NormoxiaNEUROXIENCT07516028
Brain Connectivity and Corticospinal Excitability in Response to Moderate Hypoxia
A study testing Moderate hypoxia, Normoxia and Transcranial Magnetic Stimulation in people with Normoxia and Intermittent Moderate Hypoxia, run by Universite du Littoral Cote d'Opale at 1 site in France.
Trial summary
Hypoxia, defined as a reduction in the availability of oxygen, induces significant physiological adaptations. While the deleterious effects of severe and chronic hypoxia are well documented, several studies indicate that moderate hypoxia - particularly when administered intermittently - may produce beneficial effects… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Normoxia, Intermittent Moderate Hypoxia, Continuous Moderate Hypoxia
- What is being tested?
- Moderate hypoxia, Normoxia and Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2026to 20 Dec 2026
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged 18 to 65 years
- Healthy right- or left-handed individuals with no self-reported neurological disorders or history of neurological conditions (e.g., epilepsy, stroke, brain or spinal surgery, or neurological diseases affecting motor or sensory function such as multiple sclerosis, or neurodegenerative diseases such as Parkinson's or Alzheimer's)
- Individuals who have provided informed consent and have sufficient proficiency in French
- Participants affiliated with, or beneficiaries of, a social security scheme
Who cannot join
- Body mass index (BMI) greater than 30 kg/m²
- Diagnosed and untreated obstructive sleep apnoea syndrome
- Inability to provide informed consent
- History of cardiac (e.g., ischaemic heart disease, heart failure) and/or respiratory disorders (e.g., COPD, chronic respiratory insufficiency, persistent or uncontrolled asthma)
- Current smokers
- Contraindications to TMS (e.g., uncontrolled epilepsy, intracranial metallic foreign body, hearing aid or cochlear implant, implanted stimulator or pump, scalp lesions, elevated intracranial pressure, cerebrospinal fluid shunt)
Show all 10Show fewer
- Use of psychotropic medication
- Individuals under legal guardianship or curatorship
- Pregnant or breastfeeding women
- Participants who have flown by air or travelled to terrestrial altitudes above 1500 metres within the seven days prior to inclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Eurasport
Loos, Hauts-de-France, 59120
Serge Berthoin, PhD, +33 3 74 00 82 02, serge.berthoin@univ-lille.fr
About this study
Hypoxia, defined as a reduction in the availability of oxygen, induces significant physiological adaptations. While the deleterious effects of severe and chronic hypoxia are well documented, several studies indicate that moderate hypoxia - particularly when administered intermittently - may produce beneficial effects on cardiometabolic health (e.g., improved regulation of blood pressure and better glycaemic control). However, its impact on the dynamics of brain circuits in humans remains relatively underexplored. The present project aims to characterise the effects of continuous and intermittent moderate hypoxia on resting-state brain dynamics in healthy adults. To this end, simultaneous electroencephalography (EEG) and functional near-infrared spectroscopy (fNIRS) recordings will be conducted in order to extract functional and haemodynamic markers of brain activity. This project will contribute to a better understanding of the neurophysiological mechanisms associated with hypoxic conditioning and to the assessment of its potential application in innovative therapeutic approaches.
Read the detailed description
Hypoxia refers to a condition in which the availability of oxygen (O₂) is reduced relative to normal conditions. While severe hypoxia is well known for its deleterious effects, moderate hypoxia - particularly when administered intermittently - may produce potentially beneficial effects on cardiometabolic health, such as improved regulation of blood pressure and enhanced energy metabolism.
Animal models indicate that hypoxia can promote the expression of neurotrophic factors, stimulate neuroplasticity, and enhance cerebrovascular function. In humans, several studies suggest that intermittent hypoxia induces more pronounced cardiometabolic adaptations than continuous hypoxia and may improve certain cognitive functions in older adults. Recent findings also indicate that moderate hypoxia alters spontaneous brain activity at rest, particularly in the alpha frequency band, suggesting a possible influence on functional brain networks.
However, the effects of moderate hypoxia on resting-state brain dynamics remain poorly documented in humans. A detailed characterisation of both the electrical and haemodynamic responses of the brain is therefore required in order to better understand the potential adaptive processes involved and to evaluate the relevance of intermittent hypoxia as a non-pharmacological intervention for optimising brain health.
The primary objective of this project is to evaluate the effects of continuous and intermittent moderate hypoxia on resting-state brain dynamics in healthy individuals. To this end, simultaneous EEG and fNIRS recordings will be collected in order to extract functional markers of resting brain activity. A secondary objective is to investigate the impact of moderate hypoxia on brain connectivity and corticospinal excitability.
This is a single-centre exploratory descriptive study. Each participant will be assessed during three experimental sessions (i.e. intermittent hypoxia, continuous hypoxia, and normoxia) separated by at least one week and presented in a pseudo-randomised order. During the hypoxic periods, a peripheral oxygen saturation (SpO₂) between 85% and 90% will be targeted.
- Session A: exposure to continuous moderate hypoxia (30 minutes)
- Session B: exposure to intermittent moderate hypoxia (six cycles of 5 minutes of hypoxia followed by 5 minutes of normoxia)
- Session C: exposure to normoxia for 30 minutes
Participants will be fitted with a cap enabling the simultaneous recording of EEG activity and haemodynamic signals (via measurements of oxyhaemoglobin [HbO₂] and deoxyhaemoglobin [HbR] concentrations) using fNIRS. The activity of the first dorsal interosseous muscle of the dominant hand will be recorded using surface electromyography. During the recordings (i.e., hypoxia or normoxia exposure), participants will remain at rest, without any motor activity or specific cognitive stimulation.
Corticospinal excitability will be assessed using TMS before and after each hypoxic exposure period. For this purpose, we will measure the amplitude of motor-evoked potentials in the first dorsal interosseous muscle of the dominant hand following stimulation of the contralateral motor cortex using TMS at 120% of the resting motor threshold. This measure will be complemented by the assessment of the efficiency of three intracortical mechanisms that contribute to changes in the excitability of the primary motor cortex: short- and long-interval intracortical inhibition (SICI and LICI, respectively), as well as intracortical facilitation (ICF). These measures will be obtained using paired-pulse TMS protocols.
- Being tested
- Moderate hypoxia, Normoxia, Transcranial Magnetic Stimulation
- Keywords
- hypoxia, eeg, fnirs, motor-evoked potentials, tms
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate hypoxiaDevice
Altitude conditions (normobaric hypoxia) will be reproduced using the OnePlus VA device (GO2Altitude, Biomedtech, Melbourne, Australia). This device modulates the fraction of inspired oxygen (FiO₂) through a patented semi-permeable membrane system developed by the company. It thereby produces a gas mixture that is inhaled by the participant through a mask. This device included an oxygen-reduction algorithm, that adjusts the FiO₂ in real time according to a target peripheral oxygen saturation (SpO₂ = 85-90%).
NormoxiaDevice
Ambient air will be delivered through the same mask as that used during the hypoxia conditions.
Transcranial Magnetic StimulationDevice
Also called TMS
Single- and paired-pulse TMS will be applied over the primary motor cortex (M1) to assess corticospinal excitability, along with intracortical inhibitory and facilitatory mechanisms. Motor-evoked potentials will be recorded from the abductor pollicis brevis (APB) muscle of the dominant hand.
| Study group | Role | What they receive |
|---|---|---|
| Normoxia | Sham comparator | The sham condition will consist of 30 minutes of continuous exposure to ambient air, inhaled through the same mask as that used during the hypoxia conditions. Receives: Device: Normoxia; Device: Transcranial Magnetic Stimulation |
| Continuous moderate hypoxia | Experimental | The duration of exposure to continuous hypoxia will be 30 minutes. A peripheral oxygen saturation (SpO₂) between 85% and 90% will be targeted. Hypoxic exposure will take place at rest, with the participant comfortably seated. In addition, the hypoxic device used in the study is equipped with a safety system allowing a minimum fraction of inspired oxygen (FiO₂) to be defined. This threshold will be set at 10%, ensuring that the FiO₂ cannot fall below this value. Receives: Device: Moderate hypoxia; Device: Transcranial Magnetic Stimulation |
| Intermittent moderate hypoxia | Experimental | The intermittent hypoxia condition will consist of six periods of 5 minutes of hypoxia interspersed with 5-minute periods of normoxia. During the hypoxic periods, a SpO₂ between 85% and 90% will be targeted. As in the continuous condition, hypoxic exposure will take place at rest, with the participant comfortably seated. The hypoxic device also includes a safety system allowing a minimum FiO₂ to be defined; this threshold will be set at 10%, ensuring that the FiO₂ cannot fall below this value. Receives: Device: Moderate hypoxia; Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrical brain activity
Electroencephalography (EEG) data will be recorded using a SAGA system (TMSi, Einsteinweg, The Netherlands). This system includes 64 Ag/AgCl pin-type electrodes. An additional electrode will be positioned on either the left or right mastoid. The primary outcome will be the variation in spectral power within the alpha frequency band.
Measured: Assessed throughout the intervention, at Day 2, 3, and 4 of the protocol.
Haemodynamic activity
A Brite system (Artinis, Einsteinweg, The Netherlands) will be used to collect functional near-infrared spectroscopy (fNIRS) data. The equipment comprises four LED emitters and four photodiode receivers. A nine-channel montage will be designed to cover the regions of interest, namely the dorsolateral prefrontal cortex, the ventromedial prefrontal cortex, and the anterior prefrontal cortex. The primary outcome will be the variation in deoxyhaemoglobin (HbR).
Measured: Assessed throughout the intervention, at Day 2, 3, and 4 of the protocol.
Secondary outcomes (3)
Corticospinal excitability
Corticospinal excitability will be assessed using transcranial magnetic stimulation (TMS) applied to the primary motor cortex. Motor evoked potentials (MEPs) are recorded using surface electromyography from the abductor pollicis brevis (APB) muscle of the dominant hand.The primary outcome will be the slope of the I/O curve.
Measured: Assessed at baseline and immediately post-intervention during each of the three experimental sessions (i.e., intermittent moderate hypoxia, continuous moderate hypoxia, normoxia).
EEG brain connectivity
Resting-state cortical connectivity will be examined using the EEG data, on which coherence analyses will be applied. The outcome measure will be the degree of functional connectivity between cortical regions, quantified through coherence values across specific frequency bands (e.g., alpha, beta), reflecting the synchronisation of neural activity between these regions.
Measured: Assessed throughout the intervention, at Day 2, 3, and 4 of the protocol.
fNIRS brain connectivity
Resting-state cortical connectivity will be examined using the fNIRS signals, through correlations of deoxyhaemoglobin (HbR) between the cortical regions of interest. The outcome measure will be the strength of functional connectivity between these regions, quantified by the correlation coefficients of haemodynamic fluctuations, reflecting the synchrony of cortical activity at rest.
Measured: Assessed throughout the intervention, at Day 2, 3, and 4 of the protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start15 Mar 2026
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NormoxiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universite du Littoral Cote d'Opale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516028
- Sponsor's protocol ID
- 2025-A02509-40
- Acronym
- NEUROXIE
- Status last verified
- Sep 2026
- First submitted
- 5 Mar 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Connectivity and Corticospinal Excitability in Response to Moderate Hypoxia
- ClinicalTrials.gov ID
- NCT07516028
- Acronym / sponsor ID
- NEUROXIE / 2025-A02509-40
- Keywords
- hypoxia, eeg, fnirs, motor-evoked potentials, tms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Universite du Littoral Cote d'OpaleUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 7 Apr 2026 (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.
Hypoxia, defined as a reduction in the availability of oxygen, induces significant physiological adaptations. While the deleterious effects of severe and chronic hypoxia are well documented, several studies indicate that moderate hypoxia - particularly when administered intermittently - may produce beneficial effects on cardiometabolic health (e.g., improved regulation of blood pressure and better glycaemic control). However, its impact on the dynamics of brain circuits in humans remains relatively underexplored. The present project aims to characterise the effects of continuous and intermittent moderate hypoxia on resting-state brain dynamics in healthy adults. To this end, simultaneous electroencephalography (EEG) and functional near-infrared spectroscopy (fNIRS) recordings will be conducted in order to extract functional and haemodynamic markers of brain activity. This project will contribute to a better understanding of the neurophysiological mechanisms associated with hypoxic conditioning and to the assessment of its potential application in innovative therapeutic approaches.
Detailed description
Hypoxia refers to a condition in which the availability of oxygen (O₂) is reduced relative to normal conditions. While severe hypoxia is well known for its deleterious effects, moderate hypoxia - particularly when administered intermittently - may produce potentially beneficial effects on cardiometabolic health, such as improved regulation of blood pressure and enhanced energy metabolism.
Animal models indicate that hypoxia can promote the expression of neurotrophic factors, stimulate neuroplasticity, and enhance cerebrovascular function. In humans, several studies suggest that intermittent hypoxia induces more pronounced cardiometabolic adaptations than continuous hypoxia and may improve certain cognitive functions in older adults. Recent findings also indicate that moderate hypoxia alters spontaneous brain activity at rest, particularly in the alpha frequency band, suggesting a possible influence on functional brain networks.
However, the effects of moderate hypoxia on resting-state brain dynamics remain poorly documented in humans. A detailed characterisation of both the electrical and haemodynamic responses of the brain is therefore required in order to better understand the potential adaptive processes involved and to evaluate the relevance of intermittent hypoxia as a non-pharmacological intervention for optimising brain health.
The primary objective of this project is to evaluate the effects of continuous and intermittent moderate hypoxia on resting-state brain dynamics in healthy individuals. To this end, simultaneous EEG and fNIRS recordings will be collected in order to extract functional markers of resting brain activity. A secondary objective is to investigate the impact of moderate hypoxia on brain connectivity and corticospinal excitability.
This is a single-centre exploratory descriptive study. Each participant will be assessed during three experimental sessions (i.e. intermittent hypoxia, continuous hypoxia, and normoxia) separated by at least one week and presented in a pseudo-randomised order. During the hypoxic periods, a peripheral oxygen saturation (SpO₂) between 85% and 90% will be targeted.
- Session A: exposure to continuous moderate hypoxia (30 minutes)
- Session B: exposure to intermittent moderate hypoxia (six cycles of 5 minutes of hypoxia followed by 5 minutes of normoxia)
- Session C: exposure to normoxia for 30 minutes
Participants will be fitted with a cap enabling the simultaneous recording of EEG activity and haemodynamic signals (via measurements of oxyhaemoglobin [HbO₂] and deoxyhaemoglobin [HbR] concentrations) using fNIRS. The activity of the first dorsal interosseous muscle of the dominant hand will be recorded using surface electromyography. During the recordings (i.e., hypoxia or normoxia exposure), participants will remain at rest, without any motor activity or specific cognitive stimulation.
Corticospinal excitability will be assessed using TMS before and after each hypoxic exposure period. For this purpose, we will measure the amplitude of motor-evoked potentials in the first dorsal interosseous muscle of the dominant hand following stimulation of the contralateral motor cortex using TMS at 120% of the resting motor threshold. This measure will be complemented by the assessment of the efficiency of three intracortical mechanisms that contribute to changes in the excitability of the primary motor cortex: short- and long-interval intracortical inhibition (SICI and LICI, respectively), as well as intracortical facilitation (ICF). These measures will be obtained using paired-pulse TMS protocols.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normoxia | Sham comparator | Device: Normoxia, Device: Transcranial Magnetic StimulationThe sham condition will consist of 30 minutes of continuous exposure to ambient air, inhaled through the same mask as that used during the hypoxia conditions. |
| Continuous moderate hypoxia | Experimental | Device: Moderate hypoxia, Device: Transcranial Magnetic StimulationThe duration of exposure to continuous hypoxia will be 30 minutes. A peripheral oxygen saturation (SpO₂) between 85% and 90% will be targeted. Hypoxic exposure will take place at rest, with the participant comfortably seated. In addition, the hypoxic device used in the study is equipped with a safety system allowing a minimum fraction of inspired oxygen (FiO₂) to be defined. This threshold will be set at 10%, ensuring that the FiO₂ cannot fall below this value. |
| Intermittent moderate hypoxia | Experimental | Device: Moderate hypoxia, Device: Transcranial Magnetic StimulationThe intermittent hypoxia condition will consist of six periods of 5 minutes of hypoxia interspersed with 5-minute periods of normoxia. During the hypoxic periods, a SpO₂ between 85% and 90% will be targeted. As in the continuous condition, hypoxic exposure will take place at rest, with the participant comfortably seated. The hypoxic device also includes a safety system allowing a minimum FiO₂ to be defined; this threshold will be set at 10%, ensuring that the FiO₂ cannot fall below this value. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged 18 to 65 years
- Healthy right- or left-handed individuals with no self-reported neurological disorders or history of neurological conditions (e.g., epilepsy, stroke, brain or spinal surgery, or neurological diseases affecting motor or sensory function such as multiple sclerosis, or neurodegenerative diseases such as Parkinson's or Alzheimer's)
- Individuals who have provided informed consent and have sufficient proficiency in French
- Participants affiliated with, or beneficiaries of, a social security scheme
Key exclusion criteria (10 listed)
- Body mass index (BMI) greater than 30 kg/m²
- Diagnosed and untreated obstructive sleep apnoea syndrome
- Inability to provide informed consent
- History of cardiac (e.g., ischaemic heart disease, heart failure) and/or respiratory disorders (e.g., COPD, chronic respiratory insufficiency, persistent or uncontrolled asthma)
- Current smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate hypoxiaAltitude conditions (normobaric hypoxia) will be reproduced using the OnePlus VA device (GO2Altitude, Biomedtech, Melbourne, Australia). This device modulates the fraction of inspired oxygen (FiO₂) through a patented semi-permeable membrane system developed by the company. It thereby produces a gas mixture that is inhaled by the participant through a mask. This device included an oxygen-reduction algorithm, that adjusts the FiO₂ in real time according to a target peripheral oxygen saturation (SpO₂ = 85-90%). | Device | Continuous moderate hypoxia, Intermittent moderate hypoxia |
| NormoxiaAmbient air will be delivered through the same mask as that used during the hypoxia conditions. | Device | Normoxia |
| Transcranial Magnetic StimulationAlso: TMSSingle- and paired-pulse TMS will be applied over the primary motor cortex (M1) to assess corticospinal excitability, along with intracortical inhibitory and facilitatory mechanisms. Motor-evoked potentials will be recorded from the abductor pollicis brevis (APB) muscle of the dominant hand. | Device | Continuous moderate hypoxia, Intermittent moderate hypoxia, Normoxia |
Primary outcome
Electrical brain activity
Time frame: Assessed throughout the intervention, at Day 2, 3, and 4 of the protocol.
Electroencephalography (EEG) data will be recorded using a SAGA system (TMSi, Einsteinweg, The Netherlands). This system includes 64 Ag/AgCl pin-type electrodes. An additional electrode will be positioned on either the left or right mastoid. The primary outcome will be the variation in spectral power within the alpha frequency band.
Haemodynamic activity
Time frame: Assessed throughout the intervention, at Day 2, 3, and 4 of the protocol.
A Brite system (Artinis, Einsteinweg, The Netherlands) will be used to collect functional near-infrared spectroscopy (fNIRS) data. The equipment comprises four LED emitters and four photodiode receivers. A nine-channel montage will be designed to cover the regions of interest, namely the dorsolateral prefrontal cortex, the ventromedial prefrontal cortex, and the anterior prefrontal cortex. The primary outcome will be the variation in deoxyhaemoglobin (HbR).
3 secondary outcomes
Corticospinal excitability
Time frame: Assessed at baseline and immediately post-intervention during each of the three experimental sessions (i.e., intermittent moderate hypoxia, continuous moderate hypoxia, normoxia).
EEG brain connectivity
Time frame: Assessed throughout the intervention, at Day 2, 3, and 4 of the protocol.
fNIRS brain connectivity
Time frame: Assessed throughout the intervention, at Day 2, 3, and 4 of the protocol.
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 21 Sep 2026.
- Individual participant dataSharing planned: No
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Normobaric Hypoxia as a Strength Training Intensity Amplifier in Ice Hockey Players: Effects on Anaerobic Performance and Muscle Contraction Properties
High-intensity Strenght Training in Normoxia (H-N), Low-intensity Strenght Training in Normoxia (L-N)
Active, not recruitingPhase 3
Strategy to Avoid Excessive Oxygen in Major Burn Patients
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate hypoxia, Normoxia and Transcranial Magnetic Stimulation in people with Normoxia and Intermittent Moderate Hypoxia, run by Universite du Littoral Cote d'Opale at 1 site in France.
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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Ségolène M. R. Guérin, PhD (+33 3 74 00 82 13, segolene.guerin@univ-littoral.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrical brain activity (time frame: Assessed throughout the intervention, at Day 2, 3, and 4 of the protocol.). 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?
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 21 Sep 2026.