HealthyNCT04876170
Reward Circuit Modulation Via fMRI-informed-EEG-based Musical Neurofeedback
A study testing Brain-computer-interface: EEG-based musical Neurofeedback task in people with Healthy, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The goal of this study is to test whether voluntary up-regulation of mesolimbic reward system activation is possible, and to examine the neurobehavioral effects of specific neuromodulation of this circuit on reward processing. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Brain-computer-interface: EEG-based musical Neurofeedback task
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Jul 2020to 10 Sep 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy without known background diseases Without known cognitive decline Have normal hearing Dominance of the right hand No history of psychiatric or neurological illnesses requiring hospitalization. The accepted criteria for inclusion for an MRI examination for medical purposes will apply, in accordance with the procedures established at the MRI Institute at the Sourasky Medical Center in Tel Aviv.
Who cannot join
- Has a diagnosis of psychiatric or neurological diseases Uses psychiatric or neurological medications Hearing loss The accepted criteria for exclusion for an MRI examination for medical purposes will apply, according to the procedures established at the MRI Institute at the Sourasky Medical Center in Tel Aviv
Trial locations and contacts
1 site in 1 country.
Neomi Singer, PhD contact
Israel1 site, 1 recruiting
- Recruiting
Sagol Brain Institute, Tel Aviv Sourasky Medical Center
Tel Aviv
Talma Hendler, MD, PhD, 972-36973953, talma@tlvmc.gov.il
About this study
Official title: Reward Circuit Modulation Via EEG-based Neurofeedback
The goal of this study is to test whether voluntary up-regulation of mesolimbic reward system activation is possible, and to examine the neurobehavioral effects of specific neuromodulation of this circuit on reward processing. This goal will be achieved by testing the effects of a novel non-invasive experimental framework for neuromodulation that relies on neurofeedback (NF), which is guided by neuronal activation in the ventral striatum (VS) and interfaced with personalized pleasurable music as feedback. We Hypothesize that it is possible to learn to volitionally regulate the VS using this musical NF approach. We further predict that successful NF training for up-regulating the VS-EFP signal will result in marked changes in neural and behavioral outcomes associated with upregulation of dopaminergic signaling.
Read the detailed description
Neurofeedback is a training approach in which people learn to regulate their brain activity by using a feedback signal that reflects real-time brain signals. An effective utilization of this approach requires that the represented brain activity be measured with high specificity, yet in an accessible manner, enabling repeated sessions. Evidence suggests that individuals are capable to volitionally regulate their own regional neural activation, including in deep brain regions such as the VS via real-time functional Magnetic Resonance Imaging (rt-fMRI). Yet, the utility of rt-fMRI-NF for repeated training is limited due to immobility, high-cost and extensive physical requirements. Electroencephalography (EEG), on the other hand, is low-cost and accessible. However, the behavioral and clinical benefits of EEG-NF, especially within the context of depression and other affective disorders are still debated. Previous work from Hendler's lab has established a novel framework for an accessible probing of specific brain networks termed electrical fingerprinting [1]. The fingerprinting relies on the statistical modeling of an fMRI-inspired EEG pattern based on a simultaneous recording of EEG/fMRI in combination with learning algorithms. This approach has been successfully applied and validated for the amygdala, revealing successful modulation of the EFP-amygdala signal during NF training, as well as lingering neuronal and behavioral effects among trainees, relative to sham-NF training. In the current study, the NF training procedure utilizes a newly developed fMRI-inspired EEG model of mesolimbic activity, centered on the VS; VS-electrical fingerprint (VS-EFP). Furthermore, to improve accessibility to the mesolimbic system, the feedback interface is based on pleasurable music, which has been repeatedly shown to engage the reward circuit and lead to dopaminergic release within the striatum [e.g, 2; cf. 3]. The basic principle behind the musical interface is that during training, participants are presented with their self-selected music, which becomes more or less acoustically distorted so as to reliably alter its level of pleasantness in real-time. A feasibility study with twenty participants (N=10 test group, N=10 control group), which was conducted at McGill, demonstrated the feasibility of this approach. In the current study, we wish to replicate and extend these findings in a larger sample (N=~40; N=20 test group and N=20 sham-control group) and to test the hypotheses arisen in this study with regards to its possible neurobehavioral outcomes.
- Conditions
- Healthy
- Being tested
- Brain-computer-interface: EEG-based musical Neurofeedback task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain-computer-interface: EEG-based musical Neurofeedback taskOther
Neurofeedback training with EEG, in which participants are presented with self-selected music and requested to make the presented music sound better by applying mental strategies. Six repeated training sessions, each composed of five training cycles. Each cycle is composed of 120 sec of 'local baseline' block and 90 sec of 'regulation' block while listening to self-selected music. Participants are instructed to passively listen to their self-selected music during the 'local baseline' block, and to 'make the music sound better' during the 'regulation' block. Participants are instructed to recruit chosen mental strategies, which they find to be most efficient towards this regulatory task. During 'regulation', the quality of the sound varies in real-time (every 3 sec) in proportion to the difference between the current value of VS-EFP and its average value during 'local baseline'.
| Study group | Role | What they receive |
|---|---|---|
| VS-EFP Neurofeedback | Active comparator | Neurofeedback is based on the learned change in a particular neural signal or a combination of neural signals when feedback and reward of these signals are repeatedly presented to the organism. Thus, individuals learn to modulate their neural activity through a closed NF loop; in this condition, participants will receive musical feedback driven by their own VS-EFP Receives: Other: Brain-computer-interface: EEG-based musical Neurofeedback task |
| Yoked sham Neurofeedback | Sham comparator | Neurofeedback is based on the learned change in a particular neural signal or a combination of neural signals when feedback and reward of these signals are repeatedly presented to the organism. Thus, individuals learn to modulate their neural activity through a closed NF loop; in this condition, the musical feedback will be provided based on another participant's VS-EFP signal. Hence, each participant from the sham group is paired with a participant from the test group, thus receiving feedback based on the paired test participant. This way, both groups are exposed to the exact proportion of sound manipulation that indicates their success level. To account for a possible contribution of the temporal order of feedback presentation, in half of the control participants, the feedback pattern will be "replayed" forward (maintaining the original temporal pattern of VS-EFP that the paired participant has received), and in half - backward (flipping the original temporal pattern right-to-left). Receives: Other: Brain-computer-interface: EEG-based musical Neurofeedback task |
What is being measured
The primary outcome is the main question the study is designed to answer.
VS-EFP regulation success
Measured by change in VS-EFP power; based on the difference between EFP during 'regulate' and 'local baseline' conditions during the neurofeedback cycles. The investigators predict a greater modulation of VS-EFP power among the neurofeedback group relative to sham controls (test > sham).
Measured: 0 to 4 weeks
Transfer of VS-EFP regulation: VS-EFP volitional regulation success under a different context
Measured by change in VS-EFP power; based on the difference between regulate and local baseline conditions during the transfer condition; volitional regulation when no music or feedback is provided. The transfer condition is introduced at the beginning of each training session. The investigators predict a positive change in VS-EFP regulation following successful training among the neurofeedback group, relative to sham controls.
Measured: 1 to 5 weeks
Mesolimbic self-regulation under a different context
Measured via fMRI; a transfer task (volitional regulation when no feedback is applied) during an fMRI scan, which will take place before and after the entire training period. Region of interest (ROI) analysis of the ventral striatum (VS) will be defined based on the target region used for developing the VS-EFP. Additional regions of the mesolimbic network will be defined based on a meta-analysis of reward.
The outcome will be measured for each group, as the change (post > pre) in the contrast between 'regulate' and 'local-baseline' condition.
The investigators predict a positive change in VS upregulation following successful training among the neurofeedback group, relative to sham controls.
Exploratory analysis: the investigators intend to further explore whether NF training resulted in a positive change in the upregulation of additional mesolimbic nodes.
Measured: 1 to 5 weeks
Secondary outcomes (3)
Reward-learning behavior
Assessed via the performance in probabilistic selection task (PST), which will be administered before and after the entire training period. This is a task of probabilistic reward learning, in which participants' ability to learn to choose a frequently rewarded symbol (e.g., symbol A which is rewarded 80% of the times) or to avoid a rarely rewarded symbol (B, 20% of the times) is examined [4].
The outcome will be measured for each group, as the change (post > pre) in the accuracy of learning from reward (select A) or from punishments (avoid B).
The investigators predict a positive change in learning from rewards following successful training among the neurofeedback group, relative to sham controls.
Measured: 1 to 5 weeks
Incentive motivation behavior
Measured via the performance in the Effort Expenditure for Rewards Task (Eefrt task), which will be administered before and after the entire training period. This is an effort-based decision-making task, in which participants choose to perform a 'hard' vs. 'easy' task for gaining varying amounts of monetary rewards under low/medium/high probability of reward receipt [5].
The outcome will be measured for each group, as the change (post >pre) in the proportion of choosing to expend more effort for a high/low monetary gain under high/medium/low probability.
The investigators predict a positive change in the proportion of choosing the hard task for high monetary gain under lower probabilities of gaining rewards following successful training among the neurofeedback group, relative to sham controls.
Measured: 1 to 5 weeks
Hedonic trait: link between hedonic traits and neurofeedback success
Measured via the Snaith Hemilton Pleasure Scale (SHAPS), a 14 item questionnaire that assesses hedonic capacity; an index of c-anhedonia will be derived as the sum of the responses [6].
The investigators predict that there will be a negative correlation between anhedonia scores following training and the performance in the NF-VS-EFP among the neurofeedback group.
Measured: 1 to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start10 Jul 2020
- Primary completion10 Sep 2021 (estimated)
- Study completion10 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel Aviv University, McGill University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876170
- Sponsor's protocol ID
- 0401-17-TLV
- Other IDs
- 00040030000
- Status last verified
- May 2021
- First submitted
- 2 May 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Meir-Hasson Y, Kinreich S, Podlipsky I, Hendler T, Intrator N. An EEG Finger-Print of fMRI deep regional activation. Neuroimage. 2014 Nov 15;102 Pt 1:128-41. doi: 10.1016/j.neuroimage.2013.11.004. Epub 2013 Nov 15.
PubMed 24246494Salimpoor VN, Benovoy M, Larcher K, Dagher A, Zatorre RJ. Anatomically distinct dopamine release during anticipation and experience of peak emotion to music. Nat Neurosci. 2011 Feb;14(2):257-62. doi: 10.1038/nn.2726. Epub 2011 Jan 9.
PubMed 21217764Mas-Herrero E, Maini L, Sescousse G, Zatorre RJ. Common and distinct neural correlates of music and food-induced pleasure: A coordinate-based meta-analysis of neuroimaging studies. Neurosci Biobehav Rev. 2021 Apr;123:61-71. doi: 10.1016/j.neubiorev.2020.12.008. Epub 2021 Jan 10.
PubMed 33440196Frank MJ, Seeberger LC, O'reilly RC. By carrot or by stick: cognitive reinforcement learning in parkinsonism. Science. 2004 Dec 10;306(5703):1940-3. doi: 10.1126/science.1102941. Epub 2004 Nov 4.
PubMed 15528409Treadway MT, Buckholtz JW, Schwartzman AN, Lambert WE, Zald DH. Worth the 'EEfRT'? The effort expenditure for rewards task as an objective measure of motivation and anhedonia. PLoS One. 2009 Aug 12;4(8):e6598. doi: 10.1371/journal.pone.0006598.
PubMed 19672310Snaith RP, Hamilton M, Morley S, Humayan A, Hargreaves D, Trigwell P. A scale for the assessment of hedonic tone the Snaith-Hamilton Pleasure Scale. Br J Psychiatry. 1995 Jul;167(1):99-103. doi: 10.1192/bjp.167.1.99.
PubMed 7551619Mas-Herrero E, Marco-Pallares J, Lorenzo-Seva U, Zatorre RJ, & Rodriguez-Fornells A 2012. Individual differences in music reward experiences. Music Perception, 31(2), 118-138.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reward Circuit Modulation Via EEG-based Neurofeedback
- ClinicalTrials.gov ID
- NCT04876170
- Acronym / sponsor ID
- 0401-17-TLV
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Tel Aviv University, McGill University
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 10 Sep 2021 (estimated)
- Study completion
- 10 Sep 2021 (estimated)
- First posted
- 6 May 2021 (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 test whether voluntary up-regulation of mesolimbic reward system activation is possible, and to examine the neurobehavioral effects of specific neuromodulation of this circuit on reward processing. This goal will be achieved by testing the effects of a novel non-invasive experimental framework for neuromodulation that relies on neurofeedback (NF), which is guided by neuronal activation in the ventral striatum (VS) and interfaced with personalized pleasurable music as feedback. We Hypothesize that it is possible to learn to volitionally regulate the VS using this musical NF approach. We further predict that successful NF training for up-regulating the VS-EFP signal will result in marked changes in neural and behavioral outcomes associated with upregulation of dopaminergic signaling.
Detailed description
Neurofeedback is a training approach in which people learn to regulate their brain activity by using a feedback signal that reflects real-time brain signals. An effective utilization of this approach requires that the represented brain activity be measured with high specificity, yet in an accessible manner, enabling repeated sessions. Evidence suggests that individuals are capable to volitionally regulate their own regional neural activation, including in deep brain regions such as the VS via real-time functional Magnetic Resonance Imaging (rt-fMRI). Yet, the utility of rt-fMRI-NF for repeated training is limited due to immobility, high-cost and extensive physical requirements. Electroencephalography (EEG), on the other hand, is low-cost and accessible. However, the behavioral and clinical benefits of EEG-NF, especially within the context of depression and other affective disorders are still debated. Previous work from Hendler's lab has established a novel framework for an accessible probing of specific brain networks termed electrical fingerprinting [1]. The fingerprinting relies on the statistical modeling of an fMRI-inspired EEG pattern based on a simultaneous recording of EEG/fMRI in combination with learning algorithms. This approach has been successfully applied and validated for the amygdala, revealing successful modulation of the EFP-amygdala signal during NF training, as well as lingering neuronal and behavioral effects among trainees, relative to sham-NF training. In the current study, the NF training procedure utilizes a newly developed fMRI-inspired EEG model of mesolimbic activity, centered on the VS; VS-electrical fingerprint (VS-EFP). Furthermore, to improve accessibility to the mesolimbic system, the feedback interface is based on pleasurable music, which has been repeatedly shown to engage the reward circuit and lead to dopaminergic release within the striatum [e.g, 2; cf. 3]. The basic principle behind the musical interface is that during training, participants are presented with their self-selected music, which becomes more or less acoustically distorted so as to reliably alter its level of pleasantness in real-time. A feasibility study with twenty participants (N=10 test group, N=10 control group), which was conducted at McGill, demonstrated the feasibility of this approach. In the current study, we wish to replicate and extend these findings in a larger sample (N=~40; N=20 test group and N=20 sham-control group) and to test the hypotheses arisen in this study with regards to its possible neurobehavioral outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VS-EFP Neurofeedback | Active comparator | Other: Brain-computer-interface: EEG-based musical Neurofeedback taskNeurofeedback is based on the learned change in a particular neural signal or a combination of neural signals when feedback and reward of these signals are repeatedly presented to the organism. Thus, individuals learn to modulate their neural activity through a closed NF loop; in this condition, participants will receive musical feedback driven by their own VS-EFP |
| Yoked sham Neurofeedback | Sham comparator | Other: Brain-computer-interface: EEG-based musical Neurofeedback taskNeurofeedback is based on the learned change in a particular neural signal or a combination of neural signals when feedback and reward of these signals are repeatedly presented to the organism. Thus, individuals learn to modulate their neural activity through a closed NF loop; in this condition, the musical feedback will be provided based on another participant's VS-EFP signal. Hence, each participant from the sham group is paired with a participant from the test group, thus receiving feedback based on the paired test participant. This way, both groups are exposed to the exact proportion of sound manipulation that indicates their success level. To account for a possible contribution of the temporal order of feedback presentation, in half of the control participants, the feedback pattern will be "replayed" forward (maintaining the original temporal pattern of VS-EFP that the paired participant has received), and in half - backward (flipping the original temporal pattern right-to-left). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy without known background diseases Without known cognitive decline Have normal hearing Dominance of the right hand No history of psychiatric or neurological illnesses requiring hospitalization. The accepted criteria for inclusion for an MRI examination for medical purposes will apply, in accordance with the procedures established at the MRI Institute at the Sourasky Medical Center in Tel Aviv.
Key exclusion criteria (1 listed)
- Has a diagnosis of psychiatric or neurological diseases Uses psychiatric or neurological medications Hearing loss The accepted criteria for exclusion for an MRI examination for medical purposes will apply, according to the procedures established at the MRI Institute at the Sourasky Medical Center in Tel Aviv
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 |
|---|---|---|
| Brain-computer-interface: EEG-based musical Neurofeedback taskNeurofeedback training with EEG, in which participants are presented with self-selected music and requested to make the presented music sound better by applying mental strategies. Six repeated training sessions, each composed of five training cycles. Each cycle is composed of 120 sec of 'local baseline' block and 90 sec of 'regulation' block while listening to self-selected music. Participants are instructed to passively listen to their self-selected music during the 'local baseline' block, and to 'make the music sound better' during the 'regulation' block. Participants are instructed to recruit chosen mental strategies, which they find to be most efficient towards this regulatory task. During 'regulation', the quality of the sound varies in real-time (every 3 sec) in proportion to the difference between the current value of VS-EFP and its average value during 'local baseline'. | Other | VS-EFP Neurofeedback, Yoked sham Neurofeedback |
Primary outcome
VS-EFP regulation success
Time frame: 0 to 4 weeks
Measured by change in VS-EFP power; based on the difference between EFP during 'regulate' and 'local baseline' conditions during the neurofeedback cycles. The investigators predict a greater modulation of VS-EFP power among the neurofeedback group relative to sham controls (test > sham).
Transfer of VS-EFP regulation: VS-EFP volitional regulation success under a different context
Time frame: 1 to 5 weeks
Measured by change in VS-EFP power; based on the difference between regulate and local baseline conditions during the transfer condition; volitional regulation when no music or feedback is provided. The transfer condition is introduced at the beginning of each training session. The investigators predict a positive change in VS-EFP regulation following successful training among the neurofeedback group, relative to sham controls.
Mesolimbic self-regulation under a different context
Time frame: 1 to 5 weeks
Measured via fMRI; a transfer task (volitional regulation when no feedback is applied) during an fMRI scan, which will take place before and after the entire training period. Region of interest (ROI) analysis of the ventral striatum (VS) will be defined based on the target region used for developing the VS-EFP. Additional regions of the mesolimbic network will be defined based on a meta-analysis of reward. The outcome will be measured for each group, as the change (post > pre) in the contrast between 'regulate' and 'local-baseline' condition. The investigators predict a positive change in VS upregulation following successful training among the neurofeedback group, relative to sham controls. Exploratory analysis: the investigators intend to further explore whether NF training resulted in a positive change in the upregulation of additional mesolimbic nodes.
3 secondary outcomes
Reward-learning behavior
Time frame: 1 to 5 weeks
Incentive motivation behavior
Time frame: 1 to 5 weeks
Hedonic trait: link between hedonic traits and neurofeedback success
Time frame: 1 to 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Background: PubMed 24246494Meir-Hasson Y, Kinreich S, Podlipsky I, Hendler T, Intrator N. An EEG Finger-Print of fMRI deep regional activation. Neuroimage. 2014 Nov 15;102 Pt 1:128-41. doi: 10.1016/j.neuroimage.2013.11.004. Epub 2013 Nov 15.
- Background: PubMed 21217764Salimpoor VN, Benovoy M, Larcher K, Dagher A, Zatorre RJ. Anatomically distinct dopamine release during anticipation and experience of peak emotion to music. Nat Neurosci. 2011 Feb;14(2):257-62. doi: 10.1038/nn.2726. Epub 2011 Jan 9.
- Background: PubMed 33440196Mas-Herrero E, Maini L, Sescousse G, Zatorre RJ. Common and distinct neural correlates of music and food-induced pleasure: A coordinate-based meta-analysis of neuroimaging studies. Neurosci Biobehav Rev. 2021 Apr;123:61-71. doi: 10.1016/j.neubiorev.2020.12.008. Epub 2021 Jan 10.
- Background: PubMed 15528409Frank MJ, Seeberger LC, O'reilly RC. By carrot or by stick: cognitive reinforcement learning in parkinsonism. Science. 2004 Dec 10;306(5703):1940-3. doi: 10.1126/science.1102941. Epub 2004 Nov 4.
- Background: PubMed 19672310Treadway MT, Buckholtz JW, Schwartzman AN, Lambert WE, Zald DH. Worth the 'EEfRT'? The effort expenditure for rewards task as an objective measure of motivation and anhedonia. PLoS One. 2009 Aug 12;4(8):e6598. doi: 10.1371/journal.pone.0006598.
- Background: PubMed 7551619Snaith RP, Hamilton M, Morley S, Humayan A, Hargreaves D, Trigwell P. A scale for the assessment of hedonic tone the Snaith-Hamilton Pleasure Scale. Br J Psychiatry. 1995 Jul;167(1):99-103. doi: 10.1192/bjp.167.1.99.
- BackgroundMas-Herrero E, Marco-Pallares J, Lorenzo-Seva U, Zatorre RJ, & Rodriguez-Fornells A 2012. Individual differences in music reward experiences. Music Perception, 31(2), 118-138.
- Individual participant dataSharing planned: Undecided
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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.
Neomi Singer, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain-computer-interface: EEG-based musical Neurofeedback task in people with Healthy, 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 6 May 2021. 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?
Contact Talma Hendler, MD, PhD (972-36973953, talma@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VS-EFP regulation success (time frame: 0 to 4 weeks). The study lists 3 primary outcomes in all. 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 NCT04876170, which also lists 7 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 6 May 2021.