Post-Traumatic Stress DisorderNCT01020695
Quantitative Electroencephalography (QEEG) and Low-resolution Electromagnetic Tomography (LORETA) Analysis in Post Traumatic Stress Disorder (PTSD) Patients
An observational study of Post-Traumatic Stress Disorder, run by Beersheva Mental Health Center at 1 site in Israel.
Trial summary
In this study the Quantitative Electroencephalography and low resolution topographic analysis of chronic Post-traumatic stress disorder and normal subjects will be compared. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorder
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2009to Nov 2009
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Veterans with chronic PTSD of at least 2 years.
Who may be able to join
- 10 veterans suffering for PTSD according to the DSM-IV-TR for at least 2 years.
- The 10 age matching controls will be recruited from the Beer Sheva mental stuff.
Who cannot join
- Without any neurological or head trauma.
- Without alcohol or substance abuse.
- No evidence of psychotic episode in there history.
- Stable doses of different specific serotonin reuptake inhibitors (SSRI) antidepressant for at least two months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: QEEG and LORETA Analysis in PTSD Patients
In this study the Quantitative Electroencephalography and low resolution topographic analysis of chronic Post-traumatic stress disorder and normal subjects will be compared.
Read the detailed description
Post-traumatic stress disorder (PTSD) is defined as a constellation of symptoms in response to a stressor, including re-experiencing a traumatic event, numbed responsiveness and symptoms of an increased level of arousal (APA 2000) . In recent years there were many attempts to connect the brain structure and function to symptoms in PTSD patients (Francati, Vermetten et al. 2007; Liberzon and Sripada 2008). One of the important technologies in this regard is the Electroencephalography (EEG) measurement.
The EEG is the reflection of the inner brain electrical changing dipole as it is measured on the scalp. It is measured by electrode that placed on the head according to the international distribution of electrodes called 10-20. The EEG recording that is the product of the measurement can be analyzed at least in three different levels: visual inspection of the raw EEG, quantities analysis of the EEG (QEEG) and based on the QEEG, calculating the electrical distribution of dipoles inside the brain that creates the EEG signal (Niedermeyer and Lopes da Silva 2005). Theoretically two EEG measurements could have the same visual EEG and/or QEEG patterns but the inner brain electrical dipole distribution could be very different. The mathematical solution to the calculation of the dipole distribution inside the brain, using the scalp EEG is based on "the inverse problem" concepts. One of the more common and precise method to solve the inverse problem regarding the EEG is called LORETA (low resolution topographic analysis) (Pascual-Marqui, Michel et al. 1994; Pascual-Marqui, Esslen et al. 2002). There are many brain image technologies aiming on mapping the connection between brain function and psychopathology. Each method caries with it both advantage and drawbacks. The use of the Electroencephalographic mapping technique is no different and it's main advantage - the temporal resolution is with opposition to the relatively lower spatial resolution. Modern signal processing tools and software like the LORETA start challenging this equation and in the last years some articles were published proving the possibilities of using EEG measurement to localized brain function with high spatial-resolution (Stern, Neufeld et al. 2009) .
The study will focus on the rest QEEG and rest LORETA analysis in PTSD patients.
Previous QEEG research found conflicting results regarding the spectral distribution of the EEG waves across the scalp.
Begic et al (Begic, Hotujac et al. 2001) compared 18 PTSD veterans to 20 controls. They found that PTSD patients had increased theta activity over central regions, and they had increased beta activity over frontal, central and occipital regions. No significant differences were noted between the PTSD and control group in both the delta and alpha activity. In this study all the patients were medication free for 2 weeks.
In another study the same group compared veterans with PTSD to veterans without PTSD. In this study the PTSD patients had decreased alpha power and increased beta power. No difference was noted on the theta band in this study (Jokic-Begic and Begic 2003).
In a recent study another group studied the hemispheric asymmetries among motor vehicle survivors with PTSD, with subsyndromal PTSD, survivors without PTSD and nonexposed healthy controls during rest (baseline) and in response to neutral, positive, negative, and trauma-related pictures. They focus on the alpha band. They found no group differences in EEG alpha activity during the baseline condition. In there study all the patients were without medication for 1 month (Rabe, Beauducel et al. 2006). Shankman et al compared the resting EEG of PTSD patients to "super- controls" in order to maximized the difference between this two groups. They found no statistical significant difference in any of the spectral band (Shankman, Silverstein et al. 2008).
The aim of this study is to calculate the QEEG difference and to do LORETA analysis in PTSD patients compared to controls.
In order to avoid statistical multiple compressing problems this study will focus on the theta band. There are at least two reasons for this: the first is that due to ethical issue we don't ask our patients to stop there psychotropic treatments therefore all of them are using SSRI antidepressants which could cause some alpha rhythms changes (Niedermeyer and Lopes da Silva 2005). Another reason is that the origin of the theta bend is supposed to be the in limbic system (Niedermeyer and Lopes da Silva 2005) that is long ago connected to PTSD symptoms (Francati, Vermetten et al. 2007).
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- PTSD, EEG, QEEG, LORETA
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PTSD veterans | 18 PTSD veterans | |
| controls | 20 controls |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beersheva Mental Health Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Doron Todder, Beersheva Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020695
- Sponsor's protocol ID
- BHC-4917
- Status last verified
- Nov 2012
- First submitted
- 23 Nov 2009
- Last updated
- 7 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QEEG and LORETA Analysis in PTSD Patients
- ClinicalTrials.gov ID
- NCT01020695
- Acronym / sponsor ID
- BHC-4917
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- PTSD, EEG, QEEG, LORETA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Beersheva Mental Health CenterOther government
- Study start
- Nov 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 25 Nov 2009 (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.
In this study the Quantitative Electroencephalography and low resolution topographic analysis of chronic Post-traumatic stress disorder and normal subjects will be compared.
Detailed description
Post-traumatic stress disorder (PTSD) is defined as a constellation of symptoms in response to a stressor, including re-experiencing a traumatic event, numbed responsiveness and symptoms of an increased level of arousal (APA 2000) . In recent years there were many attempts to connect the brain structure and function to symptoms in PTSD patients (Francati, Vermetten et al. 2007; Liberzon and Sripada 2008). One of the important technologies in this regard is the Electroencephalography (EEG) measurement.
The EEG is the reflection of the inner brain electrical changing dipole as it is measured on the scalp. It is measured by electrode that placed on the head according to the international distribution of electrodes called 10-20. The EEG recording that is the product of the measurement can be analyzed at least in three different levels: visual inspection of the raw EEG, quantities analysis of the EEG (QEEG) and based on the QEEG, calculating the electrical distribution of dipoles inside the brain that creates the EEG signal (Niedermeyer and Lopes da Silva 2005). Theoretically two EEG measurements could have the same visual EEG and/or QEEG patterns but the inner brain electrical dipole distribution could be very different. The mathematical solution to the calculation of the dipole distribution inside the brain, using the scalp EEG is based on "the inverse problem" concepts. One of the more common and precise method to solve the inverse problem regarding the EEG is called LORETA (low resolution topographic analysis) (Pascual-Marqui, Michel et al. 1994; Pascual-Marqui, Esslen et al. 2002). There are many brain image technologies aiming on mapping the connection between brain function and psychopathology. Each method caries with it both advantage and drawbacks. The use of the Electroencephalographic mapping technique is no different and it's main advantage - the temporal resolution is with opposition to the relatively lower spatial resolution. Modern signal processing tools and software like the LORETA start challenging this equation and in the last years some articles were published proving the possibilities of using EEG measurement to localized brain function with high spatial-resolution (Stern, Neufeld et al. 2009) .
The study will focus on the rest QEEG and rest LORETA analysis in PTSD patients.
Previous QEEG research found conflicting results regarding the spectral distribution of the EEG waves across the scalp.
Begic et al (Begic, Hotujac et al. 2001) compared 18 PTSD veterans to 20 controls. They found that PTSD patients had increased theta activity over central regions, and they had increased beta activity over frontal, central and occipital regions. No significant differences were noted between the PTSD and control group in both the delta and alpha activity. In this study all the patients were medication free for 2 weeks.
In another study the same group compared veterans with PTSD to veterans without PTSD. In this study the PTSD patients had decreased alpha power and increased beta power. No difference was noted on the theta band in this study (Jokic-Begic and Begic 2003).
In a recent study another group studied the hemispheric asymmetries among motor vehicle survivors with PTSD, with subsyndromal PTSD, survivors without PTSD and nonexposed healthy controls during rest (baseline) and in response to neutral, positive, negative, and trauma-related pictures. They focus on the alpha band. They found no group differences in EEG alpha activity during the baseline condition. In there study all the patients were without medication for 1 month (Rabe, Beauducel et al. 2006). Shankman et al compared the resting EEG of PTSD patients to "super- controls" in order to maximized the difference between this two groups. They found no statistical significant difference in any of the spectral band (Shankman, Silverstein et al. 2008).
The aim of this study is to calculate the QEEG difference and to do LORETA analysis in PTSD patients compared to controls.
In order to avoid statistical multiple compressing problems this study will focus on the theta band. There are at least two reasons for this: the first is that due to ethical issue we don't ask our patients to stop there psychotropic treatments therefore all of them are using SSRI antidepressants which could cause some alpha rhythms changes (Niedermeyer and Lopes da Silva 2005). Another reason is that the origin of the theta bend is supposed to be the in limbic system (Niedermeyer and Lopes da Silva 2005) that is long ago connected to PTSD symptoms (Francati, Vermetten et al. 2007).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTSD veterans | – | –18 PTSD veterans |
| controls | – | –20 controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans with chronic PTSD of at least 2 years.
Key inclusion criteria (2 listed)
- 10 veterans suffering for PTSD according to the DSM-IV-TR for at least 2 years.
- The 10 age matching controls will be recruited from the Beer Sheva mental stuff.
Key exclusion criteria (4 listed)
- Without any neurological or head trauma.
- Without alcohol or substance abuse.
- No evidence of psychotic episode in there history.
- Stable doses of different specific serotonin reuptake inhibitors (SSRI) antidepressant for at least two months.
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 7 Nov 2012.
Related trials for Post-Traumatic Stress Disorder
Not yet recruiting
The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veterans
Alcohol Problems, Post-Traumatic Stress Disorder
RecruitingPhase 3
An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
Post Traumatic Stress Disorder
Active, not recruitingObservational study
Trauma-Related Attributions in Trauma Treatment: An Observational Study
PTSD
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
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 Post-Traumatic Stress Disorder, run by Beersheva Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2012. 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 Israel. 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?
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 7 Nov 2012.