DepressionNCT01945372
Neurofeedback Treatment of Affective Instability in Premenstrual Dysphoric Disorder(PMDD)
A study testing EEG NeuroFeedback in people with Depression and Premenstrual Dysphoric Disorder (PMDD), run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Premenstrual Dysphoric Disorder (PMDD) is characterized by affective instability and irritability, diagnosed in 5% of reproductive-age women. Although causing severe insult to patients' functioning and quality of life, ~40% do not respond to conventional treatment options. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Depression, Premenstrual Dysphoric Disorder (PMDD)
- What is being tested?
- EEG NeuroFeedback
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2013to Aug 2019
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Current pregnancy or breastfeeding
- Women using an oral contraceptive or a hormonal IUD.
- Current anti-depressant pharmacological treatment.
- Meet at admission axis I DSM IV diagnosis. for a current major depressive episode or a psychotic disorder.
- Substance dependence or abuse other than nicotine in the 30 days prior to screening.
- Patients with an acute or chronic condition that might be harmed by the proposed treatment according to the judgment of the clinical Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-modulation of Prefrontal Alpha Asymmetry:Novel Neurofeedback Treatment of Affective Instability in Premenstrual Dysphoric Disorder(PMDD)
Premenstrual Dysphoric Disorder (PMDD) is characterized by affective instability and irritability, diagnosed in 5% of reproductive-age women. Although causing severe insult to patients' functioning and quality of life, ~40% do not respond to conventional treatment options.
In this study, the investigators aim to examine a novel therapeutic approach for the treatment of affective instability in PMDD: brain-guided training (i.e.NeuroFeedBack, NF) probed by prefrontal EEG alpha asymmetry. PMDD patients will be randomly assigned to either a real or sham EEG-NF protocol, and undergo simultaneous fMRI-EEG scans before and after training period. Comprehensive psychological assessment will be performed for outcome measure. The investigators hypothesize that EEG-NF treatment will enhance affective stability, thus improving patients' daily lives.
Read the detailed description
Epidemiological and clinical studies consistently show that approximately 2-8% of all premenopausal women suffer from premenstrual dysphoric disorder (PMDD) - a serious pattern of distressing symptoms beginning at the luteal phase of the menstrual cycle and terminating shortly after the onset of menses. The most common psychological symptoms reported by women with PMDD are mood lability and irritability, and to a lesser extent a depressed mood or diminished interest and pleasure. In contrast to the milder premenstrual syndrome (PMS), PMDD is a severe mental disorder which can in some cases even trigger suicidal thoughts and attempts. Sadly, many women do not respond to currently available pharmacological treatments, while others suffer from their side effects throughout the month.
The proposed study aims to examine the clinical effectiveness of a novel therapeutic approach for treating emotional instability in PMDD. The investigators plan to use a clinical model of weekly brain-guided training (i.e. NeuroFeedBack, NF) to gain better self control of affect and its regulation. Feedback will be based on modulating pre-frontal EEG Alpha waves, a technique shown in prior studies to have a therapeutic effect in affective symptoms; however the brain circuitry which underlies such effects is largely unknown. By using simultaneous fMRI and EEG the investigators intend to unveil the neural correlates of response to such treatment and to provide new markers for clinical trajectory in PMDD.
Prospectively diagnosed PMDD women will be randomly assigned to either a real or sham EEG-NF protocol. During the training, patients will be instructed to "Think Positively" in order to actively manipulate brain areas that are related to positive experiences, while viewing a stream of various faces with different expressions. Following each facial image, feedback based on the alpha asymmetry score will be given to the patient regarding their ability to generate positive thoughts during the stream of faces. However, only the women within study group will receive accurate feedback. To obtain a neural and hormonal profile, patients will undergo simultaneous EEG-fMRI testing before and after training, and blood samples of hormone levels will be gathered. Comprehensive psychiatric and psychological assessment will be performed as an outcome measure.
The investigators hypothesize that the NF protocol will enhance affective stability, thus improving daily functioning and quality of life among PMDD patients, without the need for pharmacological agents, intrusive techniques or time consuming interventions. Moreover, this treatment method is individually tailored to the needs and symptoms of the patient and can be used periodically rather than continuously. The patient remains in control throughout the procedure, and can potentially learn to use this technique on a continuous basis, beyond the scope of the clinical trial.
- Conditions
- Depression, Premenstrual Dysphoric Disorder (PMDD)
- Being tested
- EEG NeuroFeedback
- Medical subject headings
- Depression, Premenstrual Dysphoric Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG NeuroFeedbackOther
| Study group | Role | What they receive |
|---|---|---|
| EEG NeuroFeedback - real feedback | Experimental | Thw women in the experimental group will receive accurate realtime feedback corresponding to their performance on the task. Receives: Other: EEG NeuroFeedback |
| EEG NeuroFeedback - sham feedback | Sham comparator | The women in the sham group will receive neural feedback from another person in the study, thus unrelated to their mental practice Receives: Other: EEG NeuroFeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
PMDD symptoms
Will be assessed by the score on the PMTS questionnaire before, during and after the intervention.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 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
- NCT01945372
- Sponsor's protocol ID
- TASMC-13-TH-0295-13-CTIL
- Status last verified
- Sep 2013
- First submitted
- 8 Sep 2013
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-modulation of Prefrontal Alpha Asymmetry:Novel Neurofeedback Treatment of Affective Instability in Premenstrual Dysphoric Disorder(PMDD)
- ClinicalTrials.gov ID
- NCT01945372
- Acronym / sponsor ID
- TASMC-13-TH-0295-13-CTIL
- Conditions
- Depression, Premenstrual Dysphoric Disorder (PMDD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Oct 2013 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 18 Sep 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.
Premenstrual Dysphoric Disorder (PMDD) is characterized by affective instability and irritability, diagnosed in 5% of reproductive-age women. Although causing severe insult to patients' functioning and quality of life, ~40% do not respond to conventional treatment options.
In this study, the investigators aim to examine a novel therapeutic approach for the treatment of affective instability in PMDD: brain-guided training (i.e.NeuroFeedBack, NF) probed by prefrontal EEG alpha asymmetry. PMDD patients will be randomly assigned to either a real or sham EEG-NF protocol, and undergo simultaneous fMRI-EEG scans before and after training period. Comprehensive psychological assessment will be performed for outcome measure. The investigators hypothesize that EEG-NF treatment will enhance affective stability, thus improving patients' daily lives.
Detailed description
Epidemiological and clinical studies consistently show that approximately 2-8% of all premenopausal women suffer from premenstrual dysphoric disorder (PMDD) - a serious pattern of distressing symptoms beginning at the luteal phase of the menstrual cycle and terminating shortly after the onset of menses. The most common psychological symptoms reported by women with PMDD are mood lability and irritability, and to a lesser extent a depressed mood or diminished interest and pleasure. In contrast to the milder premenstrual syndrome (PMS), PMDD is a severe mental disorder which can in some cases even trigger suicidal thoughts and attempts. Sadly, many women do not respond to currently available pharmacological treatments, while others suffer from their side effects throughout the month.
The proposed study aims to examine the clinical effectiveness of a novel therapeutic approach for treating emotional instability in PMDD. The investigators plan to use a clinical model of weekly brain-guided training (i.e. NeuroFeedBack, NF) to gain better self control of affect and its regulation. Feedback will be based on modulating pre-frontal EEG Alpha waves, a technique shown in prior studies to have a therapeutic effect in affective symptoms; however the brain circuitry which underlies such effects is largely unknown. By using simultaneous fMRI and EEG the investigators intend to unveil the neural correlates of response to such treatment and to provide new markers for clinical trajectory in PMDD.
Prospectively diagnosed PMDD women will be randomly assigned to either a real or sham EEG-NF protocol. During the training, patients will be instructed to "Think Positively" in order to actively manipulate brain areas that are related to positive experiences, while viewing a stream of various faces with different expressions. Following each facial image, feedback based on the alpha asymmetry score will be given to the patient regarding their ability to generate positive thoughts during the stream of faces. However, only the women within study group will receive accurate feedback. To obtain a neural and hormonal profile, patients will undergo simultaneous EEG-fMRI testing before and after training, and blood samples of hormone levels will be gathered. Comprehensive psychiatric and psychological assessment will be performed as an outcome measure.
The investigators hypothesize that the NF protocol will enhance affective stability, thus improving daily functioning and quality of life among PMDD patients, without the need for pharmacological agents, intrusive techniques or time consuming interventions. Moreover, this treatment method is individually tailored to the needs and symptoms of the patient and can be used periodically rather than continuously. The patient remains in control throughout the procedure, and can potentially learn to use this technique on a continuous basis, beyond the scope of the clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EEG NeuroFeedback - real feedback | Experimental | Other: EEG NeuroFeedbackThw women in the experimental group will receive accurate realtime feedback corresponding to their performance on the task. |
| EEG NeuroFeedback - sham feedback | Sham comparator | Other: EEG NeuroFeedbackThe women in the sham group will receive neural feedback from another person in the study, thus unrelated to their mental practice |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Current pregnancy or breastfeeding
- Women using an oral contraceptive or a hormonal IUD.
- Current anti-depressant pharmacological treatment.
- Meet at admission axis I DSM IV diagnosis. for a current major depressive episode or a psychotic disorder.
- Substance dependence or abuse other than nicotine in the 30 days prior to screening.
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 | Other | EEG NeuroFeedback - real feedback, EEG NeuroFeedback - sham feedback |
Primary outcome
PMDD symptoms
Time frame: Up to 24 months
Will be assessed by the score on the PMTS questionnaire before, during and after the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 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 Depression and Premenstrual Dysphoric Disorder (PMDD), 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 0 inclusion and 6 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 16 Mar 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?
PMDD symptoms (time frame: Up to 24 months). 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 16 Mar 2018.