SARS-CoV 2BRAINCOVNCT04405986
Exploring Brain Damages After COVID-19 Infection
A study testing Auditory Evoked Potentials (AEP) and Blink and Masseter Inhibitory Reflex in people with SARS-CoV 2, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Although direct evidence is currently lacking, the high identity between SARS-CoV-1 and SARS-CoV-2 suggests, that the latter viral strain could also infect the Central Nervous System (CNS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV 2
- What is being tested?
- Auditory Evoked Potentials (AEP) and Blink and Masseter Inhibitory Reflex
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2020to 10 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Hospitalized patient suffering from a positive COVID 19 diagnosed by Reverse transcription polymerase chain reaction (RT-PCR) or chest computed tomography scan (CTscan) with specific lesions
Who cannot join
- History of neurological damage interfering with auditory evoked potentials (PEA) and Electromyography (EMG) reflexes of the brainstem (stroke of the brainstem, acoustic neuroma, amyotrophic lateral sclerosis, facial diplegia, damage to nerves V or VII, etc.)
- Impaired alertness
- Sedative treatments or treatments that disturb nerve conduction.
- Pregnancy or breastfeeding
- Individuals under legal protection or unable to express personally their consent
Trial locations and contacts
1 site in 1 country.
About this study
Although direct evidence is currently lacking, the high identity between SARS-CoV-1 and SARS-CoV-2 suggests, that the latter viral strain could also infect the Central Nervous System (CNS). Indeed, some cases of SARS-COV2 encephalitis begin to be described and CNS damages are increasingly highlighted in the literature, but still not objectified by imaging and do not allow to explain the entire clinical patterns. We hypothesise that these CNS damages are not always objectified by Magnetic Resonance Imaging (MRI) but could be indirectly observed by a physiological dysfunction of neural conduction in the brainstem. We will explore brainstem disruption through an electrophysiological approach.
Read the detailed description
Clinical and preclinical data from studies with other coronaviruses suggest an evident neurotropism, which may result in more complex clinical scenarios. Can the SARS-CoV-2 enter the Central Nervous System (CNS) and infect neural cells ? And if yes, how the CNS damage contributes to pathophysiology of the COVID-19, to its signs, symptoms and progression as well as to its sequelae. It has been demonstrated that coronaviruses such as SARS-CoV and MERS-CoV do not limit their presence to the respiratory tract and frequently invade the CNS. The intranasal administration of SARS-CoV-1 or MERS-COV resulted in the rapid invasion of viral particles into the brain of mice, possibly through the olfactory bulb via trans-synaptic route. The brainstem, which hosts the respiratory neuronal circuit in the medulla, was severely infected with both types of viruses, which may contribute to degradation and failure of respiratory centres.
- Conditions
- SARS-CoV 2
- Being tested
- Auditory Evoked Potentials (AEP), Blink and Masseter Inhibitory Reflex
- Keywords
- COVID-19, Brainstem, Electrophysiology
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory Evoked Potentials (AEP)Procedure or surgery
Record of electrophysiological responses (Auditory Evoked Potentials or AEP) during auditory stimulations with an electroencephalogram (EEG).
Blink and Masseter Inhibitory ReflexProcedure or surgery
Electrophysiological exploration while stimulating trigeminal nerve to record 1) motor response induced (muscle contraction delay (Blink)) of the facial nerve, or 2) the contraction inhibition of masseters (Masseter Inhibitory Reflex (MIR)).
| Study group | Role | What they receive |
|---|---|---|
| Electrophysiological procedure | Experimental | Brainstem reflexes and neural conduction will be explored using Auditory Evoked Potentials (AEP) and blink and Masseter Inhibitory Reflex (MIR) in hospitalised patients with COVID infection Receives: Procedure: Auditory Evoked Potentials (AEP); Procedure: Blink and Masseter Inhibitory Reflex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency of electrophysiological response
Latencies of electrophysiological responses with Auditory Evoked Potentials
Measured: Inclusion (T0)
Delay of Muscle contraction
Delay of Muscle contraction (Blink reflex)
Measured: Inclusion (T0)
Delay of silent period
Delay of silent period while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)
Measured: Inclusion (T0)
Duration of silent period
Duration of silent period while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)
Measured: Inclusion (T0)
Inhibition rate
Inhibition rate while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)
Measured: Inclusion (T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start19 May 2020
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
Why it stopped: Target number of inclusion not reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV 2Studies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand Glize, Principal investigator, bertrand.glize@chu-bordeaux.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405986
- Sponsor's protocol ID
- CHUBX 2020/20
- Other IDs
- 2020-A01268-31
- Acronym
- BRAINCOV
- Status last verified
- Apr 2021
- First submitted
- 8 May 2020
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Brain Damages After COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04405986
- Acronym / sponsor ID
- BRAINCOV / CHUBX 2020/20
- Conditions
- SARS-CoV 2
- Keywords
- COVID-19, Brainstem, Electrophysiology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Target number of inclusion not reached
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 19 May 2020 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 28 May 2020 (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.
Although direct evidence is currently lacking, the high identity between SARS-CoV-1 and SARS-CoV-2 suggests, that the latter viral strain could also infect the Central Nervous System (CNS). Indeed, some cases of SARS-COV2 encephalitis begin to be described and CNS damages are increasingly highlighted in the literature, but still not objectified by imaging and do not allow to explain the entire clinical patterns. We hypothesise that these CNS damages are not always objectified by Magnetic Resonance Imaging (MRI) but could be indirectly observed by a physiological dysfunction of neural conduction in the brainstem. We will explore brainstem disruption through an electrophysiological approach.
Detailed description
Clinical and preclinical data from studies with other coronaviruses suggest an evident neurotropism, which may result in more complex clinical scenarios. Can the SARS-CoV-2 enter the Central Nervous System (CNS) and infect neural cells ? And if yes, how the CNS damage contributes to pathophysiology of the COVID-19, to its signs, symptoms and progression as well as to its sequelae. It has been demonstrated that coronaviruses such as SARS-CoV and MERS-CoV do not limit their presence to the respiratory tract and frequently invade the CNS. The intranasal administration of SARS-CoV-1 or MERS-COV resulted in the rapid invasion of viral particles into the brain of mice, possibly through the olfactory bulb via trans-synaptic route. The brainstem, which hosts the respiratory neuronal circuit in the medulla, was severely infected with both types of viruses, which may contribute to degradation and failure of respiratory centres.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrophysiological procedure | Experimental | Procedure: Auditory Evoked Potentials (AEP), Procedure: Blink and Masseter Inhibitory ReflexBrainstem reflexes and neural conduction will be explored using Auditory Evoked Potentials (AEP) and blink and Masseter Inhibitory Reflex (MIR) in hospitalised patients with COVID infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years.
- Hospitalized patient suffering from a positive COVID 19 diagnosed by Reverse transcription polymerase chain reaction (RT-PCR) or chest computed tomography scan (CTscan) with specific lesions
Key exclusion criteria (5 listed)
- History of neurological damage interfering with auditory evoked potentials (PEA) and Electromyography (EMG) reflexes of the brainstem (stroke of the brainstem, acoustic neuroma, amyotrophic lateral sclerosis, facial diplegia, damage to nerves V or VII, etc.)
- Impaired alertness
- Sedative treatments or treatments that disturb nerve conduction.
- Pregnancy or breastfeeding
- Individuals under legal protection or unable to express personally their consent
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 |
|---|---|---|
| Auditory Evoked Potentials (AEP)Record of electrophysiological responses (Auditory Evoked Potentials or AEP) during auditory stimulations with an electroencephalogram (EEG). | Procedure or surgery | Electrophysiological procedure |
| Blink and Masseter Inhibitory ReflexElectrophysiological exploration while stimulating trigeminal nerve to record 1) motor response induced (muscle contraction delay (Blink)) of the facial nerve, or 2) the contraction inhibition of masseters (Masseter Inhibitory Reflex (MIR)). | Procedure or surgery | Electrophysiological procedure |
Primary outcome
Latency of electrophysiological response
Time frame: Inclusion (T0)
Latencies of electrophysiological responses with Auditory Evoked Potentials
Delay of Muscle contraction
Time frame: Inclusion (T0)
Delay of Muscle contraction (Blink reflex)
Delay of silent period
Time frame: Inclusion (T0)
Delay of silent period while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)
Duration of silent period
Time frame: Inclusion (T0)
Duration of silent period while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)
Inhibition rate
Time frame: Inclusion (T0)
Inhibition rate while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)
Results and safety
The study was stopped early (reason given: Target number of inclusion not reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
Related trials for SARS-CoV 2
Not yet recruiting
Effect of MxA Guidance on Antiviral Treatment in Respiratory Viral Infections
Respiratory Viral Infections, Influenza
Recruiting
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
COVID-19, Long COVID
Active, not recruiting
Clinical Validation of the NowFuture Digital Flu / COVID Test in Anterior Nasal Samples for Over-the-Counter (OTC) Use in Australia
SARS CoV 2 Infection, Influenza A Virus Infection
RecruitingObservational study
Determinants of SARS (Severe Acute Respiratory Syndrome)-COV2 (COVID-19) Persistence After Convalescence
COVID-19, Corona Virus Infection
Recruiting
Exercise in Child Health
Cystic Fibrosis, Sickle Cell Disease
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. This study is not recruiting at the moment.
Bertrand Glize principal investigator
bertrand.glize@chu-bordeaux.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory Evoked Potentials (AEP) and Blink and Masseter Inhibitory Reflex in people with SARS-CoV 2, run by University Hospital, Bordeaux 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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 9 Jun 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. 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?
The study was stopped early (reason given: Target number of inclusion not reached). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latency of electrophysiological response (time frame: Inclusion (T0)). The study lists 5 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 9 Jun 2026.