Multicenter iTBS Neuromodulation for PTSD Treatment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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

Qualifiers

Aged between 18 to 65 years old

Right handedness

Have a diagnosis of PTSD meeting DSM-5 criteria

CAPS-5 score>35

Disqualifiers

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

Trial design

Treatments tested in this trial

  • sham stimulation
  • intermittent theta-burst stimulation (iTBS)

Treatment groups

140 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Shanghai Mental Health Center

Collaborator

The Affiliated Kangning Hospital of Ningbo University

Collaborator

The First Affiliated Hospital of Anhui Medical University

Collaborator

Tongji Hospital

Collaborator