Brain TumorsBRAIN-TIMENCT04128306
Brain Areas of Time-To-Contact Perception: an Awake Surgery Study
A study testing Behavioral task, Awake surgery and Neurological assessment in people with Brain Tumors, run by University Hospital, Toulouse at 1 site in France.
Trial summary
During a brain surgery targeted to remove a brain tumor, the neurosurgeon wakes up the patient to delimit the tumor area exactly, and identify the surrounding areas, to limit the surgery damages. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Tumors
- What is being tested?
- Behavioral task, Awake surgery and Neurological assessment
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2019to 29 Jan 2025
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For the patients:
- Brain tumor that does not affect the dominant hand motricity. The patient that have a tumor in an area targeted for a cortical stimulation will be automatically enrolled within the Pre-End group.
- Who will agree with all terms and sign the experimental agreement
- Correct or corrected vision, as allowed by the surgery constraints
- With no known oculomotor abnormalities (list of exclusion in Annexe)
- Affiliated to a social security system
Show all 11Show fewer
- For the control group:
- Who will agree with all terms and sign the experimental agreement
- Correct or corrected vision
- With no known oculomotor abnormalities.
- Affiliated to a social security system
Who cannot join
- For the patients:
- Brain tumor located in the occipital area
- Legally protected patient, or with unknown ability to sign the experimental agreement, as determined by the medical team.
- Medical background of neurological diseases of the central nervous system, as Parkinson, Alzheimer, stroke
- Pregnancy
- For the control group:
Show all 9Show fewer
- Legally protected patient, or with unknown ability to sign the experimental agreement, as determined by the medical team.
- Medical background of neurological diseases of the central nervous system, as Parkinson, Alzheimer, stroke
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Localizing in the Brain the Areas of Time to Contact Perception During an Awake Surgery
During a brain surgery targeted to remove a brain tumor, the neurosurgeon wakes up the patient to delimit the tumor area exactly, and identify the surrounding areas, to limit the surgery damages. The present project aims at testing the patient in this awake phase to determine the brain areas implied in time to contact (TTC) perception, a function that allows determining the arrival time of moving objects and used in many tasks of our daily life.
Read the detailed description
Time to contact (TTC) estimation is a major visual function that allows an observer determining the time a moving object will take to reach him. It is however striking to note that the different brain areas supporting this function are not clearly identified, in particular the contribution of non-visual areas that are engaged in the definition of a peri-personal space for the observer. This lack could be fulfilled during a brain surgery experiment. Indeed, in such a surgery, the patient is awakened, and the surgeon apply direct cortical stimulation to de-activate specific brain areas while testing different cognitive function. The failure to succeed in the task indicates that this area is engaged in the cognitive function. The present study therefore will test different brain areas to investigate their respective contribution in the TTC estimation function.
Three groups of participants will be tested, in pre and per surgery phases. After an initial pre-surgery phase, patients for which the tumor does not interfere with the TTC estimation anility will be enrolled in the Pré-Per group, and tested during the brain surgery. Patients for which the pre-test indicates that the TTC estimation is damaged by the tumor, will be tested in pre-surgery phase only, constituting the Pré-End group. Finally, a control group, paired with the patients, will be tested as well.
For the patients, all the testing phases will be achieved during their medical process. The awake surgery is now a well-established technique, currently and usually done at the University Hospital Toulouse, and the present test in the per surgery phase only lasts a couple of minutes, no more than 5 minutes. As such, there is no additional risk carried out in the project.
- Conditions
- Brain Tumors
- Being tested
- Behavioral task, Awake surgery, Neurological assessment
- Keywords
- Time to contact estimation, awake brain surgery, brain tumor, cerebral mapping
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral taskBehavioural
In the task, participants will see an object approaching toward them. During its movement, the object disappears, and the participants have to press a button to indicate when they estimate the object to contact with them. The motion parameters of the ball will be varied. The pre and post-surgery phases will test the participants in a long duration version of the task, approximately 30 minutes. The per surgery phase will be made of a 5 minutes version of the task, and the participants will receive a direct cortical stimulation for 4 seconds, at an intensity of 1 to 10 milliampere (mA), in the premotor ventral area, or posterior parietal cortex or somesthetic associative areas.
Awake surgeryProcedure or surgery
The patient is first anesthetized for opening the scalp and skull, then awake. During this waking phase, the surgeon passes a few quick and simple tests to the patient, visual (for example, line bisection), language (for example, repeating a list of words) etc. While doing this task, the neurosurgeon disrupts the functioning of certain brain regions by direct electrical stimulation of the cortex in order to identify the regions whose dysfunction will have an impact on the current task.
During the operation, the areas involved in the construction of the peri-personal space will be stimulated by direct electrical stimulation, for a duration of 4 seconds at an intensity of 1 to 10 mA. These areas are:
- Ventral premotor cortex (with the exception of the primary motor cortex controlling the dominant hand, so as not to interfere with the motor response of the patient)
- Posterior parietal cortex
- Associative somesthetic areas
Neurological assessmentOther
The Mini Mental State Evaluation, which generally assesses the cognitive state of an individual through his 6 subtests testing both working memory, episodic and semantic praxies as well as spatio-temporal orientation capacity.
Neurological assessmentOther
The Wechsler Adult Intelligence Scale was selected for two of its subtests: The Subtest Codes checking the processing of information, visuo-constructive abilities but also attention. The subtest Cubes evaluates the capacities of visuospatial and constructive organizations as well as the referencing of the space in relation to the subject.
Neurological assessmentOther
The State-Trait Anxiety Inventory, consisting of two self-administered questionnaires: Questionnaire A, measuring the state of anxiety of the person on the present moment and B measuring anxiety as a character trait of the person
Neurological assessmentOther
The Verbal Fluences test, in its oral version. Categorial and lexical fluences make it possible to quickly realize a possible lack of the word of the person as well as disturbances of working memory or the capacity of inhibition.
Neurological assessmentOther
The board of the Corsi cubes that evaluates the non-verbal visual-spatial working memory of the participants with a reminder location that tests the visuo-spatial notebook and a reminder to who tests the central administrator of the working memory.
Neurological assessmentOther
The neurocognitive naming test was chosen to verify correct access to both semantic memory and lexicon, as well as to test the early visual process of image processing necessary for our task.
Neurological assessmentOther
Benton lines are commonly used to determine possible deficits in the localization of isolated objects or judgment of line direction.
Neurological assessmentOther
The patient will finally pass a depression assessment test, answering Beck's questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Experimental | A total of 120 patients with brain tumors will be divided into our two groups, divided as follows:
1. In the group Pre-Per, 20 patients will be included by localization of electrical stimulation (60 patients in total). A patient who would be stimulable in two different areas could be included in two different groups.
2. In the group Pre-End, the subjects will be distributed by localization of the brain tumor, by lobe. A total of 20 participants will be included per lobe, corresponding to the frontal, temporal or parietal lobes (as a reminder, a tumor in the occipital lobe is an exclusion criterion), for a total of 60 participants Receives: Behavioral: Behavioral task; Procedure: Awake surgery; Other: Neurological assessment |
| Control group | Active comparator | A maximum of 120 healthy matched sex and age subjects with patients will also be included Receives: Behavioral: Behavioral task; Other: Neurological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral mapping
Look at how the cognitive functions of perception of time before contact are attached to brain structures, their communication with other zones, their alteration due to brain tumors for patients with a brain tumor compared to control subjects. The treatment of the study being an awakened awakening as part of the routine care, there is no risk of serious adverse event.
Brain mapping will be done through neurological examinations which are questionnaires and a risk-free task. All the tasks and all the questionnaires described in the paragraph "arm and intervention" will make it possible to meet this outcome.
Measured: 61 months
Secondary outcomes (1)
Look the implication of other brain areas
Look to see if brain areas other than those targeted for stimulation in awake surgery are stimulated and therefore play a role in estimating time to contact.The treatment of the study being an awakened awakening as part of the routine care, there is no risk of serious adverse event.
Other brain areas will be define through neurological examinations which are questionnaires and a risk-free task. All the tasks and the questionnaires described in the paragraph "arm and intervention" will make it possible to meet this outcome.
Measured: 61 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start16 Sep 2019
- Primary completion29 Jan 2025
- Study completion29 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franck-Emmanuel Roux, MD, Principal investigator, University Hopsital Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128306
- Sponsor's protocol ID
- RC31/18/0240
- Acronym
- BRAIN-TIME
- Status last verified
- Jun 2026
- First submitted
- 9 Oct 2019
- Last updated
- 9 Jun 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 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localizing in the Brain the Areas of Time to Contact Perception During an Awake Surgery
- ClinicalTrials.gov ID
- NCT04128306
- Acronym / sponsor ID
- BRAIN-TIME / RC31/18/0240
- Conditions
- Brain Tumors
- Keywords
- Time to contact estimation, awake brain surgery, brain tumor, cerebral mapping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 29 Jan 2025 (actual)
- Study completion
- 29 Jan 2025 (actual)
- First posted
- 16 Oct 2019 (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.
During a brain surgery targeted to remove a brain tumor, the neurosurgeon wakes up the patient to delimit the tumor area exactly, and identify the surrounding areas, to limit the surgery damages. The present project aims at testing the patient in this awake phase to determine the brain areas implied in time to contact (TTC) perception, a function that allows determining the arrival time of moving objects and used in many tasks of our daily life.
Detailed description
Time to contact (TTC) estimation is a major visual function that allows an observer determining the time a moving object will take to reach him. It is however striking to note that the different brain areas supporting this function are not clearly identified, in particular the contribution of non-visual areas that are engaged in the definition of a peri-personal space for the observer. This lack could be fulfilled during a brain surgery experiment. Indeed, in such a surgery, the patient is awakened, and the surgeon apply direct cortical stimulation to de-activate specific brain areas while testing different cognitive function. The failure to succeed in the task indicates that this area is engaged in the cognitive function. The present study therefore will test different brain areas to investigate their respective contribution in the TTC estimation function.
Three groups of participants will be tested, in pre and per surgery phases. After an initial pre-surgery phase, patients for which the tumor does not interfere with the TTC estimation anility will be enrolled in the Pré-Per group, and tested during the brain surgery. Patients for which the pre-test indicates that the TTC estimation is damaged by the tumor, will be tested in pre-surgery phase only, constituting the Pré-End group. Finally, a control group, paired with the patients, will be tested as well.
For the patients, all the testing phases will be achieved during their medical process. The awake surgery is now a well-established technique, currently and usually done at the University Hospital Toulouse, and the present test in the per surgery phase only lasts a couple of minutes, no more than 5 minutes. As such, there is no additional risk carried out in the project.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | Experimental | Behavioral: Behavioral task, Procedure: Awake surgery, Other: Neurological assessmentA total of 120 patients with brain tumors will be divided into our two groups, divided as follows: 1. In the group Pre-Per, 20 patients will be included by localization of electrical stimulation (60 patients in total). A patient who would be stimulable in two different areas could be included in two different groups. 2. In the group Pre-End, the subjects will be distributed by localization of the brain tumor, by lobe. A total of 20 participants will be included per lobe, corresponding to the frontal, temporal or parietal lobes (as a reminder, a tumor in the occipital lobe is an exclusion criterion), for a total of 60 participants |
| Control group | Active comparator | Behavioral: Behavioral task, Other: Neurological assessmentA maximum of 120 healthy matched sex and age subjects with patients will also be included |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Brain tumor that does not affect the dominant hand motricity. The patient that have a tumor in an area targeted for a cortical stimulation will be automatically enrolled within the Pre-End group.
- Who will agree with all terms and sign the experimental agreement
- Correct or corrected vision, as allowed by the surgery constraints
- With no known oculomotor abnormalities (list of exclusion in Annexe)
- Affiliated to a social security system
Key exclusion criteria (9 listed)
- Brain tumor located in the occipital area
- Legally protected patient, or with unknown ability to sign the experimental agreement, as determined by the medical team.
- Medical background of neurological diseases of the central nervous system, as Parkinson, Alzheimer, stroke
- Pregnancy
- Legally protected patient, or with unknown ability to sign the experimental agreement, as determined by the medical team.
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 |
|---|---|---|
| Behavioral taskIn the task, participants will see an object approaching toward them. During its movement, the object disappears, and the participants have to press a button to indicate when they estimate the object to contact with them. The motion parameters of the ball will be varied. The pre and post-surgery phases will test the participants in a long duration version of the task, approximately 30 minutes. The per surgery phase will be made of a 5 minutes version of the task, and the participants will receive a direct cortical stimulation for 4 seconds, at an intensity of 1 to 10 milliampere (mA), in the premotor ventral area, or posterior parietal cortex or somesthetic associative areas. | Behavioural | Control group, Patient group |
| Awake surgeryThe patient is first anesthetized for opening the scalp and skull, then awake. During this waking phase, the surgeon passes a few quick and simple tests to the patient, visual (for example, line bisection), language (for example, repeating a list of words) etc. While doing this task, the neurosurgeon disrupts the functioning of certain brain regions by direct electrical stimulation of the cortex in order to identify the regions whose dysfunction will have an impact on the current task. During the operation, the areas involved in the construction of the peri-personal space will be stimulated by direct electrical stimulation, for a duration of 4 seconds at an intensity of 1 to 10 mA. These areas are: * Ventral premotor cortex (with the exception of the primary motor cortex controlling the dominant hand, so as not to interfere with the motor response of the patient) * Posterior parietal cortex * Associative somesthetic areas | Procedure or surgery | Patient group |
| Neurological assessmentThe Mini Mental State Evaluation, which generally assesses the cognitive state of an individual through his 6 subtests testing both working memory, episodic and semantic praxies as well as spatio-temporal orientation capacity. | Other | Control group, Patient group |
| Neurological assessmentThe Wechsler Adult Intelligence Scale was selected for two of its subtests: The Subtest Codes checking the processing of information, visuo-constructive abilities but also attention. The subtest Cubes evaluates the capacities of visuospatial and constructive organizations as well as the referencing of the space in relation to the subject. | Other | Control group, Patient group |
| Neurological assessmentThe State-Trait Anxiety Inventory, consisting of two self-administered questionnaires: Questionnaire A, measuring the state of anxiety of the person on the present moment and B measuring anxiety as a character trait of the person | Other | Control group, Patient group |
| Neurological assessmentThe Verbal Fluences test, in its oral version. Categorial and lexical fluences make it possible to quickly realize a possible lack of the word of the person as well as disturbances of working memory or the capacity of inhibition. | Other | Control group, Patient group |
| Neurological assessmentThe board of the Corsi cubes that evaluates the non-verbal visual-spatial working memory of the participants with a reminder location that tests the visuo-spatial notebook and a reminder to who tests the central administrator of the working memory. | Other | Control group, Patient group |
| Neurological assessmentThe neurocognitive naming test was chosen to verify correct access to both semantic memory and lexicon, as well as to test the early visual process of image processing necessary for our task. | Other | Control group, Patient group |
| Neurological assessmentBenton lines are commonly used to determine possible deficits in the localization of isolated objects or judgment of line direction. | Other | Control group, Patient group |
| Neurological assessmentThe patient will finally pass a depression assessment test, answering Beck's questionnaire. | Other | Control group, Patient group |
Primary outcome
Cerebral mapping
Time frame: 61 months
Look at how the cognitive functions of perception of time before contact are attached to brain structures, their communication with other zones, their alteration due to brain tumors for patients with a brain tumor compared to control subjects. The treatment of the study being an awakened awakening as part of the routine care, there is no risk of serious adverse event. Brain mapping will be done through neurological examinations which are questionnaires and a risk-free task. All the tasks and all the questionnaires described in the paragraph "arm and intervention" will make it possible to meet this outcome.
1 secondary outcome
Look the implication of other brain areas
Time frame: 61 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- 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. This study is not recruiting at the moment.
Franck-Emmanuel Roux, MD principal investigator
University Hopsital Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral task, Awake surgery and Neurological assessment in people with Brain Tumors, run by University Hospital, Toulouse 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 11 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cerebral mapping (time frame: 61 months). 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.