The purpose of this study is to investigate the efficacy and safety of repetitive transcranial magnetic stimulation under precise localization for post-traumatic stress disorder
Participants who meet the entry conditions and sign the informed consent will be divided into two groups. The stimulation target of each participant will be determined according to MRI. The test group will receive active transcranial magnetic stimulation for 10 consecutive days, and the control group will receive sham stimulation. Symptom severity is assessed by scales and audio and video recordings at baseline, during treatment period and follow-up.Blood samples will also be collected from patients prior to treatment and will be analyzed histologically to explore differences in response to the intervention and biological mechanisms in different subgroups of patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
The coil parallel to the scalp is placed on the target for real and effective stimulation.
The coil is placed perpendicular to the scalp above the target for ineffective stimulation.
XIJING Hospital
Xi'an, Shaanxi, China
RECRUITINGChange in Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5 scores from baseline to 4 Weeks after the end of the 10 day treatment period
Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5(PCL-5) is a validated, self-reported instrument assessing PTSD symptom severity over the past week or month period .Possible scores range from 0 to 80 . Change = (Week 4 Score -Baseline Score).
Time frame: Baseline and Week 4 after the end of the 10 day treatment period
Change in Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5 scores scores from baseline to the end of the 10 day treatment period
Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5(PCL-5)is a validated, self-reported instrument assessing PTSD symptom severity over the past week or month period .Possible scores range from 0 to 80 . Change = (End Score -Baseline Score).
Time frame: Baseline and 10 days
Change in Hamilton Depression Scale scores from baseline to 4 Weeks after the end of 10 day treatment period
Hamilton Depression Scale(HAMD-17) is a commonly used clinical evaluation standard for the severity of depressive symptoms. There are 17 items in total, which can be scored before and after treatment to evaluate the severity of the disease and the treatment effect.Possible scores range from 0 to 52 and the higher the score, the worse the symptom.
Time frame: Baseline and Week 4 after the end of 10 day treatment period
Change in Hamilton Depression Scale(HAMD-17)scores from baseline to the end of 10 day treatment period
Hamilton Depression Scale(HAMD-17) is a commonly used clinical evaluation standard for the severity of depressive symptoms. There are 17 items in total, which can be scored before and after treatment to evaluate the severity of the disease and the treatment effect.Possible scores range from 0 to 52 and the higher the score, the worse the symptom.
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Time frame: Baseline and 10 days
Change in Hamilton Anxiety Scale scores from baseline to 4 Weeks after the end of 10 day treatment period
Hamilton Anxiety Scale(HAMA) is suitable for assessing the severity of anxiety symptoms. It has 14 items and adopts a 5-level scoring method of 0-4 points.Possible scores range from 0 to 56 and the higher the score, the worse the symptom.
Time frame: Baseline and Week 4 after the end of 10 day treatment period
Change in Hamilton Anxiety Scale scores from baseline to the end of 10 day treatment period
Hamilton Anxiety Scale(HAMA) is suitable for assessing the severity of anxiety symptoms. It has 14 items and adopts a 5-level scoring method of 0-4 points.Possible scores range from 0 to 56 and the higher the score, the worse the symptom.
Time frame: Baseline and 10 days
Changes of resting state functional connectivity from baseline to the end of the 10 day treatment period
Before and after treatment, MRI is performed for each patient to measure the blood oxygen level of each brain region, from which the functional connectivity between brain regions could be statistically obtained, and then the differences of the functional connectivity before and after treatment are compared
Time frame: Baseline and 10 days
Behavioral changes from baseline to the end of the 10 day treatment period
PTSD structured interviews will be conducted with participants at baseline and after the treatment. At the same time, audio and video recordings will be made, and data such as expression, language and body movements will extracted for comparison before and after treatment.
Time frame: Baseline and 10 days