- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07745335
AVE-Neurofeedback for Academic Anxiety and Divergent Thinking (AVE-NFB)
Efficacy of a Multisensory Audiovisual Entrainment Neurofeedback for Academic Anxiety Regulation and Divergent Thinking: A Randomized Controlled Trial Study
Academic anxiety is one of the most prevalent psychological challenges among adolescents and has been associated with impaired executive functioning, attentional control, autonomic dysregulation, and reduced creative performance. Although neurofeedback and audiovisual entrainment have independently demonstrated beneficial effects on neural self-regulation, evidence regarding their integration within an adaptive closed-loop intervention remains limited.
This multicenter, parallel-group, randomized controlled trial aims to evaluate the efficacy of an Audiovisual Entrainment Neurofeedback (AVE-NFB) system for improving neural self-regulation, reducing academic anxiety, enhancing autonomic regulation, and promoting divergent thinking among senior high school students. A total of 240 participants recruited from two school centers will be randomly allocated to one of four intervention groups: Combined AVE-Neurofeedback, Neurofeedback Only, Audiovisual Entrainment Only, or Sham Control.
Each participant will complete 12 intervention sessions over a six-week intervention period (administered twice weekly). During every session, brain activity will be continuously acquired using the Emotiv Epoc X 14-channel research-grade electroencephalography (EEG) headset (256 Hz sampling rate). Following a standardized 5-minute resting calibration (3 minutes eyes closed and 2 minutes eyes open), the system will estimate each participant's individualized resting alpha activity (8-12 Hz). The neurofeedback engine continuously monitors alpha-band power from the multi-channel frontal (AF3, F7, F3, FC5, FC6, F4, F8, AF4) and temporoparietal (T7, P7, T8, P8) electrodes. Positive audiovisual reinforcement is automatically activated whenever the participant maintains alpha power above the individualized reinforcement threshold for at least 2 seconds while satisfying artifact-quality criteria. Reinforcement is automatically attenuated or suspended whenever alpha activity falls below the threshold or excessive ocular or motion artifacts are detected, thereby establishing a fully adaptive closed-loop reinforcement process based on operant conditioning principles.
Outcome assessments will be performed at baseline, immediately after completion of the intervention, one week after the intervention, and one month after the intervention. Primary neural outcomes will include resting-state absolute alpha power measured using the Emotiv Epoc X 14-channel EEG. Secondary outcomes will include academic anxiety assessed using the Spielberger Test Anxiety Inventory (TAI), autonomic regulation assessed using Heart Rate Variability using the Root Mean Square of Successive Differences (RMSSD), and divergent thinking assessed using the Alternative Uses Task (AUT).
Study Overview
Status
Conditions
Detailed Description
Background Academic anxiety is a major psychological concern among adolescents and has consistently been associated with impaired executive functioning, attentional control, emotional regulation, autonomic imbalance, and reduced creative cognition. Neurophysiological evidence indicates that these impairments are accompanied by dysregulated cortical alpha oscillations and reduced parasympathetic nervous system activity. Neurofeedback enables individuals to voluntarily regulate neural oscillatory activity through real-time electroencephalographic feedback, whereas audiovisual entrainment facilitates neural synchronization using rhythmic photic stimulation and binaural auditory stimulation. Despite encouraging evidence supporting each intervention independently, limited research has investigated their integration within an adaptive closed-loop neurofeedback architecture capable of delivering individualized reinforcement based on ongoing neural activity.
Objectives The primary objective of this study is to determine whether an Audiovisual Entrainment Neurofeedback (AVE-NFB) system produces greater increases in resting-state absolute alpha-band power than isolated neurofeedback, isolated audiovisual entrainment, or sham intervention.Secondary objectives are to evaluate changes in academic anxiety, autonomic nervous system regulation, divergent thinking, and the durability of treatment effects during one-week and one-month follow-up assessments.
Study Design This study is a multicenter, four-arm, parallel-group, randomized controlled trial involving 240 participants recruited from two senior high school centers. Participants will be randomly assigned to one of four intervention groups: (1) Combined AVE-Neurofeedback; (2) Neurofeedback Only; (3); Audiovisual Entrainment Only & (4) Sham Control. Each participant will complete 12 intervention sessions across a six-week period (administered twice weekly). Outcome assessments will be conducted at: (1) Baseline (Week 0); (2) Immediately Post-intervention (Week 6); (3) One-week Follow-up (Week 7); (4) One-month Follow-up (Week 10)
Closed-Loop Neurofeedback Mechanism The Audiovisual Entrainment Neurofeedback (AVE-NFB) employs a fully adaptive closed-loop brain-computer interface integrating real-time EEG monitoring with synchronized audiovisual entrainment.EEG signals are continuously acquired using the Emotiv Epoc X 14-channel research-grade EEG headset at a sampling frequency of 256 Hz from saline-based electrodes positioned at AF3, F7, F3, FC5, T7, P7, O1, O2, P8, T8, FC6, F4, F8, and AF4, mapped according to the International 10-20 system. Each intervention session begins with a standardized 5-minute calibration period consisting of 3 minutes of eyes-closed resting state followed by 2 minutes of eyes-open resting state. Calibration data are used to establish each participant's individualized resting absolute alpha-band activity (8-12 Hz).During neurofeedback training, EEG signals undergo automated quality control, including artifact detection for eye blinks, excessive movement, and poor electrode contact across all 14 channels. Only artifact-free epochs are processed for online estimation of absolute alpha-band power using short overlapping analysis windows averaged across the frontal and temporoparietal regions of interest.The individualized reinforcement threshold is initialized at 110% of the participant's median resting absolute alpha power obtained during calibration. Throughout each training session, this threshold is dynamically adjusted by a physiological controller driven by rolling Heart Rate Variability (RMSSD) estimates. Positive reinforcement is delivered only when alpha power remains continuously above this adaptive threshold for at least 2 consecutive seconds while signal quality satisfies predefined artifact acceptance criteria.
Successful threshold attainment automatically activates synchronized audiovisual reinforcement consisting of: (1) Alpha-frequency rhythmic photic stimulation; (2) Binaural beat auditory stimulation centered within the alpha range; (3) Non-directive relaxation guidance & (4) Continuous visual performance feedback. Whenever alpha activity decreases below the reinforcement threshold or excessive artifacts are detected, audiovisual reinforcement is immediately attenuated or suspended until stable neural activity resumes. This adaptive reinforcement paradigm is designed to strengthen voluntary alpha self-regulation through operant conditioning rather than passive sensory stimulation.
Throughout each session, the system automatically records continuous 14-channel EEG signals, artifact events, individualized threshold values, reinforcement activation duration, cumulative reinforcement time, session performance indices, and event timestamps for subsequent offline verification and statistical analysis.
Outcome Measures Primary Outcome Resting-State Absolute Alpha Power (8-12 Hz) measured via spectral analysis using the Emotiv Epoc X 14-channel EEG headset.
Secondary Outcomes Academic anxiety assessed using the Spielberger Test Anxiety Inventory (TAI). Autonomic nervous system regulation assessed using Heart Rate Variability (RMSSD). Divergent thinking assessed using the Alternative Uses Task (AUT), including fluency, flexibility, originality, and elaboration scores.
Power Analysis An a priori power analysis indicates that a total sample size of N = 240 (n = 60 per arm) provides over 80% statistical power to detect a small-to-medium interaction effect size (f = 0.20) in a longitudinal repeated-measures design with four groups and four timepoints, assuming a conservative 15% attrition rate and an alpha level of 0.05.
Statistical Analysis Longitudinal repeated-measures data will be analyzed using Linear Mixed-Effects Models (LMM). Treatment group, assessment time, and the group-by-time interaction will be specified as fixed effects, whereas participant-specific random intercepts will account for within-subject dependency. School center, circadian assessment phase, and intervention session timing will be incorporated as predefined covariates. The LMM framework was selected because it appropriately accommodates repeated measurements, multicenter clustering, and incomplete follow-up observations under the missing-at-random assumption while preserving statistical efficiency.
Expected Significance This study is expected to provide rigorous evidence regarding the efficacy of adaptive closed-loop multisensory neurofeedback for improving cortical alpha self-regulation, reducing academic anxiety, enhancing autonomic nervous system function, and promoting divergent thinking among adolescents. The findings may contribute to the development of scalable, neuroscience-based, non-pharmacological interventions for school mental health and cognitive enhancement.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Daniswara Raditya Suprapto
- Phone Number: +6289502459696
- Email: daniswara.raditya144@sma.belajar.id
Study Contact Backup
- Name: Navysa Fatah Onawa
- Phone Number: +6281252278367
- Email: 2411464@magelang.tarunanusantara.sch.id
Study Locations
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Central Java
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Magelang, Central Java, Indonesia, 56172
- Not yet recruiting
- SMA Taruna Nusantara
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Contact:
- Susilo Tri Atmojo, S.Si
- Phone Number: +62 858-7932-7398
- Email: susilotn.35@gmail.com
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East Java
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Nganjuk, East Java, Indonesia, 64415
- Recruiting
- Rumah Sakit Daerah (RSD) Nganjuk
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Contact:
- Ridha Yustiana
- Phone Number: +62 858-5575-4690
- Email: infoyan@rsd.nganjukkab.go.id
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Nganjuk, East Java, Indonesia, 64415
- Not yet recruiting
- SMA Negeri 1 Nganjuk
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Contact:
- Finiswatin S.Pd., M.Pd, Master
- Phone Number: +6281235088880
- Email: smasa_nganjuk@yahoo.co.id
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Senior high school students aged 15-18 years.
- Elevated academic anxiety according to screening assessment.
- Able to understand study procedures.
- Willing to provide written informed consent (and parental consent where required).
Exclusion Criteria:
- History of epilepsy or seizure disorders.
- Neurological disorders.
- Severe psychiatric disorders.
- Current psychoactive medication affecting EEG activity.
- Significant visual impairment incompatible with photic stimulation.
- Previous neurofeedback training within the last six months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Audiovisual Entrainment Only
Participants will receive standardized alpha-frequency audiovisual entrainment consisting of rhythmic photic stimulation, binaural beat auditory stimulation, and non-directive relaxation guidance.
The intervention will be delivered without EEG neurofeedback, HRV-guided adaptation, or individualized physiological feedback.
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Participants will receive standardized alpha-frequency audiovisual entrainment consisting of rhythmic photic stimulation, binaural beat auditory stimulation, and standardized non-directive relaxation guidance.
Stimulation parameters will remain fixed throughout each session without EEG acquisition, HRV biofeedback, individualized threshold adaptation, or brain-state-dependent reinforcement.
Participants will complete 12 intervention sessions over approximately 6 weeks.
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Experimental: Audiovisual Entrainment Neurofeedback (AVE-NFB)
Participants will receive adaptive multimodal Audiovisual Entrainment Neurofeedback (AVE-NFB) integrating real-time EEG neurofeedback, heart rate variability (HRV)-guided adaptive thresholding, alpha-frequency photic stimulation, binaural beat auditory stimulation, non-directive relaxation guidance, and visual neurofeedback using the Emotiv Epoc X.
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Participants will receive 12 Session of an Audiovisual Entrainment Neurofeedback (AVE-NFB) intervention integrating real-time electroencephalography (EEG) and heart rate variability (HRV) biofeedback.
Neural activity will be continuously acquired using the Emotiv Epoc X EEG, while cardiac activity will be simultaneously recorded using Polar H10 for heart rate variability analysis.
Individualized alpha-band activity (8-12 Hz) will serve as the primary real-time neurofeedback signal, whereas rolling Root Mean Square of Successive Differences (RMSSD) estimates will function as an adaptive physiological controller to dynamically adjust individualized reinforcement thresholds throughout training.
Whenever alpha activity exceeds the adaptive threshold under acceptable signal-quality conditions, synchronized alpha-frequency photic stimulation, binaural beat auditory stimulation, non-directive relaxation guidance, and visual neurofeedback will be automatically delivered.
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Experimental: Neurofeedback Only
Participants will receive adaptive EEG-HRV neurofeedback using the Emotiv Epoc X EEG.
Individualized alpha-band activity will provide real-time visual neurofeedback, while rolling HRV (RMSSD) estimates will dynamically adjust individualized reinforcement thresholds.
No photic stimulation, binaural beat stimulation, or non-directive relaxation guidance will be delivered.
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Participants will receive adaptive EEG-HRV neurofeedback without audiovisual entrainment.
Continuous EEG activity will provide the primary neurofeedback signal based on individualized alpha-band activity (8-12 Hz), while rolling RMSSD estimates will continuously optimize reinforcement thresholds throughout each session.
Participants will receive real-time visual feedback contingent upon their ongoing neural activity.
No rhythmic photic stimulation, binaural beat stimulation, or non-directive relaxation guidance will be administered.
12 intervention sessions will be completed over approximately six weeks.
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Sham Comparator: Sham Control
Participants will undergo a sham intervention using identical equipment, procedures, session duration, and environmental conditions as the active intervention groups.
Although the EEG and HRV sensor will be attached, neither EEG nor HRV signals will influence the feedback provided.
Any visual or audiovisual feedback will be pre-programmed and non-contingent on participants' physiological activity.
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Participants will undergo a sham intervention designed to replicate the appearance and procedures of the active interventions.
The Emotiv Epoc X EEG and Polar H10 HRV sensor will be attached using identical preparation procedures; however, neither EEG activity nor HRV measurements will influence the audiovisual presentation or visual feedback.
Any displayed feedback will be pre-programmed and non-contingent on participants' physiological activity.
Session duration, operator interaction, and environmental conditions will be identical to those of the active intervention groups (12 sessions).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Resting-State Alpha Power
Time Frame: Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)
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Measured via quantitative electroencephalography (qEEG) spectral analysis using the Emotiv Epoc X 14-channel research-grade EEG system from multi-channel frontal (AF3, F7, F3, FC5, FC6, F4, F8, AF4) and temporoparietal (T7, P7, T8, P8) regions of interest.
Absolute alpha power is calculated within the 8-12 Hz frequency band during a 5-minute resting state (standardized 3-minute eyes-closed and 2-minute eyes-open calibration phase).
The power is quantified in microvolts squared (µV²).
An increase in absolute alpha-band power represents enhanced neural self-regulation and a state of relaxed alertness.
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Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Academic Test Anxiety
Time Frame: Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)
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Assessed using the Spielberger Test Anxiety Inventory (TAI).
The total score ranges from a minimum of 20 to a maximum of 80.
A higher total score indicates a greater and more severe level of academic and test anxiety.
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Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)
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Heart Rate Variability (RMSSD)
Time Frame: Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)
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Quantified using the root mean square of successive differences (RMSSD) derived from cardiac activity monitored via the Polar H10 device.
Measured in milliseconds (ms).
Higher RMSSD values indicate enhanced parasympathetic nervous system activity and improved autonomic regulation.
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Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)
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Divergent Thinking - Fluency Score
Time Frame: Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)
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Evaluated using the Alternative Uses Task (AUT).
The fluency score represents the total number of unique alternative uses generated by the participant for the target objects.
The score ranges from a minimum of 0 to no theoretical upper limit.
Higher scores indicate a greater quantity of generated ideas.
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Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)
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Divergent Thinking - Flexibility Score
Time Frame: Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)
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Evaluated using the Alternative Uses Task (AUT).
The flexibility score reflects the number of distinct conceptual categories or domains into which the participant's responses fall.
The score ranges from a minimum of 0 to no theoretical upper limit.
Higher scores indicate a greater conceptual diversity of thought.
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Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)
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Divergent Thinking - Originality Score
Time Frame: Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)
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Evaluated using the Alternative Uses Task (AUT).
The originality score measures the statistical novelty or uniqueness of the participant's ideas compared to the total sample pool or established baseline rubric.
The score ranges from a minimum of 0 to no theoretical upper limit.
Higher scores indicate a higher degree of unique and creative cognition.
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Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)
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Divergent Thinking - Elaboration Score
Time Frame: Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)
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Evaluated using the Alternative Uses Task (AUT).
The elaboration score indicates the level of detail, development, and descriptiveness embedded within each proposed alternative use.
The score ranges from a minimum of 0 to no theoretical upper limit.
Higher scores indicate more thoroughly developed ideas.
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Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Saraswati Eva Yuswikarini, M.Psi., Psychologist, HIMPSI
Publications and helpful links
General Publications
- Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.
- Ros T, Enriquez-Geppert S, Zotev V, Young KD, Wood G, Whitfield-Gabrieli S, Wan F, Vuilleumier P, Vialatte F, Van De Ville D, Todder D, Surmeli T, Sulzer JS, Strehl U, Sterman MB, Steiner NJ, Sorger B, Soekadar SR, Sitaram R, Sherlin LH, Schonenberg M, Scharnowski F, Schabus M, Rubia K, Rosa A, Reiner M, Pineda JA, Paret C, Ossadtchi A, Nicholson AA, Nan W, Minguez J, Micoulaud-Franchi JA, Mehler DMA, Luhrs M, Lubar J, Lotte F, Linden DEJ, Lewis-Peacock JA, Lebedev MA, Lanius RA, Kubler A, Kranczioch C, Koush Y, Konicar L, Kohl SH, Kober SE, Klados MA, Jeunet C, Janssen TWP, Huster RJ, Hoedlmoser K, Hirshberg LM, Heunis S, Hendler T, Hampson M, Guggisberg AG, Guggenberger R, Gruzelier JH, Gobel RW, Gninenko N, Gharabaghi A, Frewen P, Fovet T, Fernandez T, Escolano C, Ehlis AC, Drechsler R, Christopher deCharms R, Debener S, De Ridder D, Davelaar EJ, Congedo M, Cavazza M, Breteler MHM, Brandeis D, Bodurka J, Birbaumer N, Bazanova OM, Barth B, Bamidis PD, Auer T, Arns M, Thibault RT. Consensus on the reporting and experimental design of clinical and cognitive-behavioural neurofeedback studies (CRED-nf checklist). Brain. 2020 Jun 1;143(6):1674-1685. doi: 10.1093/brain/awaa009.
- Attar ET, Balasubramanian V, Subasi E, Kaya M. Stress Analysis Based on Simultaneous Heart Rate Variability and EEG Monitoring. IEEE J Transl Eng Health Med. 2021 Aug 23;9:2700607. doi: 10.1109/JTEHM.2021.3106803. eCollection 2021.
- Gallina J, Marsicano G, Romei V, Bertini C. Electrophysiological and Behavioral Effects of Alpha-Band Sensory Entrainment: Neural Mechanisms and Clinical Applications. Biomedicines. 2023 May 8;11(5):1399. doi: 10.3390/biomedicines11051399.
- Gubenko A, Houssemand C. Alternative Object Use in Adults and Children: Embodied Cognitive Bases of Creativity. Front Psychol. 2022 Sep 2;13:893420. doi: 10.3389/fpsyg.2022.893420. eCollection 2022.
- Caci H, Bayle FJ, Dossios C, Robert P, Boyer P. The Spielberger Trait Anxiety Inventory measures more than anxiety. Eur Psychiatry. 2003 Dec;18(8):394-400. doi: 10.1016/j.eurpsy.2003.05.003.
- Henao D, Navarrete M, Valderrama M, Le Van Quyen M. Entrainment and synchronization of brain oscillations to auditory stimulations. Neurosci Res. 2020 Jul;156:271-278. doi: 10.1016/j.neures.2020.03.004. Epub 2020 Mar 19.
- Gruzelier JH. EEG-neurofeedback for optimising performance. III: a review of methodological and theoretical considerations. Neurosci Biobehav Rev. 2014 Jul;44:159-82. doi: 10.1016/j.neubiorev.2014.03.015. Epub 2014 Mar 29.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AVE-NFB-RCT-DRS-NFO-2026-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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