Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04419818
Other study ID # ICS Maugeri CE 2194-Ob2B
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2019
Est. completion date January 13, 2023

Study information

Verified date September 2023
Source Istituti Clinici Scientifici Maugeri SpA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Virtual Reality
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.

Locations

Country Name City State
Italy ICS Maugeri IRCCS, U.O. di Rieducazione e Recupero funzionale di Castel Goffredo Castel Goffredo Mantova

Sponsors (2)

Lead Sponsor Collaborator
Istituti Clinici Scientifici Maugeri SpA University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (11)

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. — View Citation

Anelli 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. — View Citation

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

De 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. — View Citation

Della 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. — View Citation

Demeurisse G, Demol O, Robaye E. Motor evaluation in vascular hemiplegia. Eur Neurol. 1980;19(6):382-9. doi: 10.1159/000115178. — View Citation

Espinosa-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. — View Citation

Folstein 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. — View Citation

Frassinetti 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. — View Citation

Patane 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. — View Citation

Wiener 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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT05009251 - Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake N/A
Recruiting NCT04356924 - Psychological Treatment to Support the Consequences of Cognitive Impairment N/A
Completed NCT05509049 - Precision Nudging Drives Wellness Visit Attendance at Scale N/A
Completed NCT03904992 - Intervention With a Progressive Web App for the Promotion of Healthy Habits in Preschoolers N/A
Completed NCT05509270 - Efficacy of Communication Modalities for Promoting Flu Shots N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Completed NCT03081520 - Affective Responses Following Aerobic Exercise With Different Intensities N/A
Completed NCT05012163 - Lottery Incentive Nudges to Increase Influenza Vaccinations N/A
Completed NCT03982095 - Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
Recruiting NCT06467058 - Convergent Validity of DABQ Questionnaire N/A
Completed NCT02777086 - Sustainable HIV Risk Reduction Strategies for Probationers N/A
Completed NCT02996864 - Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II N/A
Not yet recruiting NCT06071130 - Emotion, Aging, and Decision Making N/A
Active, not recruiting NCT04152824 - Readiness Supportive Leadership Training N/A
Active, not recruiting NCT05541653 - The IGNITE Study on Concentrated Investment in Black Neighborhoods N/A
Completed NCT03875768 - Nourish: A Digital Health Program to Promote the DASH Eating Plan Among Adults With High Blood Pressure N/A
Completed NCT04089020 - Walking to School Supports N/A
Completed NCT03646903 - Reducing Help-Seeking Stigma in Young Adults at Elevated Suicide Risk N/A
Completed NCT03548077 - POWERPLAY: Promoting Men's Health at Work N/A
Recruiting NCT05249465 - Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention N/A