Precise Transcranial Magnetic Stimulation for Post-traumatic Stress Disorder
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active stimulation Participants received active transcranial magnetic stimulation for 10 consecutive days. The stimulation target is the right DLPFC, which was stimulated using the iTBS mode and treated twice a day, each treatment containing 1800 pulses. |
Device: Transcranial magnetic stimulation
Targets are sought through MRI, stimulated for 10 consecutive days
|
| Sham Comparator: Sham stimulation Participants received sham transcranial magnetic stimulation for 10 consecutive days. The stimulation target is the right DLPFC, which was stimulated using the iTBS mode and treated twice a day, each treatment containing 1800 pulses. |
Device: Transcranial magnetic stimulation
Targets are sought through MRI, stimulated for 10 consecutive days
|
Outcome Measures
Primary Outcome Measures
- Change in PCL-5 scores from baseline to 4 Weeks after the end of the 10 day treatment period [Baseline and Week 4 after the end of the 10 day treatment period]
Posttraumatic Stress Disorder Check List for DSM-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).
Secondary Outcome Measures
- Change in PCL-5 scores from baseline to the end of the 10 day treatment period [Baseline and 10 days]
Posttraumatic Stress Disorder Check List for DSM-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).
- Change in HAMD-17 scores from baseline to 4 Weeks after the end of 10 day treatment period [Baseline and Week 4 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
- Change in HAMD-17 scores from baseline to 4 Weeks after the end of 10 day treatment period [Baseline and 10 days]
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
- Change in HAMA scores from baseline to 4 Weeks after the end of 10 day treatment period [Baseline and Week 4 after the end of 10 day treatment period]
Hamilton depression 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
- Change in HAMA scores from baseline to 4 Weeks after the end of 10 day treatment period [Baseline and 10 days]
Hamilton depression 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
- Changes of resting state functional connectivity from baseline to the end of the 10 day treatment period [Baseline and 10 days]
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
- Behavioral changes from baseline to the end of the 10 day treatment period [Baseline and 10 days]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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The subject, regardless of gender, aged between 18 and 60 years, is admitted to the psychosomatic outpatient department of Xijing Hospital;
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The subject meets the diagnostic criteria of post-traumatic stress disorder in DSM-5;
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The score of Posttraumatic Stress Disorder Checklist for DSM-5 > 33；
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The subject can understand and is willing to strictly abide by the clinical trial protocol and signs the informed consent.
Exclusion Criteria:
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The subject has serious physical diseases or diseases that may affect the central nervous system (such as tumor, syphilis, etc.);
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The subject had previous brain diseases, head trauma, alcoholism, EEG abnormalities, MRI evidence of abnormal brain structure, or family history of epilepsy;
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The subject has contraindications to MRI scanning or transcranial magnetic stimulation treatment, such as metal or electronic instruments (intracranial metal foreign bodies, cochlear implants, cardiac pacemakers, stents and other metal foreign bodies) and space phobia;
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The subject has a history of contact with psychoactive substances or other mental diseases;
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Those at high risk of suicide, or those who have committed suicide or serious self injury and need emergency intervention;
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Pregnant, breastfeeding or planning pregnancy during the trial;
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In the judgment of the investigator, the subject has other conditions that are not suitable for the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | XIJING Hospital | Xi'an | Shaanxi | China | 710000 |
Sponsors and Collaborators
- Xijing Hospital
Investigators
- Principal Investigator: Huaning Wang, Xijing Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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. Review.
- 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. Review.
- 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.
- 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.
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