NCT00001657

Brief Summary

Posttraumatic stress disorder occurs in patients who have experienced, witnessed or have been confronted with an event involving actual death or the threat of death, serious injury, or the threat to physical health and felt fear, helplessness, or horror. As a result, patients continue to re-experience, recollect, dream, or have flashbacks about the traumatic incident. Research on PTSD continues to show metabolic changes in specific areas of the brain in patients diagnosed with PTSD. For example, neuroimaging studies (functional MRI and PET scans) reveal that blood flow and glucose utilization increases in the right frontal, limbic, and paralimbic areas of the brain in patients with PTSD, particularly when they are recalling the traumatic event associated with their symptoms. One potential method for interfering with the neuronal circuitry associated with traumatic memories is through the use of repetitive transcranial magnetic stimulation (rTMS). This technique involves the placement of a cooled electromagnet with a figure-eight coil on the patient's scalp and rapidly turning on and off the magnetic flux. This permits non-invasive, relatively localized stimulation of the surface of the brain (cerebral cortex). The effect of magnetic stimulation varies, depending upon the location, intensity and frequency of the magnetic pulses. Preliminary clinical data shows that low frequency rTMS stimulation leads to a decrease in regional cerebral blood flow. This study is designed to determine if rTMS stimulation in patients diagnosed with PTSD leads to symptomatic improvement, reductions in blood flow to specific areas of the brain, and improvements in the regulation of the autonomic nervous system.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 1997

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1997

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2000

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

August 1, 1999

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

15 O PET ScanningAnxietyCerebral Blood FlowDepressionDomestic AbuseNeuroendocrinePET ScanningPolice OfficersPost Traumatic Stress DisorderRepetitive Transcranial Magnetic Stimulation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • George MS, Wassermann EM, Williams WA, Callahan A, Ketter TA, Basser P, Hallett M, Post RM. Daily repetitive transcranial magnetic stimulation (rTMS) improves mood in depression. Neuroreport. 1995 Oct 2;6(14):1853-6. doi: 10.1097/00001756-199510020-00008.

    PMID: 8547583BACKGROUND
  • Pascual-Leone A, Houser CM, Reese K, Shotland LI, Grafman J, Sato S, Valls-Sole J, Brasil-Neto JP, Wassermann EM, Cohen LG, et al. Safety of rapid-rate transcranial magnetic stimulation in normal volunteers. Electroencephalogr Clin Neurophysiol. 1993 Apr;89(2):120-30. doi: 10.1016/0168-5597(93)90094-6.

    PMID: 7683602BACKGROUND
  • Rauch SL, van der Kolk BA, Fisler RE, Alpert NM, Orr SP, Savage CR, Fischman AJ, Jenike MA, Pitman RK. A symptom provocation study of posttraumatic stress disorder using positron emission tomography and script-driven imagery. Arch Gen Psychiatry. 1996 May;53(5):380-7. doi: 10.1001/archpsyc.1996.01830050014003.

    PMID: 8624181BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

June 1, 1997

Study Completion

May 1, 2000

Last Updated

March 4, 2008

Record last verified: 1999-08

Locations