Precise Transcranial Magnetic Stimulation for Post-traumatic Stress Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-06-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active stimulation group

Participants receive active transcranial magnetic stimulation.

Group Type EXPERIMENTAL

Active transcranial magnetic stimulation

Intervention Type DEVICE

The coil parallel to the scalp is placed on the target for real and effective stimulation.

Sham stimulation group

Participants receive sham transcranial magnetic stimulation.

Group Type SHAM_COMPARATOR

Sham transcranial magnetic stimulation

Intervention Type DEVICE

The coil is placed perpendicular to the scalp above the target for ineffective stimulation.

Interventions

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Active transcranial magnetic stimulation

The coil parallel to the scalp is placed on the target for real and effective stimulation.

Intervention Type DEVICE

Sham transcranial magnetic stimulation

The coil is placed perpendicular to the scalp above the target for ineffective stimulation.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No