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NCT Number: NCT06434766

Multicenter iTBS Neuromodulation 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Mental Health Center, Shanghai, Shanghai Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sham stimulation

Device

sham theta-burst transcranial magnetic stimulation

Intermittent theta-burst stimulation (iTBS)

Device

intermittent theta-burst transcranial magnetic stimulation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 PTSD symptom severity measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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).

  6. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Huiqian Huang, Ph.D.

CONTACT

[email protected]

+8618757143725

Shanshan Li, Bachelor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • Shanghai Mental Health Center
  • The Affiliated Kangning Hospital of Ningbo University
  • The First Affiliated Hospital of Anhui Medical University
  • Tongji Hospital

Registry information

Official study title

A Multicenter Clinical Study on Transcranial Magnetic Stimulation of the Primary Motor Cortex for PTSD Treatment

Acronym: TMCP

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 30, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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