Brain DamageNCT04419818
A Neuropsychological Test Battery for the Assessment of Time Deficits
An observational study of Brain Damage and Health Behavior, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
Time processing involves different abilities - i.e. estimating the duration of an event and moving in past and future time - and it is a fundamental ability in everyday life. For these reasons the assessment and the rehabilitation of time deficits in brain damaged patients is extremely important. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Damage, Health Behavior
- What is being tested?
- Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 96 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2019to 13 Jan 2023
- Phase
- Observational
- 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 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be selected from primary care clinic and they will be compared with matched healthy controls. Healthy controls will be selected from a community sample who volunteer to participate in the research.
Who may be able to join
- patients with focal right and left brain-damage
Who cannot join
- generalized cognitive impairment (score lower than 24 at the Mini Mental State Examination)
- psychiatric disorders
- additional neurological disorders
- abusive use of alcohol or illicit drugs
Trial locations and contacts
1 site in 1 country.
Italy1 site
ICS Maugeri IRCCS, U.O. di Rieducazione e Recupero funzionale di Castel Goffredo
Castel Goffredo, Mantova, 46042
About this study
Official title: A Neuropsychological Test Battery for the Assessment of Time Deficits in Brain-damaged Patients: a Correlation Study
Time processing involves different abilities - i.e. estimating the duration of an event and moving in past and future time - and it is a fundamental ability in everyday life. For these reasons the assessment and the rehabilitation of time deficits in brain damaged patients is extremely important.
The ability to estimate and reproduce time processing is usually evaluated using computerized tasks and it is influenced by aging: young participants overestimate and elderly participants underestimate time durations.
Virtual Reality is an ecological approach that has recently been used for the assessment of cognitive deficits. Here we use Virtual Reality to study the ability to estimate time duration of an action execution and perception in a simulated everyday activity.
Read the detailed description
Time processing involves different abilities - i.e. estimating the duration of an event and moving in past and future time - and it is a fundamental ability in everyday life. However, in neuropsychology, time processing is routinely neglected in the assessment of cognitive deficits in brain-damaged patients. The discrepancy between the importance of time processing and the lack of instruments for the diagnosis of time deficits in brain damaged patients can be mainly due to the fact that time difficulties fail to emerge in a hospital context where daily activities are routinely scheduled by careers. Thus, time deficits become critical only when patients return home and, for younger patients, when they go back to working activities. For these reasons the assessment and the rehabilitation of time deficits in brain damaged patients is extremely important.
Interestingly, recent evidence has begun to demonstrate that our perceptions and sensations are influenced by motor movements and actions. Further, there is also evidence suggesting that movement not only biases perceived time, but can enhance it, suggesting the motor system directly influences temporal perception.
The ability to estimate and reproduce time in actions is usually evaluated using computerized tasks and it is influenced by aging: young participants overestimate and elderly participants underestimate time durations.
Virtual Reality is an ecological approach that has recently been used for the assessment of cognitive deficits. Here we use Virtual Reality to study the ability to estimate time duration of an action execution and perception in a simulated everyday activity.
The primary aim of the project is to measure the impact of time deficits and its effects on everyday life: a neuropsychological battery assessing time processing (Time Estimation, Time Reproduction, Mental Time Travel) is tested using both computerized and virtual reality tasks.
Moreover, the project aims also to investigate i) the correlation between Time Reproduction in a computerized task and the ability to reproduce the duration of an executed action in Virtual Reality; ii) the correlation between Time Estimation in a computerized task and the ability to estimate the duration of an executed action in Virtual Reality.
- Conditions
- Brain Damage, Health Behavior
- Being tested
- Virtual Reality
- Keywords
- Time perception, Mental Time Travel, Virtual Reality
- Medical subject headings
- Brain Injuries, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityBehavioural
Virtual Reality task consists of a 3D computer-generated virtual environment that will be displayed on a desktop VR computer monitor. A joystick will provide the graphical interface for patients by allowing user-friendly exploration of virtual scenarios. Participants will be presented 16 actions, with dynamic simulations of real life situations. They will verbally estimate and reproduce the duration of each previously presented action.
| Study group | Role | What they receive |
|---|---|---|
| Left brain damaged patients | A group of 20 left brain damaged (LBD) patients will perform:
* a computerized test battery to measure time abilities (Mental Time Travel, Time Estimation and Time Reproduction);
* a neuropsychological screening (Mini Mental State Examination and Token Test) to assess inclusion/exclusion criteria;
* questionnaires to evaluate the time needed to execute actions and the ability to locate daily activities in time. Receives: Behavioral: Virtual Reality | |
| Right brain damaged patients | A group of 20 right brain damaged (RBD) patients will perform:
* a computerized test battery to measure time abilities (Mental Time Travel, Time Estimation and Time Reproduction);
* a neuropsychological screening (Mini Mental State Examination and Token Test) to assess inclusion/exclusion criteria;
* questionnaires to evaluate the time needed to execute actions and the ability to locate daily activities in time. Receives: Behavioral: Virtual Reality | |
| Healthy controls | A group of 40 (20 young and 20 elderly) healthy controls (HC) will perform:
* a computerized test battery to measure time abilities (Mental Time Travel, Time Estimation and Time Reproduction);
* a neuropsychological screening (Mini Mental State Examination) to assess inclusion/exclusion criteria;
* questionnaires to evaluate the time needed to execute actions and the ability to locate daily activities in time. Receives: Behavioral: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Mental Time Travel Ability on the Mental Time Travel (MTT) Task
In the MTT task participants are listened to auditory stimuli consisting of brief descriptions of personal and non-personal events. They are required to project themselves in the past (10 years ago), present or future (10 years from now) and to verbally determine whether each event has already happened (relative past event) or is yet to happen (relative future event) with respect to the specific self-location in time (past, present and future).
Error rates and reaction times will be recorded and analyzed.
Measured: baseline
Assessment of Time Estimation Ability on the Time Estimation Task - long intervals
The Time Estimation task consists of a red square that is displayed for different durations (3500, 5500, 7500, 9500, 11500 ms) on the computer screen. Participants are instructed to verbally judge whether the duration of each stimulus is "short" or "long" with respect to previously acquired pair of reference durations (3500 and 11500 ms).
A psychophysical response function will be created for each participant by calculating the proportion of "long" responses: the Point of Subjective Equality (PSE) is the duration at which a participant is equally likely to classify the stimuli as short or long. Lower PSE reflects a relative shift towards overestimation of temporal midpoint. Conversely, higher PSE reflects a relative shift towards underestimation of temporal midpoint.
Measured: baseline
Assessment of Time Estimation Ability on the Time Estimation Task - short intervals
The Time Estimation task consists of a red square that is displayed for different durations (1400, 1700, 2000, 2300, 2600 ms) on the computer screen. Participants are instructed to verbally judge whether the duration of each stimulus is "short" or "long" with respect to previously acquired pair of reference durations (1400 and 2600 ms).
A psychophysical response function will be created for each participant by calculating the proportion of "long" responses: the Point of Subjective Equality (PSE) is the duration at which a participant is equally likely to classify the stimuli as short or long. Lower PSE reflects a relative shift towards overestimation of temporal midpoint. Conversely, higher PSE reflects a relative shift towards underestimation of temporal midpoint.
Measured: baseline
Assessment of Time Reproduction Ability on the Time Reproduction Task - long intervals
In the Time Reproduction task a blue square is presented for a variable time interval (3500, 5500, 7500, 9500, 11500 ms) on the computer screen. Next, a red square appears on the screen and participants are instructed to reproduce the entire duration of the preceding blue square by pressing the space bar on the keyboard.
The reproduced time intervals will be compared to the real ones: the difference will be positive when reproduced time will be longer (underestimation of time duration) and negative when reproduced time will be shorter (overestimation of time duration) than the real one.
Measured: baseline
Assessment of Time Reproduction Ability on the Time Reproduction Task - short intervals
In the Time Reproduction task a blue square is presented for a variable time interval (1400, 1700, 2000, 2300, 2600 ms) on the computer screen. Next, a red square appears on the screen and participants are instructed to reproduce the entire duration of the preceding blue square by pressing the space bar on the keyboard.
The reproduced time intervals will be compared to the real ones: the difference will be positive when reproduced time will be longer (underestimation of time duration) and negative when reproduced time will be shorter (overestimation of time duration) than the real one.
Measured: baseline
Secondary outcomes (6)
Assessment of Verbal Estimation Ability on the Time and Weight Estimation Test (STEP)
The STEP assesses aspects of executive functioning related to cognitive estimation ability. The questionnaire is composed of two distinct ten-item sections, focusing on time (e.g., How long does it take to have a shower?) and weight (e.g., How heavy is a pair of jeans?) estimations. Each item scores from 0 (bizarre estimation) to 3 (best estimation), for a total maximum score for each section of 30, with a cut-off value for normality above 20 for each section.
Measured: baseline
Assessment of Verbal Estimation Ability on the Cognitive Estimation Task (CET)
The test comprised 21 questions requiring participants to give oral, numerical responses. Two different scoring procedures will be considered: absolute error score and bizarreness. The total score for all 21 items ranges from a best of zero to a worst of 42. The greater the error score, the poorer the performance on the CET (cut-off = 18). The total bizarreness score ranges from 0 and 21 (cu-off = 4). The higher the bizarreness score, the greater the impairment in cognitive estimation.
Measured: baseline
Assessment of Functional Abilities on the Questionnaire of Temporal Ability
The Questionnaire of temporal ability is a new instrument to measure the ability to locate 10 daily activities in time.
Measured: baseline
Assessment of General Cognitive Functioning on the Mini Mental State Examination (MMSE)
The MMSE is a 30-point questionnaire that examines functions including registration (repeating named prompts), attention and calculation, recall, language, ability to follow simple commands and orientation. The score ranges from 0 to 30 (cut-off = 24).
Measured: baseline
Assessment of Verbal Comprehension on the Token Test
The Token test is a test of auditory language processing in which participants are asked to manipulate tokens of different shapes, sizes, and colors in response to increasingly complex instructions. One point is credited for a correct performance on the first presentation and 0.5 point if the performance is correct only on the second presentation. The score ranges from 0 to 36 (cut-off = 26,50).
Measured: baseline
Correlation between Time Estimation, Time Reproduction and Virtual Reality
Time Estimation, Time Reproduction and VR tasks will be correlated to investigate the relationship between computerized tasks and virtual reality tasks.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Feb 2019
- Primary completion1 Dec 2022
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Brain DamageStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bologna
- Responsible party
- Sponsor
- Investigators
- Francesca Frassinetti, PhD, Principal investigator, Istituti Clinici Scientifici Maugeri IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419818
- Sponsor's protocol ID
- ICS Maugeri CE 2194-Ob2B
- Status last verified
- Sep 2023
- First submitted
- 3 Jun 2020
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anelli F, Avanzi S, Arzy S, Mancuso M, Frassinetti F. Effects of spatial attention on mental time travel in patients with neglect. Cortex. 2018 Apr;101:192-205. doi: 10.1016/j.cortex.2018.01.012. Epub 2018 Feb 2.
PubMed 29482017Anelli F, Avanzi S, Damora A, Mancuso M, Frassinetti F. Mental time travel and functional daily life activities in neglect patients: Recovery effects of rehabilitation by prism adaptation. Cortex. 2019 Apr;113:141-155. doi: 10.1016/j.cortex.2018.12.003. Epub 2018 Dec 14.
PubMed 30660953De Renzi E, Faglioni P. Normative data and screening power of a shortened version of the Token Test. Cortex. 1978 Mar;14(1):41-9. doi: 10.1016/s0010-9452(78)80006-9.
PubMed 16295108Della Sala S, MacPherson SE, Phillips LH, Sacco L, Spinnler H. How many camels are there in Italy? Cognitive estimates standardised on the Italian population. Neurol Sci. 2003 Apr;24(1):10-5. doi: 10.1007/s100720300015.
PubMed 12754651Demeurisse G, Demol O, Robaye E. Motor evaluation in vascular hemiplegia. Eur Neurol. 1980;19(6):382-9. doi: 10.1159/000115178.
PubMed 7439211Espinosa-Fernandez L, Miro E, Cano M, Buela-Casal G. Age-related changes and gender differences in time estimation. Acta Psychol (Amst). 2003 Mar;112(3):221-32. doi: 10.1016/s0001-6918(02)00093-8.
PubMed 12595147Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
PubMed 1202204Frassinetti F, Magnani B, Oliveri M. Prismatic lenses shift time perception. Psychol Sci. 2009 Aug;20(8):949-54. doi: 10.1111/j.1467-9280.2009.02390.x. Epub 2009 Jun 22.
PubMed 19549081Patane I, Farne A, Frassinetti F. Prismatic Adaptation Induces Plastic Changes onto Spatial and Temporal Domains in Near and Far Space. Neural Plast. 2016;2016:3495075. doi: 10.1155/2016/3495075. Epub 2016 Feb 14.
PubMed 26981286Wiener M, Zhou W, Bader F, Joiner WM. Movement Improves the Quality of Temporal Perception and Decision-Making. eNeuro. 2019 Aug 20;6(4):ENEURO.0042-19.2019. doi: 10.1523/ENEURO.0042-19.2019. Print 2019 Jul/Aug.
PubMed 31395616Cantarella G, Vianello G, Vezzadini G, Frassinetti F, Ciaramelli E, Candini M. Time bisection and reproduction: Evidence for a slowdown of the internal clock in right brain damaged patients. Cortex. 2023 Oct;167:303-317. doi: 10.1016/j.cortex.2023.05.024. Epub 2023 Jul 25.
PubMed 37595392
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Neuropsychological Test Battery for the Assessment of Time Deficits in Brain-damaged Patients: a Correlation Study
- ClinicalTrials.gov ID
- NCT04419818
- Acronym / sponsor ID
- ICS Maugeri CE 2194-Ob2B
- Conditions
- Brain Damage, Health Behavior
- Keywords
- Time perception, Mental Time Travel, Virtual Reality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Collaborators
- University of Bologna
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 5 Jun 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.
Time processing involves different abilities - i.e. estimating the duration of an event and moving in past and future time - and it is a fundamental ability in everyday life. For these reasons the assessment and the rehabilitation of time deficits in brain damaged patients is extremely important.
The ability to estimate and reproduce time processing is usually evaluated using computerized tasks and it is influenced by aging: young participants overestimate and elderly participants underestimate time durations.
Virtual Reality is an ecological approach that has recently been used for the assessment of cognitive deficits. Here we use Virtual Reality to study the ability to estimate time duration of an action execution and perception in a simulated everyday activity.
Detailed description
Time processing involves different abilities - i.e. estimating the duration of an event and moving in past and future time - and it is a fundamental ability in everyday life. However, in neuropsychology, time processing is routinely neglected in the assessment of cognitive deficits in brain-damaged patients. The discrepancy between the importance of time processing and the lack of instruments for the diagnosis of time deficits in brain damaged patients can be mainly due to the fact that time difficulties fail to emerge in a hospital context where daily activities are routinely scheduled by careers. Thus, time deficits become critical only when patients return home and, for younger patients, when they go back to working activities. For these reasons the assessment and the rehabilitation of time deficits in brain damaged patients is extremely important.
Interestingly, recent evidence has begun to demonstrate that our perceptions and sensations are influenced by motor movements and actions. Further, there is also evidence suggesting that movement not only biases perceived time, but can enhance it, suggesting the motor system directly influences temporal perception.
The ability to estimate and reproduce time in actions is usually evaluated using computerized tasks and it is influenced by aging: young participants overestimate and elderly participants underestimate time durations.
Virtual Reality is an ecological approach that has recently been used for the assessment of cognitive deficits. Here we use Virtual Reality to study the ability to estimate time duration of an action execution and perception in a simulated everyday activity.
The primary aim of the project is to measure the impact of time deficits and its effects on everyday life: a neuropsychological battery assessing time processing (Time Estimation, Time Reproduction, Mental Time Travel) is tested using both computerized and virtual reality tasks.
Moreover, the project aims also to investigate i) the correlation between Time Reproduction in a computerized task and the ability to reproduce the duration of an executed action in Virtual Reality; ii) the correlation between Time Estimation in a computerized task and the ability to estimate the duration of an executed action in Virtual Reality.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Left brain damaged patients | – | Behavioral: Virtual RealityA group of 20 left brain damaged (LBD) patients will perform: * a computerized test battery to measure time abilities (Mental Time Travel, Time Estimation and Time Reproduction); * a neuropsychological screening (Mini Mental State Examination and Token Test) to assess inclusion/exclusion criteria; * questionnaires to evaluate the time needed to execute actions and the ability to locate daily activities in time. |
| Right brain damaged patients | – | Behavioral: Virtual RealityA group of 20 right brain damaged (RBD) patients will perform: * a computerized test battery to measure time abilities (Mental Time Travel, Time Estimation and Time Reproduction); * a neuropsychological screening (Mini Mental State Examination and Token Test) to assess inclusion/exclusion criteria; * questionnaires to evaluate the time needed to execute actions and the ability to locate daily activities in time. |
| Healthy controls | – | Behavioral: Virtual RealityA group of 40 (20 young and 20 elderly) healthy controls (HC) will perform: * a computerized test battery to measure time abilities (Mental Time Travel, Time Estimation and Time Reproduction); * a neuropsychological screening (Mini Mental State Examination) to assess inclusion/exclusion criteria; * questionnaires to evaluate the time needed to execute actions and the ability to locate daily activities in time. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected from primary care clinic and they will be compared with matched healthy controls. Healthy controls will be selected from a community sample who volunteer to participate in the research.
Key inclusion criteria (1 listed)
- patients with focal right and left brain-damage
Key exclusion criteria (4 listed)
- generalized cognitive impairment (score lower than 24 at the Mini Mental State Examination)
- psychiatric disorders
- additional neurological disorders
- abusive use of alcohol or illicit drugs
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 |
|---|---|---|
| Virtual RealityVirtual Reality task consists of a 3D computer-generated virtual environment that will be displayed on a desktop VR computer monitor. A joystick will provide the graphical interface for patients by allowing user-friendly exploration of virtual scenarios. Participants will be presented 16 actions, with dynamic simulations of real life situations. They will verbally estimate and reproduce the duration of each previously presented action. | Behavioural | Healthy controls, Left brain damaged patients, Right brain damaged patients |
Primary outcome
Assessment of Mental Time Travel Ability on the Mental Time Travel (MTT) Task
Time frame: baseline
In the MTT task participants are listened to auditory stimuli consisting of brief descriptions of personal and non-personal events. They are required to project themselves in the past (10 years ago), present or future (10 years from now) and to verbally determine whether each event has already happened (relative past event) or is yet to happen (relative future event) with respect to the specific self-location in time (past, present and future). Error rates and reaction times will be recorded and analyzed.
Assessment of Time Estimation Ability on the Time Estimation Task - long intervals
Time frame: baseline
The Time Estimation task consists of a red square that is displayed for different durations (3500, 5500, 7500, 9500, 11500 ms) on the computer screen. Participants are instructed to verbally judge whether the duration of each stimulus is "short" or "long" with respect to previously acquired pair of reference durations (3500 and 11500 ms). A psychophysical response function will be created for each participant by calculating the proportion of "long" responses: the Point of Subjective Equality (PSE) is the duration at which a participant is equally likely to classify the stimuli as short or long. Lower PSE reflects a relative shift towards overestimation of temporal midpoint. Conversely, higher PSE reflects a relative shift towards underestimation of temporal midpoint.
Assessment of Time Estimation Ability on the Time Estimation Task - short intervals
Time frame: baseline
The Time Estimation task consists of a red square that is displayed for different durations (1400, 1700, 2000, 2300, 2600 ms) on the computer screen. Participants are instructed to verbally judge whether the duration of each stimulus is "short" or "long" with respect to previously acquired pair of reference durations (1400 and 2600 ms). A psychophysical response function will be created for each participant by calculating the proportion of "long" responses: the Point of Subjective Equality (PSE) is the duration at which a participant is equally likely to classify the stimuli as short or long. Lower PSE reflects a relative shift towards overestimation of temporal midpoint. Conversely, higher PSE reflects a relative shift towards underestimation of temporal midpoint.
Assessment of Time Reproduction Ability on the Time Reproduction Task - long intervals
Time frame: baseline
In the Time Reproduction task a blue square is presented for a variable time interval (3500, 5500, 7500, 9500, 11500 ms) on the computer screen. Next, a red square appears on the screen and participants are instructed to reproduce the entire duration of the preceding blue square by pressing the space bar on the keyboard. The reproduced time intervals will be compared to the real ones: the difference will be positive when reproduced time will be longer (underestimation of time duration) and negative when reproduced time will be shorter (overestimation of time duration) than the real one.
Assessment of Time Reproduction Ability on the Time Reproduction Task - short intervals
Time frame: baseline
In the Time Reproduction task a blue square is presented for a variable time interval (1400, 1700, 2000, 2300, 2600 ms) on the computer screen. Next, a red square appears on the screen and participants are instructed to reproduce the entire duration of the preceding blue square by pressing the space bar on the keyboard. The reproduced time intervals will be compared to the real ones: the difference will be positive when reproduced time will be longer (underestimation of time duration) and negative when reproduced time will be shorter (overestimation of time duration) than the real one.
6 secondary outcomes
Assessment of Verbal Estimation Ability on the Time and Weight Estimation Test (STEP)
Time frame: baseline
Assessment of Verbal Estimation Ability on the Cognitive Estimation Task (CET)
Time frame: baseline
Assessment of Functional Abilities on the Questionnaire of Temporal Ability
Time frame: baseline
Assessment of General Cognitive Functioning on the Mini Mental State Examination (MMSE)
Time frame: baseline
Assessment of Verbal Comprehension on the Token Test
Time frame: baseline
Correlation between Time Estimation, Time Reproduction and Virtual Reality
Time frame: baseline
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 25 Sep 2023.
- Background: PubMed 29482017Anelli F, Avanzi S, Arzy S, Mancuso M, Frassinetti F. Effects of spatial attention on mental time travel in patients with neglect. Cortex. 2018 Apr;101:192-205. doi: 10.1016/j.cortex.2018.01.012. Epub 2018 Feb 2.
- Background: PubMed 30660953Anelli F, Avanzi S, Damora A, Mancuso M, Frassinetti F. Mental time travel and functional daily life activities in neglect patients: Recovery effects of rehabilitation by prism adaptation. Cortex. 2019 Apr;113:141-155. doi: 10.1016/j.cortex.2018.12.003. Epub 2018 Dec 14.
- Background: PubMed 16295108De Renzi E, Faglioni P. Normative data and screening power of a shortened version of the Token Test. Cortex. 1978 Mar;14(1):41-9. doi: 10.1016/s0010-9452(78)80006-9.
- Background: PubMed 12754651Della Sala S, MacPherson SE, Phillips LH, Sacco L, Spinnler H. How many camels are there in Italy? Cognitive estimates standardised on the Italian population. Neurol Sci. 2003 Apr;24(1):10-5. doi: 10.1007/s100720300015.
- Background: PubMed 7439211Demeurisse G, Demol O, Robaye E. Motor evaluation in vascular hemiplegia. Eur Neurol. 1980;19(6):382-9. doi: 10.1159/000115178.
- Background: PubMed 12595147Espinosa-Fernandez L, Miro E, Cano M, Buela-Casal G. Age-related changes and gender differences in time estimation. Acta Psychol (Amst). 2003 Mar;112(3):221-32. doi: 10.1016/s0001-6918(02)00093-8.
- Background: PubMed 1202204Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
- Background: PubMed 19549081Frassinetti F, Magnani B, Oliveri M. Prismatic lenses shift time perception. Psychol Sci. 2009 Aug;20(8):949-54. doi: 10.1111/j.1467-9280.2009.02390.x. Epub 2009 Jun 22.
- Background: PubMed 26981286Patane I, Farne A, Frassinetti F. Prismatic Adaptation Induces Plastic Changes onto Spatial and Temporal Domains in Near and Far Space. Neural Plast. 2016;2016:3495075. doi: 10.1155/2016/3495075. Epub 2016 Feb 14.
- Background: PubMed 31395616Wiener M, Zhou W, Bader F, Joiner WM. Movement Improves the Quality of Temporal Perception and Decision-Making. eNeuro. 2019 Aug 20;6(4):ENEURO.0042-19.2019. doi: 10.1523/ENEURO.0042-19.2019. Print 2019 Jul/Aug.
- Results publication: PubMed 37595392Cantarella G, Vianello G, Vezzadini G, Frassinetti F, Ciaramelli E, Candini M. Time bisection and reproduction: Evidence for a slowdown of the internal clock in right brain damaged patients. Cortex. 2023 Oct;167:303-317. doi: 10.1016/j.cortex.2023.05.024. Epub 2023 Jul 25.
- 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.
Francesca Frassinetti, PhD principal investigator
Istituti Clinici Scientifici Maugeri IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Damage and Health Behavior, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
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 1 inclusion and 4 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 25 Sep 2023. 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 Italy. 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?
Assessment of Mental Time Travel Ability on the Mental Time Travel (MTT) Task (time frame: baseline). 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?
On the ClinicalTrials.gov record for NCT04419818, which also lists 11 linked publications.
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 25 Sep 2023.