Non-invasive Brain StimulationCLOSEDLOOPNCT06600217
Closed-loop Non-invasive Brain Stiumlation
An observational study of Non-invasive Brain Stimulation and Methodologic Study, run by University Hospital, Grenoble.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-invasive Brain Stimulation, Methodologic Study
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers from Grenoble and the surrounding area
Who may be able to join
- Signed informed consent
- Having undergone a medical examination prior to participation in research
- Affiliation with or beneficiary of a social security scheme
Who cannot join
- 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.
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mircea Polosan, Prof. contact
About this study
Official title: Développement De La Stimulation Non-invasive En Boucle Fermée
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: Contrast between the 2 TMS-EEG experimental sessions, at day 0 up to day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-invasive Brain StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire de Psychologie et NeuroCognition (LPNC), Université Grenoble Alpes, GIPSA-lab, Grenoble, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600217
- Sponsor's protocol ID
- 38RC24.0193
- Other IDs
- 2024-A01226-41
- Acronym
- CLOSEDLOOP
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28389385
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Développement De La Stimulation Non-invasive En Boucle Fermée
- ClinicalTrials.gov ID
- NCT06600217
- Acronym / sponsor ID
- CLOSEDLOOP / 38RC24.0193
- Conditions
- Non-invasive Brain Stimulation, Methodologic Study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Laboratoire de Psychologie et NeuroCognition (LPNC), Université Grenoble Alpes, GIPSA-lab, Grenoble, France
- Study start
- Oct 2024 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers from Grenoble and the surrounding area
Key inclusion criteria (3 listed)
- Signed informed consent
- Having undergone a medical examination prior to participation in research
- Affiliation with or beneficiary of a social security scheme
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 28389385Harquel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mircea Polosan, Prof. contact
Questions about this trial
What is this clinical trial studying?
An observational study of Non-invasive Brain Stimulation and Methodologic Study, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvain Harquel, Dr. (+33 (0) 4 76 74 81 56, sylvain.harquel@univ-grenoble-alpes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06600217, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.