Post-stroke Depression
Conditions
Keywords
Repetitive transcranial magnetic stimulation
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.
Interventions
DEVICEpersonalized rTMS+drug treatment
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.
DEVICETraditional rTMS +drug treatment
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.
Sponsors
Zhujiang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Care Provider, Investigator, Outcomes Assessor
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
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
1. Aphasia or severe cognitive impairment, severe hearing impairment; 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactWen Wu, M.D
Outcome results
None listed