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Precise Transcranial Magnetic Stimulation for Post-traumatic Stress Disorder

Primary Purpose

PTSD

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Active transcranial magnetic stimulation
Sham transcranial magnetic stimulation
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring Transcranial magnetic stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The subject, regardless of gender, aged between 18 and 60 years, is admitted to the psychosomatic outpatient department of Xijing Hospital;
  • The subject meets the diagnostic criteria of post-traumatic stress disorder in DSM-5;
  • The score of Posttraumatic Stress Disorder Checklist for DSM-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.);
  • 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.

Sites / Locations

  • XIJING HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active stimulation group

Sham stimulation group

Arm Description

Participants receive active transcranial magnetic stimulation.

Participants receive sham transcranial magnetic stimulation.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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.
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.
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.
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
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.

Full Information

First Posted
September 13, 2022
Last Updated
May 4, 2023
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05544110
Brief Title
Precise Transcranial Magnetic Stimulation for Post-traumatic Stress Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
Transcranial magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active stimulation group
Arm Type
Experimental
Arm Description
Participants receive active transcranial magnetic stimulation.
Arm Title
Sham stimulation group
Arm Type
Sham Comparator
Arm Description
Participants receive sham transcranial magnetic stimulation.
Intervention Type
Device
Intervention Name(s)
Active transcranial magnetic stimulation
Intervention Description
The coil parallel to the scalp is placed on the target for real and effective stimulation.
Intervention Type
Device
Intervention Name(s)
Sham transcranial magnetic stimulation
Intervention Description
The coil is placed perpendicular to the scalp above the target for ineffective stimulation.
Primary Outcome Measure Information:
Title
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
Description
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).
Time Frame
Baseline and Week 4 after the end of the 10 day treatment period
Secondary Outcome Measure Information:
Title
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
Description
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).
Time Frame
Baseline and 10 days
Title
Change in Hamilton Depression Scale scores from baseline to 4 Weeks after the end of 10 day treatment period
Description
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.
Time Frame
Baseline and Week 4 after the end of 10 day treatment period
Title
Change in Hamilton Depression Scale(HAMD-17)scores from baseline to the end of 10 day treatment period
Description
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.
Time Frame
Baseline and 10 days
Title
Change in Hamilton Anxiety Scale scores from baseline to 4 Weeks after the end of 10 day treatment period
Description
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.
Time Frame
Baseline and Week 4 after the end of 10 day treatment period
Title
Change in Hamilton Anxiety Scale scores from baseline to the end of 10 day treatment period
Description
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.
Time Frame
Baseline and 10 days
Title
Changes of resting state functional connectivity from baseline to the end of the 10 day treatment period
Description
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
Time Frame
Baseline and 10 days
Title
Behavioral changes from baseline to the end of the 10 day treatment period
Description
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.
Time Frame
Baseline and 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yaochi Zhang
Phone
86-18294037117
Email
a18294037117@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuyu Zhang
Phone
86-15535849017
Email
782861599@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huaning Wang
Organizational Affiliation
Xijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
XIJING Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HuaNing WANG, PhD
Email
xskzhu@fmmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31230462
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.
Results Reference
background
PubMed Identifier
32252538
Citation
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.
Results Reference
background
PubMed Identifier
26918313
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.
Results Reference
background
PubMed Identifier
29246436
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.
Results Reference
background
PubMed Identifier
30054570
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.
Results Reference
background

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Precise Transcranial Magnetic Stimulation for Post-traumatic Stress Disorder

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