A Study of rTMS Personalized Precision Treatment of Post-stroke Depression

Study Overview
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Brief Summary
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This is a multicenter, randomized trial aims to reveal the efficacy and safety of Repetitive transcranial magnetic stimulation (rTMS) individualized therapy based on the 'emotional loop destabilization' mechanism of PSD .One hundred and twenty participants will be recruited from three centers and randomized with a 1:1 ratio to receive Personalized rTMS treatment or traditional rTMS treatment in addition to routine antidepressant treatments.The data of neuropsychological tests and MRI will be collected at 0, 2，4 and 8 weeks after the commencement of the treatment.

Detailed Description
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This is a multicenter, randomized trial aims to reveal the efficacy and safety of rTMS individualized therapy based on the 'emotional loop destabilization' mechanism of PSD .One hundred and twenty participants will be recruited from three centers and randomized with a 1:1 ratio to receive Personalized rTMS treatment or traditional rTMS treatment in addition to routine antidepressant treatments. Based on inclusion and exclusion criteria, after stroke depression (post-stroke depression, PSD) cases were collected and randomized into two groups: individualized rTMS+ drug treatment group and traditional rTMS plus traditional drug treatment group. The main indicators were the effective rate of treatment.Based on inclusion and exclusion criteria, after stroke depression (post-stroke depression, PSD) cases were collected and randomized into two groups: individualized rTMS+ drug treatment group and traditional rTMS plus traditional drug treatment group. The main indicators were the effective rate of treatment. The primary outcome is the measurement of 24-item Hamilton Depression Rating Scale (HAMD-24) scores, the secondary outcomes include National Institutes of Health Stroke Scale (NIHSS), Activities of Daily Living Scale (ADLs),self-rating anxiety scale(SAS). The record of the adverse reactions and sequelae during treatment and follow-up, with a view to providing a better clinical method for the treatment of PSD.

Official Title
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A Clinical Control Study of rTMS Personalized Precision Treatment of Post-stroke Depression Based on Mechanism of Emotional Circuit Imbalance

Conditions
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Post-stroke Depression

Intervention / Treatment
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* Device: personalized rTMS+drug treatment
* Device: Traditional rTMS +drug treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria （1） First-time ischemic stroke with clinical and MRI or CT findings of basal ganglia stroke (ICD-10-CM code 293.83[F06.32]) (3) Right-handedness (4)Clear consciousness (5)Aged 25-75 years with a recent (less than 24 months) ischemic stroke; Exclusion Criteria Aphasia or severe cognitive impairment, severe hearing impairment; Contraindications of MRI scan and rTMS treatment such as pacemaker implantation; (3)Depression caused by psychoactive substances and non addictive substances;（4）Prior history of depressive disorders or major trauma within 1 year, severe depression or any other severe mental disorders; （5）Pregnant or breast-feeding women; （6）Refusal to sign informed consent of this study

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Care Provider, Investigator, Outcomes Assessor
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: personalized rTMS+drug treatment<br>Received personalized rTMS treatment 15 times for 15 days;Take paroxetine for 2 weeks | Device: personalized rTMS+drug treatment<br>* High frequency（10HZ）stimulation of brain regions corresponding to lesion, low-frequency （1HZ）stimulation of the contralateral brain, intensity=90%MT（motor thresholds). Each sequence is 20 times, duration is 10 seconds, each sequence spaced 60s, 20 sequences per day, 1 times a day ,total times is 15. Taking paroxetine 2 weeks, Take 20 mg a day.<br>* Other names: P rTMS;|
| Active Comparator: Traditional rTMS +drug treatment<br>Received traditional rTMS treatment 15 times for 15 days;Take paroxetine for 2 weeks | Device: Traditional rTMS +drug treatment<br>* Traditional rTMS treatment protocol parameters: localization of left DLPFC: frequency=10 Hz; localization of right DLPFC: frequency=1 Hz, intensity=90%MT, Each sequence is 20 times, duration is 10 seconds, each sequence spaced 60s, 20 sequences per day,1 times a day,total times is 15. Taking paroxetine 2 weeks, Take 20 mg a day.<br>* Other names: T rTMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate | Compare the HAMD-24 scores from baseline to the end of the treatment.the response to treatment is defined as at least a 30% reduction of the HAMD-24 total score with a final HAMD-24 score. The score decreased by more than 50% for the treatment of good results.The response rate is defined as the percentage of number of response. | Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological tests results of SAS | Get the change of the result of self-rating anxiety scale (SAS) by Comparing the change of SAS scores from baseline to the end of the treatment in each group. | Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment | 
| Neuropsychological tests results of ADLs | Get the change of the result of Activities of Daily Living Scale (ADLs) by Comparing the change of ADLs scores from baseline to the end of the treatment in each group. | Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Repetitive transcranial magnetic stimulation