Posttraumatic Stress DisorderNCT00001657
Use of Repetitive Transcranial Magnetic Stimulation (rTMS) in Chronic Posttraumatic Stress Disorder (PTSD)
An observational study of Posttraumatic Stress Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Posttraumatic Stress Disorder
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1997to May 2000
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
Official title: Controlled Studies of Repetitive Transcranial Magnetic Stimulation (rTMS) in Chronic Posttraumatic Stress Disorder (PTSD)
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.
Read more
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.
Read the 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 (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.
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- 15 O PET Scanning, Anxiety, Cerebral Blood Flow, Depression, Domestic Abuse, Neuroendocrine, PET Scanning, Police Officers, Post Traumatic Stress Disorder, Repetitive Transcranial Magnetic Stimulation
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startJun 1997
- Study completionMay 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001657
- Sponsor's protocol ID
- 970128
- Other IDs
- 97-M-0128
- Status last verified
- Aug 1999
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 8547583Pascual-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.
PubMed 7683602Rauch 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.
PubMed 8624181
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Studies of Repetitive Transcranial Magnetic Stimulation (rTMS) in Chronic Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT00001657
- Acronym / sponsor ID
- 970128
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- 15 O PET Scanning, Anxiety, Cerebral Blood Flow, Depression, Domestic Abuse, Neuroendocrine, PET Scanning, Police Officers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Jun 1997
- Study completion
- May 2000
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8547583George 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.
- Background: PubMed 7683602Pascual-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.
- Background: PubMed 8624181Rauch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posttraumatic Stress Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001657, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.