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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Israel1 site
  • Beer Sheva Mental Health Center

    Beersheba

Other trials in Israel

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).

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 groups in NCT01020695
Study groupRoleWhat they receive
PTSD veterans18 PTSD veterans
controls20 controls

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionNov 2009
  4. Study completionNov 2009

Resources

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)
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

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.

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