Controlled Studies of Repetitive Transcranial Magnetic Stimulation (rTMS) in Chronic Posttraumatic Stress Disorder (PTSD)
Data Collection
Trauma and Stressor Related Disorders+5
+ Behavior
+ Mental Disorders
Summary
Study start date: June 1, 1997
Actual date on which the first participant was enrolled.A growing body of data indicates that patients with posttraumatic stress disorder (PTSD) have regionally selective alterations in brain metabolism and processing of information. For example, neuroimaging studies reveal increased blood flow and glucose utilization in right frontal, limbic and paralimibic brain structures in patients with PTSD, particularly when they are recalling the traumatic event associated with their symptoms. These alterations in regional brain activity are thought to be related, in part, to the distressing emotional symptoms associated with traumatic memories. Autonomic Nervous System (ANS) dysregulation is common in PTSD, with sympathetic hyper-reactivity and relative lack of parasympathetic modulation. In addition, abnormalities in hormone levels such as thyroid hormones and the hypothalmic-pituitary-adrenal axis have been demonstrated. Repetitive transcranial magnetic stimulation may provide a non-invasive technique for normalizing the alterations in regional brain metabolism, possibly leading to improvements in PTSD symptoms and concomitant improvement in ANS and hormonal balance. In particular, preliminary clinical data indicate that low frequency (i.e., approximately 0.9-1 Hz) rTMS stimulation leads to a decrease in regional cerebral blood flow. The purpose of the present study is to determine, using a placebo-controlled, parallel design, whether right frontal rTMS stimulation in patients with posttraumatic stress disorder leads to symptomatic improvement, reductions in hemispheric regional blood flow, and improvements in ANS regulation. The study hypothesis is that 1 Hz right frontal rTMS stimulation will be superior to sham stimulation in reducing PTSD symptoms and physiology including improving abnormalities in regional cerebral blood flow, vagal tone, and circulating hormone levels.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Subjects (age 18-70) meeting DSM-IV criteria for Posttraumatic Stress Disorder (PTSD). Subjects will be individuals with chronic PTSD (i.e., greater than 1 year). No subjects with evidence of uncontrolled significant medical illness on physical exam, laboratory screening or EKG, presence of cardiac pacemakers, medication pumps, cochlear implants, metal objects in the head or eyes, history of a seizure disorder, left handedness, or pregnancy. No subjects with unstable dissociative symptoms, current self-injurious behavior, current eating disorder, active substance abuse (alcohol or illicit substance use within the past three months), or active suicidality. Subjects will be allowed to be on stable doses of benzodiazepines and/or antidepressants while undergoing rTMS treatment.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institute of Mental Health (NIMH)
Bethesda, United StatesOpen National Institute of Mental Health (NIMH) in Google Maps