Precise Transcranial Magnetic Stimulation for Post-traumatic Stress Disorder

NCT05544110 | Unknown DMC

• 1 other identifier: KY20222176-F-1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Conditions

PTSD

Keywords

Transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• 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

• Change in Hamilton Depression Scale（HAMD-17）scores from baseline to the end of 10 day treatment period

  Baseline and 10 days

• 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

• Change in Hamilton Anxiety Scale scores from baseline to the end of 10 day treatment period

  Baseline and 10 days

Study Arms (2)

Active stimulation group

EXPERIMENTAL

Participants receive active transcranial magnetic stimulation.

Device: Active transcranial magnetic stimulation

Sham stimulation group

SHAM COMPARATOR

Participants receive sham transcranial magnetic stimulation.

Device: Sham transcranial magnetic stimulation

Interventions

Active transcranial magnetic stimulation DEVICE

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

Active stimulation group

Sham transcranial magnetic stimulation DEVICE

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

Sham stimulation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

XIJING Hospital

Xi'an, Shaanxi, 710000, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 31230462 BACKGROUND

• 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.

  PMID: 32252538 BACKGROUND

• 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.

  PMID: 26918313 BACKGROUND

• 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.

  PMID: 29246436 BACKGROUND

• 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.

  PMID: 30054570 BACKGROUND

• Zhang Y, Peng Z, Tang N, Zhang Y, Liu N, Lv R, Meng Y, Cai M, Wang H. Efficacy of MRI-guided rTMS for post-traumatic stress disorder by modulating amygdala activity: study protocol for a randomised controlled trial. BMJ Open. 2024 Jul 3;14(7):e081751. doi: 10.1136/bmjopen-2023-081751.

  PMID: 38960463 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Huaning Wang

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaochi Zhang

CONTACT

86-18294037117; a18294037117@163.com

Yuyu Zhang

CONTACT

86-15535849017; 782861599@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 16, 2022
• Study Start: February 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: January 11, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)