Precise Transcranial Magnetic Stimulation for Post-traumatic Stress Disorder

January 8, 2024 updated by: Xijing Hospital

Study on the Effect and Mechanism of Individualized and Precise Location Transcranial Magnetic Stimulation Based on Magnetic Resonance Imaging on Post-traumatic Stress Disorder

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active stimulation group
Participants receive active transcranial magnetic stimulation.
Device: Active transcranial magnetic stimulation
The coil parallel to the scalp is placed on the target for real and effective stimulation.
Sham Comparator: Sham stimulation group
Participants receive sham transcranial magnetic stimulation.
Device: Sham transcranial magnetic stimulation
The coil is placed perpendicular to the scalp above the target for ineffective stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 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).
Baseline and Week 4 after the end of the 10 day treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of resting state functional connectivity from baseline to the end of the 10 day treatment period
Time Frame: 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
Baseline and 10 days
Behavioral changes from baseline to the end of the 10 day treatment period
Time Frame: 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.
Baseline and 10 days
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
Time Frame: 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).
Baseline and 10 days
Change in Hamilton Depression Scale scores from baseline to 4 Weeks after the end of 10 day treatment period
Time Frame: 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.
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
Time Frame: 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.
Baseline and 10 days
Change in Hamilton Anxiety Scale scores from baseline to 4 Weeks after the end of 10 day treatment period
Time Frame: 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.
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
Time Frame: 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.
Baseline and 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Principal Investigator: Huaning Wang, Xijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 14, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20222176-F-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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