Closed-loop Non-invasive Brain Stiumlation

NCT06600217 | Not Yet Recruiting

• 2 other identifiers: 38RC24.01932024-A01226-41
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Non-invasive Brain Stimulation; Methodologic Study

Outcome Measures

Primary Outcomes (2)

• 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)

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

• Quality of EEG marker modulation

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

  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

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

Study Arms (1)

Healthy subjects

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers from Grenoble and the surrounding area

You may qualify if:

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

You may not qualify if:

• 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,
• 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.
• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Laboratoire de Psychologie et NeuroCognition (LPNC), Université Grenoble Alpes: collaborator
• GIPSA-lab, Grenoble, France: collaborator

Related Publications (1)

• 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.

  PMID: 28389385 BACKGROUND

Central Study Contacts

Sylvain Harquel, Dr.

CONTACT

+33 (0) 4 76 74 81 56; sylvain.harquel@univ-grenoble-alpes.fr

Mircea Polosan, Prof.

CONTACT

mpolosan@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share