Multicenter iTBS Neuromodulation for PTSD Treatment (TMCP)

Zhejiang University

Status: Enrolling

Conditions: Posttraumatic Stress Disorder

Treatments: Device: sham stimulation; Device: intermittent theta-burst stimulation (iTBS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06434766

yan2024-0108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups

Sham stimulation

Sham Comparator group

Description:

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.

Treatment:

Device: sham stimulation

Active stimulation

Active Comparator group

Description:

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).

Treatment:

Device: intermittent theta-burst stimulation (iTBS)