Posttraumatic Stress Disorder
Conditions
Keywords
iTBS, PTSD
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.
Interventions
DEVICEsham stimulation
sham theta-burst transcranial magnetic stimulation
intermittent theta-burst transcranial magnetic stimulation
Sponsors
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
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants, investigators and outcomes assessors are all blind to the group assignments.
Intervention model description
Sham stimulation is used as a parallel control group for iTBS group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PTSD Symptom Severity | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in PTSD Symptom Severity | 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). |
| Change in Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Total Score | 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. |
| Change in The Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR) Score | 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. |
| Change in The Personal Social Performance (PSP) scale | 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. |
| change in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) | 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). |
| Change in neural activity pattern and functional connectivity of the brain based on fMRI | 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. |
Countries
China
Contacts
CONTACTHuiqian Huang, Ph.D.
CONTACTShanshan Li, Bachelor
PRINCIPAL_INVESTIGATORYuan Shen, M.D., Ph.D.
Tongji Hospital
PRINCIPAL_INVESTIGATORChang Yu, M.D.
The Affiliated Kangning Hospital of Ningbo University
PRINCIPAL_INVESTIGATORKai Wang, M.D., Ph.D.
The First Affiliated Hospital of Anhui Medical University
PRINCIPAL_INVESTIGATORXiaoming Li, M.D., Ph.D.
Second Affiliated Hospital, School of Medicine, Zhejiang University
PRINCIPAL_INVESTIGATORZhen Wang, M.D., Ph.D.
Shanghai Mental Health Center
Outcome results
None listed