Posttraumatic Stress DisorderTMCPNCT06434766
Multicenter iTBS Neuromodulation for PTSD Treatment
A study testing intermittent theta-burst stimulation (iTBS) in people with Posttraumatic Stress Disorder, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 5 sites in China.
Trial summary
The proposed study aims to evaluate the efficacy of intermittent theta-burst transcranial magnetic stimulation (iTBS) targeting primary motor cortex (M1) as adjunct treatment for PTSD patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- intermittent theta-burst stimulation (iTBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 5 sitesChina
- Study dates
- 30 Oct 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged between 18 to 65 years old
- Right handedness
- Have a diagnosis of PTSD meeting DSM-5 criteria
- CAPS-5 score>35
- Under stable medication for at least four weeks
- Capable of independently reading and understanding study materials and providing informed consent.
Who cannot join
- Current (or past if appropriate) significant neurological or medical disorder, or lifetime history of 1) seizure disorder; 2) primary or secondary CNS tumors; 3) stroke; or 4) cerebral aneurysm.
- Primary psychotic disorder, bipolar I disorder, major depressive disorder, or personality disorders
- Lifetime history of attempted suicide or HAMD-17 suicide item (item 3) ≥ 3 points
- Implanted device (deep brain stimulation) or metal in the brain; a pacemaker, extensive dental work, or any magnetic metal implants and upper body tattoos if choose to do fMRI
- Previous experience of rTMS
- Pregnancy/lactation, or planning to become pregnant during the study
- Current under psychological or other physical treatments
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Shanshan Li, Bachelor contact
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
First Affiliated Hospital of Anhui Medical University
Hangzhou, Zhejiang
Gongjun Ji, Ph.D., +86055165167581, jigongjun@163.com
Kai Wang, M.D., Ph.D.
- Recruiting
Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Huiqian Huang, Ph.D., (+86)057188206092, hhq0301@zju.edu.cn
Shanshan Li, Bachelor, +8615867111248, 1252037349@qq.com
- Recruiting
The Affiliated Kangning Hospital of Ningbo University
Ningbo, Zhejiang
Wenhao Zhuang, M.D., +8615888178517, zwhphil@163.com
Chang Yu, M.D.
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality
Binxin Huang, M.D., Ph.D., +86177 0179 5651, huangbinxin2022@163.com
Zhen Wang, M.D., Ph.D.
- Recruiting
Tongji Hospital of Tongji University
Shanghai
Xinchun Mei, 021-51030581, xinchun0416@163.com
Yuan Shen, M.D., Ph.D.
About this study
Official title: A Multicenter Clinical Study on Transcranial Magnetic Stimulation of the Primary Motor Cortex for PTSD Treatment
The proposed study aims to evaluate the efficacy of intermittent theta-burst transcranial magnetic stimulation (iTBS) targeting primary motor cortex (M1) as adjunct treatment for PTSD patients. The primary outcome measure includes changes in PTSD symptom severity, with secondary outcome measures focusing on negative moods improvements, quality of life and social/occupation functioning and functional connectivity of the brain.
Read the detailed description
The proposed study aims to evaluate the efficacy of intermittent theta-burst transcranial magnetic stimulation (iTBS) targeting primary motor cortex as adjunct treatment for PTSD patients.
Compared to traditional repetitive transcranial magnetic stimulation (rTMS), iTBS strategy usually delivers large amounts of pulses in a shorter time period, and its equal efficiency has been demonstrated in several psychiatric disorders such as major depressive disorder (MDD). Through this adequately randomized and sham-controlled study of iTBS for PTSD, this work will provide an alternative and potentially more potent stimulation target for clinical PTSD treatment. This study will also provide a comprehensive assessment of this treatment strategy towards improvements in symptoms, quality of life and brain functioning in PTSD.
The ultimate goal of this study is to develop a non-invasive brain stimulation approach targeting a novel site for alleviating symptoms and improving life quality for PTSD patients.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- sham stimulation, intermittent theta-burst stimulation (iTBS)
- Keywords
- iTBS, PTSD
- 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.
sham stimulationDevice
sham theta-burst transcranial magnetic stimulation
intermittent theta-burst stimulation (iTBS)Device
intermittent theta-burst transcranial magnetic stimulation
| Study group | Role | What they receive |
|---|---|---|
| Sham stimulation | Sham comparator | A sham coil with exactly the same appearance of active coil is used to compare with active coil. Stimulation dose and frequency is the same as active stimulation. Receives: Device: sham stimulation |
| Active stimulation | Active comparator | An active coil is used to deliver iTBS. The stimulation dose is 20 sessions (1800 pulses per session; 2 sessions a day, at least 1 hour apart) over the course of 2 weeks (10 days to 14 days, allow at most three breaks and only once of the longest interval of 2 days). Receives: Device: intermittent theta-burst stimulation (iTBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Symptom Severity
Change in PTSD symptom severity measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).
The CAPS-5 is a structured interview designed to make a categorical PTSD diagnosis, as well as to provide a measure of PTSD symptom severity. The structure corresponds to the DSM-5 criteria, with B, C, D and E symptoms rated for both frequency and intensity which are summed to provide severity ratings. Items rated '0' means 'absent' and item rated '4' means 'extreme/incapacitating'. Higher scores indicate more severe PTSD symptoms.
Measured: Baseline and 4 weeks after finishing treatment
Secondary outcomes (6)
Change in PTSD Symptom Severity
Change in PTSD symptom severity measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).
Measured: Baseline, 10 times treatment, 20 times treatment, 2 weeks after finishing treatment and 8 weeks after finishing treatment
Change in Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Total Score
The PCL-5 is a 20-item self-report checklist of PTSD symptoms based closely on the DSM-5 criteria. Respondents rate each item from 0 ("not at all") to 4 ("extremely") to indicate the degree to which they have been bothered by that particular symptom over the past month (or past week if using the PCL-5 weekly). A total symptom severity score (range: 0-80) can be obtained by summing the scores for each of the 20 items, with higher scores indicating more severe PTSD symptoms.
Measured: Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
Change in The Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR) Score
The IDS-SR is a 30-item questionnaire measuring depressive symptoms. Each item has four statements that reflect various degrees of symptom severity, scored on a four-point scale from 0 to 3. The 16-item Quick Inventory of Depressive Symptomatology (QIDS) is a new measure of depressive symptom severity derived from the 30-item IDS-SR and has highly acceptable psychometric properties.
Measured: Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
Change in The Personal Social Performance (PSP) scale
The Personal and Social Performance Scale (PSP) is a 100-point single-item rating scale that assesses four important domains of patients with mental disorders. The four main areas include (a) socially useful activities, including work and study; (b) personal and social relationships; (c) self-care; and (d) disturbing and aggressive behaviors.
Measured: Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
change in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
Q-LES-Q-SF is a patient-reported 16-item instrument that measures the degree of enjoyment and satisfaction in daily life over the past week. Individual items are rated on a scale from 1-5 ('very poor', 'poor', 'fair', 'good', or 'very good'). The Q-LES-Q-SF total score is the sum of the first 14 item scores (i.e. excluding medication satisfaction and overall life satisfaction and contentment) with a higher score indicating greater satisfaction (range = 14-70).
Measured: Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
Change in neural activity pattern and functional connectivity of the brain based on fMRI
Structural, resting-state and task-based fMRI will be performed if the participant agree. During task-fMRI, the participant will listen to a script around one minute recorded during his/her first interview, describing the traumatic experience in details. The participant will be instructed to recall the traumatic experience vividly during the task-fMRI. Brain activity patterns and connectivity network will be presented and analyzed.
Measured: Baseline, 20 times treatment, 4 weeks after finishing treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start30 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Model description
- Sham stimulation is used as a parallel control group for iTBS group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Mental Health Center, The Affiliated Kangning Hospital of Ningbo University, The First Affiliated Hospital of Anhui Medical University, Tongji Hospital
- Responsible party
- Sponsor
- Investigators
- Yuan Shen, M.D., Ph.D., Principal investigator, Tongji HospitalChang Yu, M.D., Principal investigator, The Affiliated Kangning Hospital of Ningbo UniversityKai Wang, M.D., Ph.D., Principal investigator, The First Affiliated Hospital of Anhui Medical UniversityXiaoming Li, M.D., Ph.D., Principal investigator, Second Affiliated Hospital, Zhejiang University, School of MedicineZhen Wang, M.D., Ph.D., Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434766
- Sponsor's protocol ID
- yan2024-0108
- Acronym
- TMCP
- Status last verified
- Apr 2026
- First submitted
- 15 May 2024
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study on Transcranial Magnetic Stimulation of the Primary Motor Cortex for PTSD Treatment
- ClinicalTrials.gov ID
- NCT06434766
- Acronym / sponsor ID
- TMCP / yan2024-0108
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- iTBS, PTSD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Mental Health Center, The Affiliated Kangning Hospital of Ningbo University, The First Affiliated Hospital of Anhui Medical University, Tongji Hospital
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 30 May 2024 (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 proposed study aims to evaluate the efficacy of intermittent theta-burst transcranial magnetic stimulation (iTBS) targeting primary motor cortex (M1) as adjunct treatment for PTSD patients. The primary outcome measure includes changes in PTSD symptom severity, with secondary outcome measures focusing on negative moods improvements, quality of life and social/occupation functioning and functional connectivity of the brain.
Detailed description
The proposed study aims to evaluate the efficacy of intermittent theta-burst transcranial magnetic stimulation (iTBS) targeting primary motor cortex as adjunct treatment for PTSD patients.
Compared to traditional repetitive transcranial magnetic stimulation (rTMS), iTBS strategy usually delivers large amounts of pulses in a shorter time period, and its equal efficiency has been demonstrated in several psychiatric disorders such as major depressive disorder (MDD). Through this adequately randomized and sham-controlled study of iTBS for PTSD, this work will provide an alternative and potentially more potent stimulation target for clinical PTSD treatment. This study will also provide a comprehensive assessment of this treatment strategy towards improvements in symptoms, quality of life and brain functioning in PTSD.
The ultimate goal of this study is to develop a non-invasive brain stimulation approach targeting a novel site for alleviating symptoms and improving life quality for PTSD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Sham stimulation is used as a parallel control group for iTBS group.
| Arm | Type | Receives |
|---|---|---|
| Sham stimulation | Sham comparator | Device: sham stimulationA sham coil with exactly the same appearance of active coil is used to compare with active coil. Stimulation dose and frequency is the same as active stimulation. |
| Active stimulation | Active comparator | Device: intermittent theta-burst stimulation (iTBS)An active coil is used to deliver iTBS. The stimulation dose is 20 sessions (1800 pulses per session; 2 sessions a day, at least 1 hour apart) over the course of 2 weeks (10 days to 14 days, allow at most three breaks and only once of the longest interval of 2 days). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 18 to 65 years old
- Right handedness
- Have a diagnosis of PTSD meeting DSM-5 criteria
- CAPS-5 score>35
- Under stable medication for at least four weeks
Key exclusion criteria (7 listed)
- Current (or past if appropriate) significant neurological or medical disorder, or lifetime history of 1) seizure disorder; 2) primary or secondary CNS tumors; 3) stroke; or 4) cerebral aneurysm.
- Primary psychotic disorder, bipolar I disorder, major depressive disorder, or personality disorders
- Lifetime history of attempted suicide or HAMD-17 suicide item (item 3) ≥ 3 points
- Implanted device (deep brain stimulation) or metal in the brain; a pacemaker, extensive dental work, or any magnetic metal implants and upper body tattoos if choose to do fMRI
- Previous experience of rTMS
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 |
|---|---|---|
| sham stimulationsham theta-burst transcranial magnetic stimulation | Device | Sham stimulation |
| intermittent theta-burst stimulation (iTBS)intermittent theta-burst transcranial magnetic stimulation | Device | Active stimulation |
Primary outcome
Change in PTSD Symptom Severity
Time frame: Baseline and 4 weeks after finishing treatment
Change in PTSD symptom severity measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5). The CAPS-5 is a structured interview designed to make a categorical PTSD diagnosis, as well as to provide a measure of PTSD symptom severity. The structure corresponds to the DSM-5 criteria, with B, C, D and E symptoms rated for both frequency and intensity which are summed to provide severity ratings. Items rated '0' means 'absent' and item rated '4' means 'extreme/incapacitating'. Higher scores indicate more severe PTSD symptoms.
6 secondary outcomes
Change in PTSD Symptom Severity
Time frame: Baseline, 10 times treatment, 20 times treatment, 2 weeks after finishing treatment and 8 weeks after finishing treatment
Change in Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Total Score
Time frame: Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
Change in The Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR) Score
Time frame: Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
Change in The Personal Social Performance (PSP) scale
Time frame: Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
change in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
Time frame: Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
Change in neural activity pattern and functional connectivity of the brain based on fMRI
Time frame: Baseline, 20 times treatment, 4 weeks after finishing treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- 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.
Shanshan Li, Bachelor contact
Yuan Shen, M.D., Ph.D. principal investigator
Tongji Hospital
Chang Yu, M.D. principal investigator
The Affiliated Kangning Hospital of Ningbo University
Kai Wang, M.D., Ph.D. principal investigator
The First Affiliated Hospital of Anhui Medical University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermittent theta-burst stimulation (iTBS) in people with Posttraumatic Stress Disorder, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 5 sites 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huiqian Huang, Ph.D. (+8618757143725, hhq0301@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD Symptom Severity (time frame: Baseline and 4 weeks after finishing treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2026.