive symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having a prescription for a course of rTMS to treat an episod of MDD
- •Unipolar MDD confirmed according to DSM-5 criteria
- •Moderate to severe MDD (MADRS score > 19)
- •No use of psychotropic medication or use stabilised (no change in dose < 4 weeks before study entry)
- •Able to understand, speak, read and write French
- •Express informed consent, after a period of reflection
- •Affiliated with a French social security scheme or beneficiary of such a scheme
排除标准
- •History of epilepsy or convulsive seizures
- •Previous brain surgery
- •History of recent cranial trauma (< 6 months)
- •Presence of severe suicidal ideation
- •Psychotic disorders
- •Metal objects in the head, eyes or brain
- •Implanted ferromagnetic equipment (pace maker, cochlear implant, etc.)
- •Clinical evidence of serious or uncontrolled alcohol or substance use disorders in the three months prior to the study
- •Active withdrawal from alcohol or other substances
- •One or more recent rTMS sessions (< 4 weeks)
- •Other non-drug therapy recently initiated (< 4 weeks) to treat EDC (psychotherapy, phototherapy, vagus nerve stimulation, etc.)
- •Pathology altering phonation based on the perception of the investigator
- •Subjects in a period of relative exclusion from another protocol
- •Adults protected by law or patients under guardianship or curatorship
- •Subjects deprived of their liberty by judicial or administrative decision
- •Pregnant or breast-feeding women
结局指标
主要结局
Area under the curve of the model predicting response to rTMS treatment
时间窗: 6 weeks : before the first session of rTMS (vocal samples) and before and after the rTMS treatment (MADRS score)
Area under the curve of the model predicting response to rTMS treatment, objectified by a 50% reduction in MADRS depression score, trained from vocal biomarkers recorded before rTMS treatment.
次要结局
- Risk and coverage of the different prediction models obtained.(6 weeks : After rTMS treatment)
- Area under the curve of the rTMS remission prediction model(6 weeks : before the first session of rTMS (vocal samples) and before and after the rTMS treatment (MADRS score))
- Area under the curve of the prediction model of the response to the rTMS course, trained with the addition of weekly recorded voice samples.(6 weeks : weekly)
- Area under the curve of the different prediction models obtained, starting from pre-trained models on healthy subject databases.(6 weeks : Before and after rTMS treatment)
- Area under the curve of the prediction model of the self-assessed response to the rTMS course(6 weeks : before the first session of rTMS (vocal samples) and each week during the rTMS treatment (PHQ-9 score))
- Comparison of the prediction models obtained with or without the use of advanced data encryption algorithms.(6 weeks : After rTMS treatment)
- Area under the curve of the model predicting the response to rTMS treatment, trained with the addition of clinical indicators(6 weeks : before the first session of rTMS (vocal samples) and before and after or weekly (clinical indicators))
- Comparison between the scores predicted by the model and the actual scores obtained on the different questionnaires assessed.(6 weeks : before the first session of rTMS (vocal samples) and before and after the treatment (questionnaires))