Clinical trial NCT06434766: Multicenter iTBS Neuromodulation for PTSD Treatment
Official title: A Multicenter Clinical Study on Transcranial Magnetic Stimulation of the Primary Motor Cortex for PTSD Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: iTBS
PTSD
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Shanghai Mental Health Center
name: The Affiliated Kangning Hospital of Ningbo University
name: The First Affiliated Hospital of Anhui Medical University
First posted: 2024-05-30
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sham stimulation is used as a parallel control group for iTBS group.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Change in PTSD Symptom Severity
timeFrame: Baseline and 4 weeks after finishing treatment
Secondary outcomes:
measure: Change in PTSD Symptom Severity
timeFrame: Baseline, 10 times treatment, 20 times treatment, 2 weeks after finishing treatment and 8 weeks after finishing treatment
measure: Change in Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Total Score
timeFrame: Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
measure: Change in The Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR) Score
timeFrame: Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
measure: Change in The Personal Social Performance (PSP) scale
timeFrame: Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
measure: change in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
timeFrame: Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
measure: Change in neural activity pattern and functional connectivity of the brain based on fMRI
timeFrame: Baseline, 20 times treatment, 4 weeks after finishing treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
city: Hangzhou
country: China
facility: First Affiliated Hospital of Anhui Medical University
state: Zhejiang
city: Hangzhou
country: China
facility: Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Ningbo
country: China
facility: The Affiliated Kangning Hospital of Ningbo University
state: Zhejiang
Study officials:
affiliation: Shanghai Mental Health Center
name: Yuan Shen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Kangning Hospital of Ningbo University
name: Chang Yu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Anhui Medical University
name: Kai Wang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Xiaoming Li, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: