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NCT Number: NCT07251816

Neural Bases of Motivation

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.

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Key information

Conditions

Healthy Volunteers Action Lethargy Motivation Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Equipe ImpAct CRNL, INSERM U1028 CNRS UMR 5292

Bron, 69500, France

Location status: Recruiting

Location contact

Gérard DEROSIERE, Dr

CONTACT

[email protected]

0680872505 ext. +33

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).
  • Participation in other interventional research with an ongoing non-inclusion period.
  • Neurological or psychiatric disorders.
  • Use of tricyclic antidepressants (amitriptyline, clomipramine, imipramine, nortriptyline), neuroleptics (chlorpromazine, haloperidol, risperidone, olanzapine, quetiapine), or recreational drugs within the past 48 hours.
  • Regular use of recreational drugs.
  • Sleep deprivation (< 5 hours regularly over the last 3 months)
  • Left-handedness or ambidexterity.
  • Physical injuries impacting motor tasks.
  • Presence of metal implants in the head (excluding oral fillings).
  • Presence of implanted medical devices (e.g., pacemaker).
  • Presence of metallic injuries in the eyes.
  • Claustrophobia.
  • Piercings incompatible with MRI procedures.
  • Contraindication to MRI
  • Persons who refused to be informed of eventual medical anomalies discovered by the MRI
  • Personal or family history (first-degree relatives) of epilepsy or seizures. Severe and/or frequent headaches (only for participants receiving transcranial magnetic stimulation, e.g preparatory experience 1 and experience 1)
  • Baldness impeding electrode placement (only for participants receiving transcranial electrical stimulation and EEG measurements, e.g experiments 2, 3 and 4)
  • Facial or ear pain and/or recent ear trauma (only for participants receiving transcutaneous vagal nerve stimulation, e.g experiment 5)

Treatment and study plan

Cortico-cortical paired-associative stimulation (ccPAS)

Procedure

Transcranial magnetic stimulation (TMS)

Bifocal transcranial alternating current stimulation (tACS)

Procedure

Transcranial electrical stimulation (tES)

Combining transcranial temporal interference stimulation (tTIS) and oscillatory TMS

Procedure

Transcranial electrical stimulation and transcranial magnetic stimulation

Transcranial Direct Current Stimulation (tDCS)

Procedure

Transcranial electrical stimulation

Transcutaneous vagal nerve stimulation (tVNS)

Procedure

Transcutaneous vagal nerve stimulation (tVNS)

MRI

Procedure

Magnetic Resonance Imaging

MEG

Procedure

Magnetoencephalography

Pupillometry

Procedure

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

Electroencephalography

Primary outcomes

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

    Time frame: Up to 6 months

    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

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

    Time frame: Up to 6 months

    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

Secondary outcomes

  1. fMRI connectivity

    Time frame: Up to 6 months

    fMRI-measured effective connectivity between cerebral structures

  2. EEG-measured synchrony

    Time frame: Up to 6 months

    Measured synchrony as frequency coherence between cortical structures

Study contacts

Contact information is provided by the study sponsor or research team.

Gerard DEROSIERE, Dr

CONTACT

[email protected]

680872505 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: MOTIVACTION

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
Nov 26, 2025
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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