Precise Transcranial Magnetic Stimulation for Post-traumatic Stress Disorder

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

Conditions: PTSD

Treatments: Device: Sham transcranial magnetic stimulation; Device: Active transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05544110

KY20222176-F-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups

Active stimulation group

Experimental group

Description:

Participants receive active transcranial magnetic stimulation.

Treatment:

Device: Active transcranial magnetic stimulation

Sham stimulation group

Sham Comparator group

Description:

Participants receive sham transcranial magnetic stimulation.

Treatment:

Device: Sham transcranial magnetic stimulation