A Study of rTMS Personalized Precision Treatment of Post-stroke Depression
- Conditions
- Post-stroke Depression
- Interventions
- Device: "personalized" rTMS+drug treatmentDevice: Traditional rTMS +drug treatment
- Registration Number
- NCT03256305
- Lead Sponsor
- Zhujiang Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description "personalized" rTMS+drug treatment "personalized" rTMS+drug treatment Received "personalized" rTMS treatment 15 times for 15 days;Take paroxetine for 2 weeks Traditional rTMS +drug treatment Traditional rTMS +drug treatment Received traditional rTMS treatment 15 times for 15 days;Take paroxetine for 2 weeks
- Primary Outcome Measures
Name Time Method response rate Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment 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.
- Secondary Outcome Measures
Name Time Method Neuropsychological tests results of SAS Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment 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.
Neuropsychological tests results of ADLs Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment 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.
Trial Locations
- Locations (1)
Zhujiang hospital
🇨🇳Guangzhou, Guangdong, China