Clinical trial NCT06600217: Closed-loop Non-invasive Brain Stiumlation
Official title: Développement De La Stimulation Non-invasive En Boucle Fermée
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Non-invasive Brain Stimulation
Methodologic Study
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Laboratoire de Psychologie et NeuroCognition (LPNC), UniversitÃ© Grenoble Alpes
name: GIPSA-lab, Grenoble, France
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers from Grenoble and the surrounding area

Brief summary: 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: Inclusion Criteria:

* Signed informed consent
* Having undergone a medical examination prior to participation in research
* Affiliation with or beneficiary of a social security scheme

Exclusion Criteria:

* 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,
* Suspicion of alcohol ingestion prior to the examination,
* Participation in other interventional research protocols in progress with exclusion period or in the preceding week.
* Persons covered by articles L1121-5 to L1121-8 of the CSP (French Public Health Code) (corresponds to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care under articles L.

3212-1 and L. 3213-1 who are not covered by the provisions of article L. 1121-8, persons admitted to a health or social establishment for purposes other than research, minors, persons under legal protection or unable to express their consent).

- Personnel with a hierarchical link to the principal investigator

Primary outcomes:
measure: Quality of EEG markers extracted in real-time
timeFrame: During the two TMS-EEG experimental sessions, at day 0 and up to day 30
measure: Quality of EEG marker modulation
timeFrame: During the two TMS-EEG experimental sessions, at day 0 and up to day 30
Secondary outcomes:
measure: Intra-individual (inter-session) reproducibility of primary endpoint quality markers
timeFrame: Contrast between the 2 TMS-EEG experimental sessions, at day 0 up to day 30
Other outcomes:
Locations:
Study officials:
References:
citation: Harquel S, Diard J, Raffin E, Passera B, Dall'Igna G, Marendaz C, David O, Chauvin A. Automatized set-up procedure for transcranial magnetic stimulation protocols. Neuroimage. 2017 Jun;153:307-318. doi: 10.1016/j.neuroimage.2017.04.001. Epub 2017 Apr 5.