Multicenter iTBS Neuromodulation for PTSD Treatment

Posttraumatic Stress Disorder Clinical Trial

— TMCP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06434766
• Other study ID #: yan2024-0108
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Huiqian Huang, Ph.D.
• Phone: (+86)18757143725
• Email: hhq0301[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: May 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

Device:
• sham stimulation
sham theta-burst transcranial magnetic stimulation
• intermittent theta-burst stimulation (iTBS)
intermittent theta-burst transcranial magnetic stimulation

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Shanghai Mental Health Center, The Affiliated Kangning Hospital of Ningbo University, The First Affiliated Hospital of Anhui Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PTSD Symptom Severity	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.	Baseline and 4 weeks after finishing treatment
Secondary	Change in PTSD Symptom Severity	Change in PTSD symptom severity measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).	Baseline, 10 times treatment, 20 times treatment, 2 weeks after finishing treatment and 8 weeks after finishing treatment
Secondary	Change in Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Total Score	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.	Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
Secondary	Change in The Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR) Score	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.	Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
Secondary	Change in The Personal Social Performance (PSP) scale	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.	Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
Secondary	change in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)	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).	Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
Secondary	Change in neural activity pattern and functional connectivity of the brain based on fMRI	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.	Baseline, 20 times treatment, 4 weeks after finishing treatment