Menu
Not yet recruiting NCT06600217

Closed-loop Non-invasive Brain Stiumlation

— Observational Non-invasive Brain Stimulation Methodologic Study

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Non-invasive Brain Stimulation, Methodologic Study. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Développement De La Stimulation Non-invasive En Boucle Fermée

Overview

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).

Primary outcome measures

  • 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 marker modulation [Time frame: During the two TMS-EEG experimental sessions, at day 0 and up to day 30]
Secondary outcome measures (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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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

Identifiers

NCT: NCT06600217 · 38RC24.0193 · 2024-A01226-41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗