Brain DiseaseNCT04424199

Temporal Disorders in Left and Right Brain-Damaged Patients

An observational study of Brain Disease, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 45 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Brain Disease
What is being tested?: Rightward Attentional Shift (R-PA) and Leftward Attentional Shift (L-PA)
Type of treatment: Lifestyle or therapy programme
How many people: 74 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 45 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 or 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

Other trials in Italy

About this study

Official title: The Relationship Between Our Ability in Travelling in Time and in Estimating Time Duration and Their Interaction With Spatial Attention: a Neuropsychological Study.

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:

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.

Read the detailed description

Time processing involves different abilities - i.e. estimating the duration of an event (Time Estimation) and moving in past and future time (Mental Time Travelling) - 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. This is surprising since time is an important function that permeates our activities: it is involved in perceiving mismatches in lip reading (milliseconds), estimating how long it takes to be ready for work (minutes), and planning how long it will take a manuscript to be accepted (usually months). Thus, impairment in processing time has important consequences in daily life.

For instance, it is known that right brain damaged (RBD) patients with spatial attentional deficit (neglect) underestimate durations of milliseconds and show a deficit in processing future events when they are projected in the past.

Moreover, previous studies have demonstrated that a leftward shift of spatial attention induced by prismatic adaptation (PA) determines an amelioration of both, time underestimation and the deficit in mental travel in time.

The Mental Time Travelling, in particular, seems to involve different cognitive functions, among others, episodic memory and the ability to anticipate the future. Recent evidence suggests that these functions are mediated by neural circuits localized in the left hemisphere but no studies have investigated the ability of mentally moving in past and future time in left brain damaged (LBD) patients.

Aims of this study are to investigate:

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.

Conditions: Brain Disease
Being tested: Rightward Attentional Shift (R-PA), Leftward Attentional Shift (L-PA)
Keywords: Time perception, Mental Time Travel, Prismatic adaptation, Left and Right Brain Damaged Patients
Medical subject headings: Brain Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rightward Attentional Shift (R-PA)Behavioural
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.
Leftward Attentional Shift (L-PA)Behavioural
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.

Study groups in NCT04424199
Study group	Role	What they receive
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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: Behavioral: Leftward Attentional Shift (L-PA)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: pre-PA and immediately post-PA

Secondary outcomes (11)

Assessment of Unilateral Spatial Neglect on the Behavioral Inattention Test (BIT)
The BIT is composed of two scales, the Conventional scale and the Behavioral scale. Participants will be administered the Conventional scale, which includes 6 tasks: line crossing, letter cancellation, star cancellation, figure and shape copying, line bisection and representational drawing. The score ranges from 0 to 146 (cut-off = 129).
Measured: baseline
Assessment of Unilateral Spatial Neglect on the Bells Cancellation Test
The subject is required to cross out the bells that are scattered among several different shapes on a sheet of paper. Two indices of neglect will be calculated: total number of omissions (cut-off < 5) and number of left omissions (cut-off < 5), i.e. the difference between the number of targets crossed out on the right side and the number of targets crossed out on the left side (asymmetry score).
Measured: baseline
Assessment of Unilateral Spatial Neglect on the Apples Cancellation Test
This is a cancellation task in which outline drawings of 150 apples are shown pseudorandomly scattered over a sheet of A4 paper presented in a landscape orientation. All of the apples are presented in an upright position. One-third of the apples are full (targets) and two-thirds are open on either the left or the right side (distractors). Participants are asked to cross out all the full apples and to ignore the distractors. Three scores will be calculated: full apples barrage (cut-off = 45), full apples asymmetry (cut-off = 2), and incomplete apples asymmetry (cut-off = 1).
The full apples asymmetry (the difference between the number of targets selected on the right side and the number of targets selected on the left side) represents the score for egocentric neglect. The incomplete apples asymmetry (total left openings minus total right openings) represents the score for allocentric neglect.
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
Assessment of Frontal Functions on the Frontal Assessment Battery (FAB)
The FAB is a brief battery of six neuropsychological tasks designed to assess frontal lobe function at bedside. The six tasks explore: conceptualization and abstract reasoning, lexical verbal fluency and mental flexibility, motor programming and executive control of action, self-regulation and resistance to interference, inhibitory control, and environmental autonomy.
Each task scores from 0 (pathologic) to 3 (best performance), for a total maximum score of 18.
Measured: baseline
Assessment of Memory on the Rey's 15 Words Auditory Learning Test
The test is designed as a list-learning paradigm in which the participant hears a list of 15 nouns and is asked to recall as many words from the list as possible (five repetitions of free-recall). After a 15 min delay, the participant is asked to again recall the words from the list. It provides two scores: immediate (range 0-75) and delayed recall (range 0-15), i.e. the higher the score, the better the performance.
Measured: baseline
Assessment of Ideomotor Apraxia on the Movement Imitation Test
The ability to carry out movements on imitation is assessed with a 24-item test. Each movement is presented for a maximum of 3 times and scores from 0 (pathologic) to 3 (best performance). The total score ranges from 0 to 72 (cut-off = 62).
Measured: baseline
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 that required 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
Correlation between Time Processing Abilities
MTT and Time Estimation Task will be correlated to investigate the relationship between different time processing abilities.
Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201913 Jan 2023

First posted9 Jun 2020
Study start1 Feb 2019
Primary completion31 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 (14)Papers the sponsor has linked to this study.
Other trials for Brain DiseaseStudies of the same condition, open and under way.
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: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04424199
Sponsor's protocol ID: ICS Maugeri CE 2194-Ob1
Status last verified: Aug 2023
First submitted: 3 Jun 2020
Last updated: 14 Aug 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 29482017
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.
PubMed 30660953
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.
PubMed 15995827
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.
PubMed 26707714
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.
PubMed 26827916
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.
PubMed 8954307
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.
PubMed 16295108
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.
PubMed 7350907
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.
PubMed 12754651
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.
PubMed 1202204
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.
PubMed 25618236
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.
PubMed 22200531
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.
PubMed 26981286
Wilson B, Cockburn J, Halligan P. Development of a behavioral test of visuospatial neglect. Arch Phys Med Rehabil. 1987 Feb;68(2):98-102.
PubMed 3813864

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The sponsor has not listed a contact. The official record may have more details.

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Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Relationship Between Our Ability in Travelling in Time and in Estimating Time Duration and Their Interaction With Spatial Attention: a Neuropsychological Study.
ClinicalTrials.gov ID: NCT04424199
Acronym / sponsor ID: ICS Maugeri CE 2194-Ob1
Conditions: Brain Disease
Keywords: Time perception, Mental Time Travel, Prismatic adaptation, Left and Right Brain Damaged Patients
Study type: Observational
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
Collaborators: University of Bologna
Study start: 1 Feb 2019 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 13 Jan 2023 (actual)
First posted: 9 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 is an important function that permeates our everyday activities but it has been so far significantly under-investigated in neurological patients.

Aims of this study are to investigate:

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.

Detailed description

Aims of this study are to investigate:

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.

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 6

Arm	Type	Receives
LBD patients R-PA	–	Behavioral: Rightward Attentional Shift (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).
LBD patients L-PA	–	Behavioral: Leftward Attentional Shift (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).
RBD patients R-PA	–	Behavioral: Rightward Attentional Shift (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).
RBD patients L-PA	–	Behavioral: Leftward Attentional Shift (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).
HC R-PA	–	Behavioral: Rightward Attentional Shift (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).
HC L-PA	–	Behavioral: Leftward Attentional Shift (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).

Who may qualify

Ages: 45 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 or 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
Rightward Attentional Shift (R-PA)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.	Behavioural	HC R-PA, LBD patients R-PA, RBD patients R-PA
Leftward Attentional Shift (L-PA)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.	Behavioural	HC L-PA, LBD patients L-PA, RBD patients L-PA

Primary outcome

Change in Mental Time Travel Ability on the Mental Time Travel (MTT) Task
Time frame: pre-PA and immediately post-PA
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.
Change in Time Estimation Ability on the Time Estimation Task
Time frame: pre-PA and immediately post-PA
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.

11 secondary outcomes

Assessment of Unilateral Spatial Neglect on the Behavioral Inattention Test (BIT)
Time frame: baseline
Assessment of Unilateral Spatial Neglect on the Bells Cancellation Test
Time frame: baseline
Assessment of Unilateral Spatial Neglect on the Apples Cancellation Test
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
Assessment of Frontal Functions on the Frontal Assessment Battery (FAB)
Time frame: baseline
Assessment of Memory on the Rey's 15 Words Auditory Learning Test
Time frame: baseline
Assessment of Ideomotor Apraxia on the Movement Imitation Test
Time frame: baseline
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
Correlation between Time Processing Abilities
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 14 Aug 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 15995827Appollonio 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.
Background: PubMed 26707714Bertossi 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.
Background: PubMed 26827916Bertossi 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.
Background: PubMed 8954307Carlesimo 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.
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 7350907De 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.
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 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 25618236Mancuso 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.
Background: PubMed 22200531Oliveri 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.
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 Disease, 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 14 Aug 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?

Change in Mental Time Travel Ability on the Mental Time Travel (MTT) Task (time frame: pre-PA and immediately post-PA). The study lists 2 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 NCT04424199, which also lists 14 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 14 Aug 2023.