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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active stimulation group | Experimental | Participants receive active transcranial magnetic stimulation. |
|
| Sham stimulation group | Sham Comparator | Participants receive sham transcranial magnetic stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active transcranial magnetic stimulation | Device | The coil parallel to the scalp is placed on the target for real and effective stimulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change 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). | Baseline and Week 4 after the end of the 10 day treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yaochi Zhang | Contact | 86-18294037117 | a18294037117@163.com | |
| Yuyu Zhang | Contact | 86-15535849017 | 782861599@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Huaning Wang | Xijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| XIJING Hospital | Recruiting | Xi'an | Shaanxi | 710000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31230462 | Background | Philip NS, Barredo J, Aiken E, Larson V, Jones RN, Shea MT, Greenberg BD, van 't Wout-Frank M. Theta-Burst Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder. Am J Psychiatry. 2019 Nov 1;176(11):939-948. doi: 10.1176/appi.ajp.2019.18101160. Epub 2019 Jun 24. | |
| 32252538 | Background | Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020 Aug 1;177(8):716-726. doi: 10.1176/appi.ajp.2019.19070720. Epub 2020 Apr 7. |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Sham transcranial magnetic stimulation | Device | The coil is placed perpendicular to the scalp above the target for ineffective stimulation. |
|
| 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. | 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. | 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. | 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. | 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 | 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. | Baseline and 10 days |
| 26918313 | Background | Koch SB, van Zuiden M, Nawijn L, Frijling JL, Veltman DJ, Olff M. ABERRANT RESTING-STATE BRAIN ACTIVITY IN POSTTRAUMATIC STRESS DISORDER: A META-ANALYSIS AND SYSTEMATIC REVIEW. Depress Anxiety. 2016 Jul;33(7):592-605. doi: 10.1002/da.22478. Epub 2016 Feb 25. |
| 29246436 | Background | Raij T, Nummenmaa A, Marin MF, Porter D, Furtak S, Setsompop K, Milad MR. Prefrontal Cortex Stimulation Enhances Fear Extinction Memory in Humans. Biol Psychiatry. 2018 Jul 15;84(2):129-137. doi: 10.1016/j.biopsych.2017.10.022. Epub 2017 Nov 6. |
| 30054570 | Background | Fenster RJ, Lebois LAM, Ressler KJ, Suh J. Brain circuit dysfunction in post-traumatic stress disorder: from mouse to man. Nat Rev Neurosci. 2018 Sep;19(9):535-551. doi: 10.1038/s41583-018-0039-7. |
| 38960463 | Derived | Zhang Y, Peng Z, Tang N, Zhang Y, Liu N, Lv R, Meng Y, Cai M, Wang H. Efficacy of MRI-guided rTMS for post-traumatic stress disorder by modulating amygdala activity: study protocol for a randomised controlled trial. BMJ Open. 2024 Jul 3;14(7):e081751. doi: 10.1136/bmjopen-2023-081751. |