StressNCT02020265
fMRI Based EEG Neurofeedback as a Method of Enhancing Emotional Resilience Among Soldiers
A study testing EEG neurofeedback in people with Stress and Depression, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
EEG protocols exist for reducing stress and improve PTSD symptoms (A/T EEG protocols, Peniston, 1993, Hammond, 2005) however; our innovative EEG-NF LMI approach intends to be more amygdala/stress specific and therefore more efficient. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Depression
- What is being tested?
- EEG neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2013to Dec 2020
- Phase
- Interventional
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- soldiers in preliminary combat training
Who cannot join
- known mental disorders or neuro-pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Study of the Effect of Neurofeedback Training on Soldiers Emotional Regulation Ability and Mental Resilience to Stress.
EEG protocols exist for reducing stress and improve PTSD symptoms (A/T EEG protocols, Peniston, 1993, Hammond, 2005) however; our innovative EEG-NF LMI approach intends to be more amygdala/stress specific and therefore more efficient. Three groups of soldiers, while in operational activity will go through 24 sessions of 3 different methods of EEG-NF; our newly developed NF via MLI, a standard procedure for NF via A/T and a placebo NF. Difference between the groups in regard to their emotion regulation capability will be tested by fMRI with regard to amygdala activation following EEG-NF LMI as well as two stress challenge tests.
- Conditions
- Stress, Depression
- Being tested
- EEG neurofeedback
- Keywords
- stress and depression related symptoms
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG neurofeedbackDevice
| Study group | Role | What they receive |
|---|---|---|
| NF group | Experimental | This group will train modulation of the amygdala EEG fingerprint by EEG neurofeedback. Receives: Device: EEG neurofeedback |
| Sham NF | Sham comparator | This group preform the same procedure as the NF group only reviving sham feedback Receives: Device: EEG neurofeedback |
| A\T NF | Active comparator | This group will train modulation of A\T ratio by EEG neurofeedback Receives: Device: EEG neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline at Amygdala modulation ability
The test group will show a grater improvment from baseline in amygdala modulation abilities as measured by real time fMRI
Measured: At baseline and after 6 month of neurofeeback training.
Secondary outcomes (1)
Change from baseline in Emotion regulation ability
The test group will show grater improvement from baseline of emotion regulation abilities as measured by implicit and explicit test and by fMRI
Measured: At baseline and after 6 month of neurofeedback training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020265
- Sponsor's protocol ID
- 0080-13
- Status last verified
- Sep 2018
- First submitted
- 12 Nov 2013
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of the Effect of Neurofeedback Training on Soldiers Emotional Regulation Ability and Mental Resilience to Stress.
- ClinicalTrials.gov ID
- NCT02020265
- Acronym / sponsor ID
- 0080-13
- Conditions
- Stress, Depression
- Keywords
- stress and depression related symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Feb 2013
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 24 Dec 2013 (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.
EEG protocols exist for reducing stress and improve PTSD symptoms (A/T EEG protocols, Peniston, 1993, Hammond, 2005) however; our innovative EEG-NF LMI approach intends to be more amygdala/stress specific and therefore more efficient. Three groups of soldiers, while in operational activity will go through 24 sessions of 3 different methods of EEG-NF; our newly developed NF via MLI, a standard procedure for NF via A/T and a placebo NF. Difference between the groups in regard to their emotion regulation capability will be tested by fMRI with regard to amygdala activation following EEG-NF LMI as well as two stress challenge tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NF group | Experimental | Device: EEG neurofeedbackThis group will train modulation of the amygdala EEG fingerprint by EEG neurofeedback. |
| Sham NF | Sham comparator | Device: EEG neurofeedbackThis group preform the same procedure as the NF group only reviving sham feedback |
| A\T NF | Active comparator | Device: EEG neurofeedbackThis group will train modulation of A\T ratio by EEG neurofeedback |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- soldiers in preliminary combat training
Key exclusion criteria (1 listed)
- known mental disorders or neuro-pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG neurofeedback | Device | A\T NF, NF group, Sham NF |
Primary outcome
Change from baseline at Amygdala modulation ability
Time frame: At baseline and after 6 month of neurofeeback training.
The test group will show a grater improvment from baseline in amygdala modulation abilities as measured by real time fMRI
1 secondary outcome
Change from baseline in Emotion regulation ability
Time frame: At baseline and after 6 month of neurofeedback training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
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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?
A study testing EEG neurofeedback in people with Stress and Depression, run by Tel-Aviv Sourasky Medical 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Sep 2018. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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.
What does the primary outcome measure?
Change from baseline at Amygdala modulation ability (time frame: At baseline and after 6 month of neurofeeback training.). It is what the study was designed to measure, not a finding.
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 25 Sep 2018.