Health Behavior Clinical Trial
Official title:
A Neuropsychological Test Battery for the Assessment of Time Deficits in Brain-damaged Patients: a Correlation Study
Verified date | September 2023 |
Source | Istituti Clinici Scientifici Maugeri SpA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 96 |
Est. completion date | January 13, 2023 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 85 Years |
Eligibility | Inclusion Criteria: - patients with focal right and left brain-damage Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Italy | ICS Maugeri IRCCS, U.O. di Rieducazione e Recupero funzionale di Castel Goffredo | Castel Goffredo | Mantova |
Lead Sponsor | Collaborator |
---|---|
Istituti Clinici Scientifici Maugeri SpA | University of Bologna |
Italy,
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Cantarella 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 Jul 25;167:303-317. doi: 10.1016/j.cortex.2023.05.0 — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
baseline | |
Primary | 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. |
baseline | |
Primary | 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. |
baseline | |
Primary | 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. |
baseline | |
Primary | 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. |
baseline | |
Secondary | 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. | baseline | |
Secondary | 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. | baseline | |
Secondary | 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. | baseline | |
Secondary | 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). | baseline | |
Secondary | 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). | baseline | |
Secondary | 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. | baseline |
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