Clinical trial NCT05544110: Precise Transcranial Magnetic Stimulation for Post-traumatic Stress Disorder
Official title: Study on the Effect and Mechanism of Individualized and Precise Location Transcranial Magnetic Stimulation Based on Magnetic Resonance Imaging on Post-traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Keywords: Transcranial magnetic stimulation
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.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.

Eligibility criteria: Inclusion Criteria:

* The subject, regardless of gender, aged between 18 and 65 years, is admitted to the psychosomatic outpatient department of the First Affiliated Hospital of Air Force Medical University;
* The subject meets the diagnostic criteria of post-traumatic stress disorder in Diagnostic and Statistical Manual of Mental Disorders-5;
* The score of Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 \> 33；
* The subject can understand and is willing to strictly abide by the clinical trial protocol and signs the informed consent.

Exclusion Criteria:

* The subject has serious physical diseases or diseases that may affect the central nervous system (such as tumor, syphilis, etc.);
* Patients with PTSD who keep stable on their original medication/psychotherapy for more than 3 weeks before the start of the study or who have not taken the relevant therapeutic medication for more than 2 weeks before the start of the study will be included.Otherwise they will be excluded;
* The subject had previous brain diseases, head trauma, alcoholism, EEG abnormalities, MRI evidence of abnormal brain structure, or family history of epilepsy;
* 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;
* The subject has a history of contact with psychoactive substances or other mental diseases;
* Those at high risk of suicide, or those who have committed suicide or serious self injury and need emergency intervention;
* Pregnant, breastfeeding or planning pregnancy during the trial;
* In the judgment of the investigator, the subject has other conditions that are not suitable for the study.

Primary outcomes:
measure: 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
timeFrame: Baseline and Week 4 after the end of the 10 day treatment period
Secondary outcomes:
measure: 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
timeFrame: Baseline and 10 days
measure: Change in Hamilton Depression Scale scores from baseline to 4 Weeks after the end of 10 day treatment period
timeFrame: Baseline and Week 4 after the end of 10 day treatment period
measure: Change in Hamilton Depression Scale（HAMD-17）scores from baseline to the end of 10 day treatment period
timeFrame: Baseline and 10 days
measure: Change in Hamilton Anxiety Scale scores from baseline to 4 Weeks after the end of 10 day treatment period
timeFrame: Baseline and Week 4 after the end of 10 day treatment period
measure: Change in Hamilton Anxiety Scale scores from baseline to the end of 10 day treatment period
timeFrame: Baseline and 10 days
measure: Changes of resting state functional connectivity from baseline to the end of the 10 day treatment period
timeFrame: Baseline and 10 days
measure: Behavioral changes from baseline to the end of the 10 day treatment period
timeFrame: Baseline and 10 days
Other outcomes:
Locations:
city: Xi'an
country: China
facility: XIJING Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Huaning Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.