NCT04424199

Brief Summary

Time is an important function that permeates our everyday activities but it has been so far significantly under-investigated in neurological patients. For instance, it is known that right brain damaged (RBD) patients with spatial attentional deficit (neglect) are impaired in both the ability to estimate the duration of an event (Time Estimation), showing a time underestimation, and the ability of mentally moving in past and future time (Mental Time Travelling), showing a deficit in processing future events when they are projected in the past. After a leftward shift of spatial attention induced by prismatic adaptation (PA), both the underestimation and the ability to travel in time ameliorate. However, less is known about these abilities in left brain damaged (LBD) patients. Aims of this study are to investigate: i) the performance (in terms of accuracy and reaction times) of LBD and RBD patients on Mental Time Travelling; ii) the correlation between Mental Time Travelling and Time Estimation abilities; iii) the efficacy of a single session of PA inducing a leftward (L-PA) and a rightward (R-PA) attentional shift on Mental Time Travelling and Time Estimation abilities. A group of control subjects will be involved for comparison among groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

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
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

3.9 years

First QC Date

June 3, 2020

Last Update Submit

August 10, 2023

Conditions

Brain Disease

Keywords

Time perceptionMental Time TravelPrismatic adaptationLeft and Right Brain Damaged Patients

Outcome Measures

Primary Outcomes (2)

  • Change in 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. The improvement will be defined as changes in the Inverse Efficiency (IE) ability: reaction times/accuracy.

    pre-PA and immediately post-PA

  • Change in Time Estimation Ability on the Time Estimation Task

    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. An increase of "long" response after treatment, as compared to baseline performance, induces a decreased PSE, reflecting a relative shift towards overestimation of temporal midpoint. Conversely, an increase of "short" responses after treatment, as compared to baseline performance, induces an increased PSE, reflecting a relative shift towards underestimation of temporal midpoint.

    pre-PA and immediately post-PA

Secondary Outcomes (11)

  • Assessment of Unilateral Spatial Neglect on the Behavioral Inattention Test (BIT)

    baseline

  • Assessment of Unilateral Spatial Neglect on the Bells Cancellation Test

    baseline

  • Assessment of Unilateral Spatial Neglect on the Apples Cancellation Test

    baseline

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

    baseline

  • Assessment of Verbal Comprehension on the Token Test

    baseline

  • +6 more secondary outcomes

Study Arms (6)

LBD patients R-PA

A group of 10 left brain damaged (LBD) patients will attend two sessions: 1. First session - before prismatic adaptation (pre-PA): they will perform a computerized test battery to measure time abilities (Mental Time Travel and Time Estimation) and a neuropsychological test battery to assess cognitive abilities. 2. Second session - after prismatic adaptation (post-PA): they will perform the Mental Time Travel and Time Estimation tasks immediately after a single session of pointing with prismatic goggles inducing rightward attentional shift (R-PA).

Behavioral: Rightward Attentional Shift (R-PA)

LBD patients L-PA

A group of 10 left brain damaged (LBD) patients will attend two sessions: 1. First session - before prismatic adaptation (pre-PA): they will perform a computerized test battery to measure time abilities (Mental Time Travel and Time Estimation) and a neuropsychological test battery to assess cognitive abilities. 2. Second session - after prismatic adaptation (post-PA): they will perform the Mental Time Travel and Time Estimation tasks immediately after a single session of pointing with prismatic goggles inducing leftward attentional shift (L-PA).

Behavioral: Leftward Attentional Shift (L-PA)

RBD patients R-PA

A group of 10 right brain damaged (RBD) patients will attend two sessions: 1. First session - before prismatic adaptation (pre-PA): they will perform a computerized test battery to measure time abilities (Mental Time Travel and Time Estimation) and a neuropsychological test battery to assess cognitive abilities. 2. Second session - after prismatic adaptation (post-PA): they will perform the Mental Time Travel and Time Estimation tasks immediately after a single session of pointing with prismatic goggles inducing rightward attentional shift (R-PA).

Behavioral: Rightward Attentional Shift (R-PA)

RBD patients L-PA

A group of 10 right brain damaged (RBD) patients will attend two sessions: 1. First session - before prismatic adaptation (pre-PA): they will perform a computerized test battery to measure time abilities (Mental Time Travel and Time Estimation) and a neuropsychological test battery to assess cognitive abilities. 2. Second session - after prismatic adaptation (post-PA): they will perform the Mental Time Travel and Time Estimation tasks immediately after a single session of pointing with prismatic goggles inducing leftward attentional shift (L-PA).

Behavioral: Leftward Attentional Shift (L-PA)

HC R-PA

A group of 10 healthy controls (HC) will attend two sessions: 1. First session - before prismatic adaptation (pre-PA): they will perform a computerized test battery to measure time abilities (Mental Time Travel and Time Estimation) and a neuropsychological screening (Mini Mental State Examination) to assess inclusion/exclusion criteria. 2. Second session - after prismatic adaptation (post-PA): they will perform the Mental Time Travel and Time Estimation tasks immediately after a single session of pointing with prismatic goggles inducing rightward attentional shift (R-PA).

Behavioral: Rightward Attentional Shift (R-PA)

HC L-PA

A group of 10 healthy controls (HC) will attend two sessions: 1. First session - before prismatic adaptation (pre-PA): they will perform a computerized test battery to measure time abilities (Mental Time Travel and Time Estimation) and a neuropsychological screening (Mini Mental State Examination) to assess inclusion/exclusion criteria. 2. Second session - after prismatic adaptation (post-PA): they will perform the Mental Time Travel and Time Estimation tasks immediately after a single session of pointing with prismatic goggles inducing leftward attentional shift (L-PA).

Behavioral: Leftward Attentional Shift (L-PA)

Interventions

Rightward Attentional Shift (R-PA)BEHAVIORAL

Patients will perform a session of 90 pointing movements toward a visual target presented on the right, the left or at the center of the visual field. This pointing task will be performed with prismatic googles inducing a rightward attentional shift.

HC R-PALBD patients R-PARBD patients R-PA
Leftward Attentional Shift (L-PA)BEHAVIORAL

Patients will perform a session of 90 pointing movements toward a visual target presented on the right, the left or at the center of the visual field. This pointing task will be performed with prismatic googles inducing a leftward attentional shift.

HC L-PALBD patients L-PARBD patients L-PA

Eligibility Criteria

Age45 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 or 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 (14)

  • 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

  • Appollonio I, Leone M, Isella V, Piamarta F, Consoli T, Villa ML, Forapani E, Russo A, Nichelli P. The Frontal Assessment Battery (FAB): normative values in an Italian population sample. Neurol Sci. 2005 Jun;26(2):108-16. doi: 10.1007/s10072-005-0443-4.

    PMID: 15995827BACKGROUND

  • Bertossi E, Aleo F, Braghittoni D, Ciaramelli E. Stuck in the here and now: Construction of fictitious and future experiences following ventromedial prefrontal damage. Neuropsychologia. 2016 Jan 29;81:107-116. doi: 10.1016/j.neuropsychologia.2015.12.015. Epub 2015 Dec 18.

    PMID: 26707714BACKGROUND

  • Bertossi E, Tesini C, Cappelli A, Ciaramelli E. Ventromedial prefrontal damage causes a pervasive impairment of episodic memory and future thinking. Neuropsychologia. 2016 Sep;90:12-24. doi: 10.1016/j.neuropsychologia.2016.01.034. Epub 2016 Jan 28.

    PMID: 26827916BACKGROUND

  • Carlesimo GA, Caltagirone C, Gainotti G. The Mental Deterioration Battery: normative data, diagnostic reliability and qualitative analyses of cognitive impairment. The Group for the Standardization of the Mental Deterioration Battery. Eur Neurol. 1996;36(6):378-84. doi: 10.1159/000117297.

    PMID: 8954307BACKGROUND

  • 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

  • De Renzi E, Motti F, Nichelli P. Imitating gestures. A quantitative approach to ideomotor apraxia. Arch Neurol. 1980 Jan;37(1):6-10. doi: 10.1001/archneur.1980.00500500036003.

    PMID: 7350907BACKGROUND

  • 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

  • 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

  • Mancuso M, Rosadoni S, Capitani D, Bickerton WL, Humphreys GW, De Tanti A, Zampolini M, Galardi G, Caputo M, De Pellegrin S, Angelini A, Bartalini B, Bartolo M, Carboncini MC, Gemignani P, Spaccavento S, Cantagallo A, Zoccolotti P, Antonucci G. Italian standardization of the Apples Cancellation Test. Neurol Sci. 2015 Jul;36(7):1233-40. doi: 10.1007/s10072-015-2088-2. Epub 2015 Jan 25.

    PMID: 25618236BACKGROUND

  • Oliveri M, Magnani B, Filipelli A, Avanzi S, Frassinetti F. Prismatic adaptation effects on spatial representation of time in neglect patients. Cortex. 2013 Jan;49(1):120-30. doi: 10.1016/j.cortex.2011.11.010. Epub 2011 Nov 27.

    PMID: 22200531BACKGROUND

  • 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

  • Wilson B, Cockburn J, Halligan P. Development of a behavioral test of visuospatial neglect. Arch Phys Med Rehabil. 1987 Feb;68(2):98-102.

    PMID: 3813864BACKGROUND

MeSH Terms

Conditions

Brain Diseases

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

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 9, 2020

Study Start

February 1, 2019

Primary Completion

December 31, 2022

Study Completion

January 13, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)