Precise Transcranial Magnetic Stimulation for Post-traumatic Stress Disorder

Not Applicable

Recruiting

• Conditions: PTSD

• Registration Number: NCT05544110
• Lead Sponsor: Xijing Hospital

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.

Study Timeline

• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-16
• Status Verified: 2023-02
• Study Start: 2023-02-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-11
• Primary Completion: 2024-12-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	Baseline and Week 4 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).

Secondary Outcome Measures

Name	Time	Method
Change in Hamilton Depression Scale（HAMD-17）scores from baseline to 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.Possible scores range from 0 to 52 and the higher the score, the worse the symptom.
Change in Hamilton Anxiety Scale 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 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.
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.
Change in Hamilton Anxiety Scale scores from baseline to the end of 10 day treatment period	Baseline and 10 days	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.
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	Baseline and 10 days	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).
Change in Hamilton Depression Scale 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.Possible scores range from 0 to 52 and the higher the score, the worse the symptom.

Trial Locations

Locations (1)

XIJING Hospital; 🇨🇳 Xi'an, Shaanxi, China