Precise Transcranial Magnetic Stimulation for Post-traumatic Stress Disorder

PTSD Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05544110
• Other study ID #: KY20222176-F-1
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2023
• Source: Xijing Hospital
• Contact: Yaochi Zhang
• Phone: 86-18294037117
• Email: a18294037117[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Device:
• Active transcranial magnetic stimulation
The coil parallel to the scalp is placed on the target for real and effective stimulation.
• Sham transcranial magnetic stimulation
The coil is placed perpendicular to the scalp above the target for ineffective stimulation.

Locations

Country	Name	City	State
China	XIJING Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	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
Secondary	Change in Hamilton Depression Scale scores from baseline to 4 Weeks 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
Secondary	Change in Hamilton Depression Scale(HAMD-17)scores from baseline to 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 10 days
Secondary	Change in Hamilton Anxiety Scale scores from baseline to 4 Weeks 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
Secondary	Change in Hamilton Anxiety Scale scores from baseline to 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 10 days
Secondary	Changes of resting state functional connectivity from baseline to the end of the 10 day treatment period	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
Secondary	Behavioral changes from baseline to the end of the 10 day treatment period	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