Health TrialsbyHealthPanel

Neural Bases of Motivation

ConditionsHealthy VolunteersMotivationAction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorHospices Civils de Lyon

About this trial

Effort-based decisions are essential in daily life but strongly impaired in apathy across various brain disorders. Now, significant research to unveil the neural causes of apathy is needed. A crucial corollary to this is the need to identify the brain network and neural mechanisms underlying effort-based decisions.

A fronto-striatal network and the noradrenergic system are involved in effort-based decision-making and apathy. Further, motor cortical structures may play a role in effort-based decision-making. However, the role of circuits connecting the fronto-striatal network and the noradrenergic system to the motor structures has been disregarded so far.

Non-invasive brain stimulation methods provide a unique and safe means to test the causal role of connectivity changes between fronto-subcortical and motor structures in effort-based decision-making.

It's now necessary to have an integrative, connectionnist framework to uncover the causal role of connectivity changes between fronto-subcortical and motor structures in effort-based decision-making.

The overarching goal of the present research protocol is to establish an integrative framework testing the causal role of connectivity within recurrent, bidirectional circuits between fronto-subcortical circuits and motor structures in effort-based decision-making. To achieve this overarching goal, investigators will quantifiy the causal role of effective connectivity and oscillatory synchrony in these circuits on effort-related behavior using a non-invasive brain stimulation strategy. Further, a secondary aim is to identify potential non-invasive brain stimulation methods that could increase engagement in effortful behavior, paving the way for translational clinical applications in the context of apathy.

The investigators hypothesize that effort-based decision-making in healthy subjects is governed by bidirectional interactions between fronto-subcortical circuits and motor structures such as the primary motor cortex, mediated by oscillatory synchrony in specific frequency bands (e.g., theta and gamma bands). Accordingly, they hypothesize that transient, non-invasive modulation of connectivity and oscillatory synchrony between these structures in healthy human subjects will directly modulate their decision to engage in effort. Specifically, five experiments will use complementary approaches to test the hypothesis.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy volunteers aged between 18 and 40 years

Participants without confounding factors such as neural alterations related to neurological pathology, whether neurodegenerative (e.g., Alzheimer, Parkinson, Huntington, multiple sclerosis, amyotrophic lateral sclerosis), motor (e.g., dystonia, essential tremors, cerebellar syndrome), traumatic (e.g., traumatic brain injury, medulla lesion) or psychiatric pathologies, whether mood disorders (e.g., depression, bipolarity), anxious troubles (e.g., obsessional compulsive disorder, post-traumatic stress disorder), psychotic (e.g., schizophrenia, delusion), substance-related (e.g., alcool, drug or medicine addiction), food-related (e.g., anorexia, bulimia), neurodevelopmental (e.g., autism, attention-deficit with hyperactivity disorder) or personality (e.g., borderline personality disorder, antisocial personality disorder, obsessive-compulsive disorder).

Participants affiliated with a compulsory social security scheme.

Disqualifiers

Persons deprived of liberty by judicial or administrative decisions.

Pregnant women, women in labor or breastfeeding women

Persons admitted to a health or social institution for purposes other than research.

Adults under legal protection measures (e.g., guardianship or curatorship).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cortico-cortical paired-associative stimulation (ccPAS)

    Procedure/Surgery

    Transcranial magnetic stimulation (TMS)

  • Bifocal transcranial alternating current stimulation (tACS)

    Procedure/Surgery

    Transcranial electrical stimulation (tES)

  • Combining transcranial temporal interference stimulation (tTIS) and oscillatory TMS

    Procedure/Surgery

    Transcranial electrical stimulation and transcranial magnetic stimulation

  • Transcranial direct current stimulation (tDCS)

    Procedure/Surgery

    Transcranial electrical stimulation

  • Transcutaneous vagal nerve stimulation (tVNS)

    Procedure/Surgery

    Transcutaneous vagal nerve stimulation (tVNS)

  • MRI

    Procedure/Surgery

    Magnetic Resonance Imaging

  • MEG

    Procedure/Surgery

    Magnetoencephalography

  • Pupillometry

    Procedure/Surgery

    Measurement and analysis of changes in pupil diameter over time, providing a non-invasive and straightforward method to investigate physiological and psychological processes. Using an eye tracker or pupillometer equipped with infrared cameras, pupil size is measured with high precision and temporal resolution. Pupil responses serve as a proxy for effort invigoration and are linked to multiple neuromodulatory systems, including the noradrenergic system. Recordings will be conducted throughout both experiments, with participants instructed to minimize movements and blinking to ensure data quality.

  • Neuropsychological scales

    Behavioral

    Different neuropsychological scales will be administered to assess various psychological and behavioral dimensions relevant to the study, such as: the Apathy Evaluation Scale (AES): To evaluate levels of apathy ; the Depression Anxiety Stress Scale (DASS): To assess depression, anxiety, and stress ; and the Snaith-Hamilton Pleasure Scale (SHAPS): To evaluate the inability to experience pleasure.

  • EEG

    Procedure/Surgery

    Electroencephalography

Treatment groups

204 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Experiment 1Experimental treatment 4 interventions
Group B: Experiment 2Experimental treatment 5 interventions
Group C: Experiment 3Experimental treatment 5 interventions
Group D: Experiment 4Experimental treatment 4 interventions
Group E: Experiment 5Experimental treatment 4 interventions
Group F: Preparatory experiment 1Experimental treatment 4 interventions
Group G: Preparatory experiment 2Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Acceptance rates (from 0 to 100 % of acceptance) for behavioral outcomes. Connectivity and oscillatory changes for neural activity

Acceptance rate is the participant's willingness to engage in effortful tasks for rewards and reaction times measure the rapidity to approach or avoid the effort. Connectivity and oscillatory changes will be analyses with imaging data

Time frame
Up to 6 months
2

Reaction times (in ms) for behavioral outcomes. Connectivity and oscillatory changes for neural activity

Acceptance rate is the participant's willingness to engage in effortful tasks for rewards and reaction times measure the rapidity to approach or avoid the effort. Connectivity and oscillatory changes will be analyses with imaging data

Time frame
Up to 6 months

Secondary outcomes

1

fMRI connectivity

fMRI-measured effective connectivity between cerebral structures

Time frame
Up to 6 months
2

EEG-measured synchrony

Measured synchrony as frequency coherence between cortical structures

Time frame
Up to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospices Civils de Lyon

Lead sponsor

Source ClinicalTrials.gov
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