Closed-loop Non-invasive Brain Stiumlation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-40
SponsorUniversity Hospital, Grenoble

About this trial

Transcranial magnetic stimulation (TMS) is a widely used tool for exploring brain function in humans (Siebner et al. et al., 2022), which has led to new therapeutics for various psychiatric and neurological disorders (Lefaucheur et al., 2020). However, the open-loop use of this technique has raised questions about its operating principle, due to the high degree of heterogeneity of results and the small to medium observed effect sizes (Zrenner and Ziemann, 2023). To increase the response rate, it has been suggested to individualize stimulation, by adapting the TMS parameters (i.e. delivered dose, target dose, targeting, timing, etc.) to instantaneous estimates of brain brain state. Such an approach, known as closed-loop closed-loop stimulation, is currently one of the main challenges challenges in this field (closed-loop brain state-dependent stimulation). To this end, we are focusing on the combination of robotic TMS and electroencephalography (EEG) (Hernandez-Pavon et al. al., 2023). The closed-loop stimulations using this combination developed to date have two limitations: (i) they are not adaptive and focus focus mainly on calculating the phase of brain oscillations to trigger stimulation and (ii) are limited to central cortical (sensorimotor) areas, where the EEG signal-to-noise ratio is optimal.

This project aims to develop closed-loop TMS-EEG protocols that overcome these two limitations: (i) by incorporating adaptive decision modeling (AutoHS model, Harquel et al. 2017) to optimize several parameters in parallel (coil location, orientation, intensity) while using a wider range of EEG markers (evoked potentials, oscillatory activity strength, connectivity, etc.), and (ii) by integrating real-time EEG pre-processing to access any cortical target (including frontal, temporal and occipital lobes).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Signed informed consent

Having undergone a medical examination prior to participation in research

Affiliation with or beneficiary of a social security scheme

Disqualifiers

Contraindications (CI) to MRI, EEG, TMS practice

Existence of a severe general medical condition: cardiac, respiratory, hematological, renal, hepatic, cancerous,

Regular use of anxiolytics, sedatives, antidepressants, neuroleptics,

Characterized psychiatric pathology,

Trial population

Healthy volunteers from Grenoble and the surrounding area

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 1 trial group
Group A: Healthy subjects

Trial outcomes

Primary outcomes

1

Quality of EEG markers extracted in real-time

Quality of EEG markers extracted in real-time (evoked potentials, power and phase of brain oscillations and functional connectivity)

Time frame
During the two TMS-EEG experimental sessions, at day 0 and up to day 30
2

Quality of EEG marker modulation

Quality of EEG marker modulation induced by TMS parameters selected by the AutoHS decision model

Time frame
During the two TMS-EEG experimental sessions, at day 0 and up to day 30

Secondary outcomes

1

Intra-individual (inter-session) reproducibility of primary endpoint quality markers

Intra-individual (inter-session) reproducibility of primary endpoint quality markers

Time frame
Contrast between the 2 TMS-EEG experimental sessions, at day 0 up to day 30

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

University Hospital, Grenoble

Lead sponsor

Laboratoire de Psychologie et NeuroCognition (LPNC), Université Grenoble Alpes

Collaborator

GIPSA-lab, Grenoble, France

Collaborator

This trial is not recruiting at the moment. You can still explore other options: