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NCT Number: NCT06600217

Closed-loop Non-invasive Brain Stiumlation

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).

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. Quality of EEG markers extracted in real-time

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

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

  2. Quality of EEG marker modulation

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

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

Secondary outcomes

  1. 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

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

Study contacts

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

Mircea Polosan, Prof.

CONTACT

[email protected]

Sylvain Harquel, Dr.

CONTACT

[email protected]

+33 (0) 4 76 74 81 56

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • GIPSA-lab, Grenoble, France
  • Laboratoire de Psychologie et NeuroCognition (LPNC), Université Grenoble Alpes

Registry information

Official study title

Développement De La Stimulation Non-invasive En Boucle Fermée

Acronym: CLOSEDLOOP

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

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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