Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001657
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Use of Repetitive Transcranial Magnetic Stimulation rTMS in Chronic Posttraumatic Stress Disorder PTSD
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Controlled Studies of Repetitive Transcranial Magnetic Stimulation rTMS in Chronic Posttraumatic Stress Disorder PTSD
Status:
COMPLETED
Status Verified Date:
1999-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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 patients 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
Detailed Description:
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 ie approximately 09-1 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 97-M-0128 | None | None | None |