Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
140 participants
INTERVENTIONAL
2024-10-30
2026-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Sham stimulation
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.
sham stimulation
sham theta-burst transcranial magnetic stimulation
Active stimulation
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).
intermittent theta-burst stimulation (iTBS)
intermittent theta-burst transcranial magnetic stimulation
Interventions
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sham stimulation
sham theta-burst transcranial magnetic stimulation
intermittent theta-burst stimulation (iTBS)
intermittent theta-burst transcranial magnetic stimulation
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Shanghai Mental Health Center
OTHER
The Affiliated Kangning Hospital of Ningbo University
UNKNOWN
The First Affiliated Hospital of Anhui Medical University
OTHER
Tongji Hospital
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Yuan Shen, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Shanghai Mental Health Center
Chang Yu, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Kangning Hospital of Ningbo University
Kai Wang, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Anhui Medical University
Xiaoming Li, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
First Affiliated Hospital of Anhui Medical University
Hangzhou, Zhejiang, China
Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Affiliated Kangning Hospital of Ningbo University
Ningbo, Zhejiang, China
Tongji Hospital of Tongji University
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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yan2024-0108
Identifier Type: -
Identifier Source: org_study_id
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