N/A
Completed N=31
rTMS in the Treatment of PTSD
Source: ClinicalTrials.gov NCT01806168 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) — 59.80; 74.00; 65.12 units on a scale — p=0.046
Summary
The purpose of this study is to assess the effects of repetitive transcranial magnetic stimulation (rTMS) in civilian patients with a confirmed diagnosis of post-traumatic stress disorder (PTSD). This research study will determine whether low-frequency (1 Hertz [Hz]) or high-frequency (10 Hz) rTMS over the right dorsolateral prefrontal cortex (DLPFC) has an effect on symptoms of PTSD compared to sham rTMS treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) |
59.80; 74.00; 65.12 | 0.046 sig |
| SECONDARY PTSD Checklist for Civilians (PCL-C) |
48.10; 53.44; 52.14 | 0.93 |
| SECONDARY Hamilton Depression Rating Scale, 21-item Version (HDRS-21) |
12.30; 11.22; 14.44 | 0.18 |
| SECONDARY Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) |
12.66; 15.00; 9.42 | 0.54 |
| SECONDARY Beck Anxiety Inventory (BAI) |
24.70; 22.77; 28.14 | 0.86 |
| SECONDARY Generalized Anxiety Disorder (GAD-7) Scale |
11.90; 8.50; 11.75 | 0.4 |
Eligibility Criteria
Inclusion Criteria
- primary diagnosis of PTSD as determined by a structured interview using the Mini International Neuropsychiatric Interview (MINI)
- no change in psychotropic medications within 4 weeks before the start of rTMS
- age > 19 years and < 70 years
- competency to give informed consent
Exclusion Criteria
- any non-fixed metal object or implant (including cochlear implants) in brain, skull, scalp, or neck within 30 cm of the magnetic rTMS coil
- implantable devices, including cardiac pacemakers and defibrillators
- other contraindications to rTMS, including history of seizures (except childhood febrile seizures) or recent and unexplained syncope, first-degree relative with a history of epilepsy, treatment with a medication known to substantially decrease the seizure threshold, or pregnancy
- psychiatric diagnoses of psychosis or psychotic disorder (including psychotic depression), bipolar type I disorder, or organic mental disorders
- substance abuse/dependence within the past 3 months
- active suicidal risk as judged by the clinician
- borderline or antisocial personality disorder
- acute medical illness, including cancer
- any significant central nervous system disorder, such as brain mass, stroke, etc.
Data sourced from ClinicalTrials.gov (NCT01806168). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.