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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • "personalized" rTMS+drug treatment Device
    Other Names: P rTMS
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: "personalized" rTMS+drug treatment
    Description: Received "personalized" rTMS treatment 15 times for 15 days;Take paroxetine for 2 weeks
  • Traditional rTMS +drug treatment Device
    Other Names: T rTMS
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Traditional rTMS +drug treatment
    Description: Received traditional rTMS treatment 15 times for 15 days;Take paroxetine for 2 weeks

Outcomes

Type Measure Time Frame Safety Issue
Primary response rate Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment
Secondary Neuropsychological tests results of SAS Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment
Secondary Neuropsychological tests results of ADLs Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment

Sponsors