PTSDNCT05544110
Precise Transcranial Magnetic Stimulation for Post-traumatic Stress Disorder
A study testing Active transcranial magnetic stimulation in people with PTSD, run by Xijing Hospital at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD
- What is being tested?
- Active transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
XIJING Hospital
Xi'an, Shaanxi, 710000
HuaNing WANG, PhD, xskzhu@fmmu.edu.cn
About this study
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
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
Read the 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.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
- PTSD
- Being tested
- Active transcranial magnetic stimulation, Sham transcranial magnetic stimulation
- Keywords
- Transcranial magnetic stimulation
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active transcranial magnetic stimulationDevice
The coil parallel to the scalp is placed on the target for real and effective stimulation.
Sham transcranial magnetic stimulationDevice
The coil is placed perpendicular to the scalp above the target for ineffective stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation group | Experimental | Participants receive active transcranial magnetic stimulation. Receives: Device: Active transcranial magnetic stimulation |
| Sham stimulation group | Sham comparator | Participants receive sham transcranial magnetic stimulation. Receives: Device: Sham transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: Baseline and 10 days
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.
Measured: 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
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.
Measured: Baseline and 10 days
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.
Measured: 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
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.
Measured: Baseline and 10 days
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
Measured: Baseline and 10 days
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.
Measured: Baseline and 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Feb 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huaning Wang, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544110
- Sponsor's protocol ID
- KY20222176-F-1
- Status last verified
- Feb 2023
- First submitted
- 13 Sep 2022
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31230462Cole 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.
PubMed 32252538Koch 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.
PubMed 26918313Raij 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.
PubMed 29246436Fenster 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.
PubMed 30054570Zhang 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.
PubMed 38960463
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05544110
- Acronym / sponsor ID
- KY20222176-F-1
- Conditions
- PTSD
- Keywords
- Transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation group | Experimental | Device: Active transcranial magnetic stimulationParticipants receive active transcranial magnetic stimulation. |
| Sham stimulation group | Sham comparator | Device: Sham transcranial magnetic stimulationParticipants receive sham transcranial magnetic stimulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active transcranial magnetic stimulationThe coil parallel to the scalp is placed on the target for real and effective stimulation. | Device | Active stimulation group |
| Sham transcranial magnetic stimulationThe coil is placed perpendicular to the scalp above the target for ineffective stimulation. | Device | Sham stimulation group |
Primary outcome
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
Time frame: Baseline and Week 4 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).
7 secondary outcomes
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
Time frame: Baseline and 10 days
Change in Hamilton Depression Scale scores from baseline to 4 Weeks after the end of 10 day treatment period
Time frame: 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
Time frame: Baseline and 10 days
Change in Hamilton Anxiety Scale scores from baseline to 4 Weeks after the end of 10 day treatment period
Time frame: 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
Time frame: Baseline and 10 days
Changes of resting state functional connectivity from baseline to the end of the 10 day treatment period
Time frame: Baseline and 10 days
Behavioral changes from baseline to the end of the 10 day treatment period
Time frame: Baseline and 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Background: PubMed 31230462Philip 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.
- Background: PubMed 32252538Cole 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.
- Background: PubMed 26918313Koch 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.
- Background: PubMed 29246436Raij 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.
- Background: PubMed 30054570Fenster 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.
- Derived from this study: PubMed 38960463Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huaning Wang principal investigator
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active transcranial magnetic stimulation in people with PTSD, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaochi Zhang (86-18294037117, a18294037117@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline and Week 4 after the end of the 10 day treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05544110, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.