Ignite Creation Date:
2024-05-06 @ 10:25 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03256305
Status:
UNKNOWN
Last Update Posted:
2018-03-19
First Post:
2017-07-18
Brief Title:
A Study of rTMS Personalized Precision Treatment of Post-stroke Depression
Sponsor:
Zhujiang Hospital
Organization:
Zhujiang Hospital
Study Overview
Official Title:
A Clinical Control Study of rTMS Personalized Precision Treatment of Post-stroke Depression Based on Mechanism of Emotional Circuit Imbalance
Status:
UNKNOWN
Status Verified Date:
2017-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 ratio to receive Personalized rTMS treatment or traditional rTMS treatment in addition to routine antidepressant treatmentsThe data of neuropsychological tests and MRI will be collected at 0 24 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 11 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 treatmentBased 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 ADLsself-rating anxiety scaleSAS 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
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 treatmentBased 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 ADLsself-rating anxiety scaleSAS 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None