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Recruiting
NCT06434766
Multicenter iTBS Neuromodulation for PTSD Treatment
Conditions: Posttraumatic Stress Disorder
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 140
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Location: Shanghai Mental Health Center Shanghai Shanghai Municipality
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. 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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT06434766). StuddyBuddy aggregates publicly available trial information.