Reward Circuit Modulation Via fMRI-informed-EEG-based Musical Neurofeedback

NCT04876170 | Unknown

• 2 other identifiers: 0401-17-TLV00040030000
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

  1 to 5 weeks

Secondary Outcomes (3)

• Reward-learning behavior

  1 to 5 weeks

• Incentive motivation behavior

  1 to 5 weeks

• Hedonic trait: link between hedonic traits and neurofeedback success

  1 to 5 weeks

Other Outcomes (1)

• Reward processing (neural): mesolimbic reactivity to rewards (i.e., monetary, musical pleasure)

  1 to 5 weeks

Study Arms (2)

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

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).

Other: Brain-computer-interface: EEG-based musical Neurofeedback task

Interventions

Brain-computer-interface: EEG-based musical Neurofeedback task OTHER

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'.

VS-EFP Neurofeedback; Yoked sham Neurofeedback

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Tel Aviv University: collaborator
• McGill University: collaborator

Study Sites (1)

Sagol Brain Institute, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

Related Publications (7)

• 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.

  PMID: 24246494 BACKGROUND

• Salimpoor 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.

  PMID: 21217764 BACKGROUND

• Mas-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.

  PMID: 33440196 BACKGROUND

• Frank 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.

  PMID: 15528409 BACKGROUND

• Treadway 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.

  PMID: 19672310 BACKGROUND

• Snaith 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.

  PMID: 7551619 BACKGROUND

• Mas-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.

  BACKGROUND

Central Study Contacts

Talma Hendler, MD, PhD

CONTACT

972-36973953; talma@tlvmc.gov.il

Neomi Singer, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2021
• First Posted: May 6, 2021
• Study Start: July 10, 2020
• Primary Completion: September 10, 2021
• Study Completion: September 10, 2021
• Last Updated: May 6, 2021

Record last verified: 2021-05

Locations

IL (1)