RuminationNCT06748976
Modulation of Cortical Brain Activity During Attentional Control
An observational study of Rumination and Chronic Pain, run by National Council of Scientific and Technical Research, Argentina at 1 site in Argentina.
Trial summary
The goal of this study is to determine whether an open-loop sham neurofeedback system can effectively modulate EEG alpha rhythms, which are associated with attentional control. The main questions it aims to answer are: Does positive sham neurofeedback lead to a decrease in relative EEG alpha power compared to a… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rumination, Chronic Pain, Fibromyalgia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jul 2025to Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study will include adults aged between 18 and 60 years, selected from the city of Paraná and surrounding areas. The population will be balanced in terms of age and gender, ensuring representation across two age groups (18-40 years and 41-60 years). Participants will be recruited through: * Word-of-mouth. * Social media platforms. * University mailing lists and community boards. Initial contact will be made via telephone or email, where potential participants will be provided with detailed information about the study's purpose, procedures, and eligibility criteria. Recruitment materials and communications will describe the study as a conventional neurofeedback experiment to maintain participant naivety about the specific hypotheses and experimental conditions.
Who may be able to join
- Adults aged between 18 and 60 years.
- Normal or corrected vision.
- Ability to provide written informed consent.
Who cannot join
- Diagnosed with photosensitive epilepsy.
- Significant hearing loss or diagnosed hearing impairment.
- Current psychiatric illness or disorder.
- History of migraines or chronic headaches.
- History of substance or alcohol abuse.
- Currently pregnant.
- Discomfort with using a virtual reality headset, assessed during a pilot session.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site, 1 recruiting
- Recruiting
Facultad de Ingeniería, Universidad Nacional de Entre Ríos
Oro Verde, Entre Ríos Province, 3100
José Alberto Biurrun Manresa, PhD, +543434975100, jose.biurrun@uner.edu.ar
José Alberto Biurrun Manresa, PhD
About this study
Official title: EEG Alpha Rhythm Modulation Using Sham Neurofeedback During Attentional Control in a Virtual Reality Environment
The goal of this study is to determine whether an open-loop sham neurofeedback system can effectively modulate EEG alpha rhythms, which are associated with attentional control. The main questions it aims to answer are:
Does positive sham neurofeedback lead to a decrease in relative EEG alpha power compared to a control condition without feedback?
Read more
Researchers will compare the effects of positive and negative sham-neurofeedback conditions to a control condition without feedback to assess the system's impact on alpha rhythm modulation. Participants will:
Experience three conditions (positive sham-neurofeedback, negative sham-neurofeedback, and no feedback) within a virtual reality environment.
Undergo EEG recordings to measure changes in alpha power as a marker of attentional resource allocation.
Provide written informed consent and complete the study following ethical guidelines.
This study seeks to explore the potential of open-loop feedback systems to enhance attentional control by modulating alpha rhythm.
Read the detailed description
Attention is a vital cognitive process that enables selective focus on behaviourally relevant information. A perceived lack of attentional control has been linked to mental disorders such as depression and anxiety, often manifesting through maladaptive coping strategies like rumination. As a trainable cognitive skill, attentional control can be enhanced through learning processes, particularly when reinforced by positive feedback within a classical operant conditioning framework. EEG studies have demonstrated that decreases in alpha rhythm power are associated with increased attentional resource allocation. While neurofeedback systems, especially those targeting alpha rhythms, typically rely on closed-loop modulation during attentional tasks, the impact of open-loop feedback on EEG alpha modulation remains unexplored. This study aims to determine whether an open-loop feedback system can effectively modulate EEG alpha rhythms, as a marker correlate of attentional control. The investigators propose a within-subject experiment where participants will experience positive and negative sham neurofeedback conditions, as well as a control condition with no feedback, all within a virtual reality environment. The investigators hypothesize that relative EEG alpha power will decrease in the positive sham neurofeedback condition compared to the control condition, reflecting a meaningful increase in attentional resource allocation.
- Conditions
- Rumination, Chronic Pain, Fibromyalgia
- Being tested
- Positive sham neurofeedback, Negative sham neurofeedback, Control
- Keywords
- operant conditioning, rumination, metacognition, neurofeedback, selective attention
- Medical subject headings
- Rumination Syndrome, Chronic Pain, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive sham neurofeedbackOther
Participants receive simulated positive reinforcement feedback designed to mimic successful modulation of EEG alpha rhythms, despite the feedback not being directly based on their actual neural activity. This condition aims to create the perception of improved attentional control.
Negative sham neurofeedbackOther
Participants receive simulated negative reinforcement feedback that mimics unsuccessful modulation of EEG alpha rhythms, regardless of their actual neural activity. This condition is intended to simulate reduced attentional control.
ControlOther
Participants perform the same attentional task but without receiving any feedback. This condition serves as a baseline to evaluate the effects of the sham neurofeedback interventions on EEG alpha rhythm modulation.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Volunteers: Adults aged 18-60 years with normal or corrected vision, no clinical history of photosensitive epilepsy, psychiatric disorders, significant hearing loss, migraines, or substance abuse.
Interventions:
Positive sham-neurofeedback Negative sham-neurofeedback Control (no feedback) Receives: Other: Positive sham neurofeedback; Other: Negative sham neurofeedback; Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative alpha power
The primary outcome of the study is the change in relative EEG alpha power during the positive sham-neurofeedback condition compared to the control condition (no feedback). A decrease in relative alpha power is interpreted as an indicator of increased attentional resource allocation, reflecting enhanced attentional control. This measure is derived from EEG recordings captured during the experimental tasks in each condition.
Measured: Immediately after intervention
Secondary outcomes (1)
Relative alpha power
The secondary outcome of the study is the change in relative EEG alpha power during the negative sham-neurofeedback condition compared to the control condition (no feedback).
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Jul 2025
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
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 RuminationStudies 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Council of Scientific and Technical Research, Argentina
- Sponsor type
- Other government
- Responsible party
- Principal investigator, José Biurrun Manresa, National Council of Scientific and Technical Research, Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748976
- Sponsor's protocol ID
- IS004817
- Status last verified
- Sep 2025
- First submitted
- 19 Dec 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be made available on the 'Open Science Framework' after undergoing the process of anonymization to remove any participant-identifying information. The data will consist of the raw EEG signals and raw behavioral responses. Additionally, the statistical analysis and Python notebooks used to process the data will also be shared
Publications
Knowles MM, Wells A. Single Dose of the Attention Training Technique Increases Resting Alpha and Beta-Oscillations in Frontoparietal Brain Networks: A Randomized Controlled Comparison. Front Psychol. 2018 Sep 20;9:1768. doi: 10.3389/fpsyg.2018.01768. eCollection 2018.
PubMed 30294294Magosso E, Ricci G, Ursino M. Modulation of brain alpha rhythm and heart rate variability by attention-related mechanisms. AIMS Neurosci. 2019 Mar 4;6(1):1-24. doi: 10.3934/Neuroscience.2019.1.1. eCollection 2019.
PubMed 32341965Enriquez-Geppert S, Smit D, Pimenta MG, Arns M. Neurofeedback as a Treatment Intervention in ADHD: Current Evidence and Practice. Curr Psychiatry Rep. 2019 May 28;21(6):46. doi: 10.1007/s11920-019-1021-4.
PubMed 31139966
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG Alpha Rhythm Modulation Using Sham Neurofeedback During Attentional Control in a Virtual Reality Environment
- ClinicalTrials.gov ID
- NCT06748976
- Acronym / sponsor ID
- IS004817
- Conditions
- Rumination, Chronic Pain, Fibromyalgia
- Keywords
- operant conditioning, rumination, metacognition, neurofeedback, selective attention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- National Council of Scientific and Technical Research, ArgentinaOther government
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 27 Dec 2024 (actual)
- 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.
The goal of this study is to determine whether an open-loop sham neurofeedback system can effectively modulate EEG alpha rhythms, which are associated with attentional control. The main questions it aims to answer are:
Does positive sham neurofeedback lead to a decrease in relative EEG alpha power compared to a control condition without feedback?
Researchers will compare the effects of positive and negative sham-neurofeedback conditions to a control condition without feedback to assess the system's impact on alpha rhythm modulation. Participants will:
Experience three conditions (positive sham-neurofeedback, negative sham-neurofeedback, and no feedback) within a virtual reality environment.
Undergo EEG recordings to measure changes in alpha power as a marker of attentional resource allocation.
Provide written informed consent and complete the study following ethical guidelines.
This study seeks to explore the potential of open-loop feedback systems to enhance attentional control by modulating alpha rhythm.
Detailed description
Attention is a vital cognitive process that enables selective focus on behaviourally relevant information. A perceived lack of attentional control has been linked to mental disorders such as depression and anxiety, often manifesting through maladaptive coping strategies like rumination. As a trainable cognitive skill, attentional control can be enhanced through learning processes, particularly when reinforced by positive feedback within a classical operant conditioning framework. EEG studies have demonstrated that decreases in alpha rhythm power are associated with increased attentional resource allocation. While neurofeedback systems, especially those targeting alpha rhythms, typically rely on closed-loop modulation during attentional tasks, the impact of open-loop feedback on EEG alpha modulation remains unexplored. This study aims to determine whether an open-loop feedback system can effectively modulate EEG alpha rhythms, as a marker correlate of attentional control. The investigators propose a within-subject experiment where participants will experience positive and negative sham neurofeedback conditions, as well as a control condition with no feedback, all within a virtual reality environment. The investigators hypothesize that relative EEG alpha power will decrease in the positive sham neurofeedback condition compared to the control condition, reflecting a meaningful increase in attentional resource allocation.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Other: Positive sham neurofeedback, Other: Negative sham neurofeedback, Other: ControlVolunteers: Adults aged 18-60 years with normal or corrected vision, no clinical history of photosensitive epilepsy, psychiatric disorders, significant hearing loss, migraines, or substance abuse. Interventions: Positive sham-neurofeedback Negative sham-neurofeedback Control (no feedback) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will include adults aged between 18 and 60 years, selected from the city of Paraná and surrounding areas. The population will be balanced in terms of age and gender, ensuring representation across two age groups (18-40 years and 41-60 years). Participants will be recruited through: * Word-of-mouth. * Social media platforms. * University mailing lists and community boards. Initial contact will be made via telephone or email, where potential participants will be provided with detailed information about the study's purpose, procedures, and eligibility criteria. Recruitment materials and communications will describe the study as a conventional neurofeedback experiment to maintain participant naivety about the specific hypotheses and experimental conditions.
Key inclusion criteria (3 listed)
- Adults aged between 18 and 60 years.
- Normal or corrected vision.
- Ability to provide written informed consent.
Key exclusion criteria (7 listed)
- Diagnosed with photosensitive epilepsy.
- Significant hearing loss or diagnosed hearing impairment.
- Current psychiatric illness or disorder.
- History of migraines or chronic headaches.
- History of substance or alcohol abuse.
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 |
|---|---|---|
| Positive sham neurofeedbackParticipants receive simulated positive reinforcement feedback designed to mimic successful modulation of EEG alpha rhythms, despite the feedback not being directly based on their actual neural activity. This condition aims to create the perception of improved attentional control. | Other | Healthy |
| Negative sham neurofeedbackParticipants receive simulated negative reinforcement feedback that mimics unsuccessful modulation of EEG alpha rhythms, regardless of their actual neural activity. This condition is intended to simulate reduced attentional control. | Other | Healthy |
| ControlParticipants perform the same attentional task but without receiving any feedback. This condition serves as a baseline to evaluate the effects of the sham neurofeedback interventions on EEG alpha rhythm modulation. | Other | Healthy |
Primary outcome
Relative alpha power
Time frame: Immediately after intervention
The primary outcome of the study is the change in relative EEG alpha power during the positive sham-neurofeedback condition compared to the control condition (no feedback). A decrease in relative alpha power is interpreted as an indicator of increased attentional resource allocation, reflecting enhanced attentional control. This measure is derived from EEG recordings captured during the experimental tasks in each condition.
1 secondary outcome
Relative alpha power
Time frame: Immediately after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Background: PubMed 30294294Knowles MM, Wells A. Single Dose of the Attention Training Technique Increases Resting Alpha and Beta-Oscillations in Frontoparietal Brain Networks: A Randomized Controlled Comparison. Front Psychol. 2018 Sep 20;9:1768. doi: 10.3389/fpsyg.2018.01768. eCollection 2018.
- Background: PubMed 32341965Magosso E, Ricci G, Ursino M. Modulation of brain alpha rhythm and heart rate variability by attention-related mechanisms. AIMS Neurosci. 2019 Mar 4;6(1):1-24. doi: 10.3934/Neuroscience.2019.1.1. eCollection 2019.
- Background: PubMed 31139966Enriquez-Geppert S, Smit D, Pimenta MG, Arns M. Neurofeedback as a Treatment Intervention in ADHD: Current Evidence and Practice. Curr Psychiatry Rep. 2019 May 28;21(6):46. doi: 10.1007/s11920-019-1021-4.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be made available on the 'Open Science Framework' after undergoing the process of anonymization to remove any participant-identifying information. The data will consist of the raw EEG signals and raw behavioral responses. Additionally, the statistical analysis and Python notebooks used to process the data will also be shared
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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.
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 Rumination and Chronic Pain, run by National Council of Scientific and Technical Research, Argentina at 1 site in Argentina.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 25 Sep 2025. 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 Argentina. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact José Alberto Biurrun Manresa, PhD (+543434975100120, jose.biurrun@uner.edu.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative alpha power (time frame: Immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06748976, 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 25 Sep 2025; AzTrials last refreshed its copy on 31 Oct 2026.