NCT04419818

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2023

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

3.8 years

First QC Date

June 3, 2020

Last Update Submit

September 21, 2023

Conditions

Keywords

Time perceptionMental Time TravelVirtual Reality

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (6)

  • Assessment of Verbal Estimation Ability on the Time and Weight Estimation Test (STEP)

    baseline

  • Assessment of Verbal Estimation Ability on the Cognitive Estimation Task (CET)

    baseline

  • Assessment of Functional Abilities on the Questionnaire of Temporal Ability

    baseline

  • Assessment of General Cognitive Functioning on the Mini Mental State Examination (MMSE)

    baseline

  • Assessment of Verbal Comprehension on the Token Test

    baseline

  • +1 more secondary outcomes

Study Arms (3)

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.

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.

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.

Behavioral: Virtual Reality

Interventions

Virtual RealityBEHAVIORAL

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.

Healthy controlsLeft brain damaged patientsRight brain damaged patients

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • patients with focal right and left brain-damage

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICS Maugeri IRCCS, U.O. di Rieducazione e Recupero funzionale di Castel Goffredo

Castel Goffredo, Mantova, 46042, Italy

Location

Related 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.

    PMID: 29482017BACKGROUND
  • 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.

    PMID: 30660953BACKGROUND
  • 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.

    PMID: 16295108BACKGROUND
  • 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.

    PMID: 12754651BACKGROUND
  • Demeurisse G, Demol O, Robaye E. Motor evaluation in vascular hemiplegia. Eur Neurol. 1980;19(6):382-9. doi: 10.1159/000115178.

    PMID: 7439211BACKGROUND
  • 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.

    PMID: 12595147BACKGROUND
  • 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.

    PMID: 1202204BACKGROUND
  • 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.

    PMID: 19549081BACKGROUND
  • 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.

    PMID: 26981286BACKGROUND
  • 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.

    PMID: 31395616BACKGROUND
  • 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 Oct;167:303-317. doi: 10.1016/j.cortex.2023.05.024. Epub 2023 Jul 25.

MeSH Terms

Conditions

Brain InjuriesHealth Behavior

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesBehavior

Study Officials

  • Francesca Frassinetti, PhD

    Istituti Clinici Scientifici Maugeri IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 5, 2020

Study Start

February 1, 2019

Primary Completion

December 1, 2022

Study Completion

January 13, 2023

Last Updated

September 25, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations