Brain DamageNCT04373837

Rehabilitation Treatment of Time Deficits in Brain-damaged Patients

A study testing Prismatic googles inducing prismatic adaptation (PA) associated to Virtual Reality (VR) and Neutral googles inducing no-adaptation (NA) associated to Virtual Reality (VR) in people with Brain Damage, 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.

Official record

Search all trials

Trial summary

The efficacy of an innovative rehabilitation treatment for deficit in time processing is tested in right brain damaged patients. Patients with a focal lesion following a stroke and without general cognitive impairment will be submitted to computerized tests assessing the ability to estimate time duration (intervals… Read more about this study

Who is it for?: Ages 45 to 85 years
Conditions the study is for: Brain Damage
What is being tested?: Prismatic googles inducing prismatic adaptation (PA) associated to Virtual Reality (VR) and Neutral googles inducing no-adaptation (NA) associated to Virtual Reality (VR)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteItaly
Study dates: 1 Feb 2018to 13 Jan 2023
Phase: Interventional
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
No healthy volunteers
Adult, Older adult

Who may be able to join

patients with focal right 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: An Innovative Rehabilitation Treatment of Time Deficits in Brain-damaged Patients Combining Prism Adaptation and Virtual Reality

The efficacy of an innovative rehabilitation treatment for deficit in time processing is tested in right brain damaged patients.

Patients with a focal lesion following a stroke and without general cognitive impairment will be submitted to computerized tests assessing the ability to estimate time duration (intervals around 7500 ms) and to mental travel in time. Moreover, the impact of the deficit in time processing in everyday life will be evaluated by using ad hoc questionnaires.

Patients will perform tasks before and after two weeks of a new rehabilitation treatment, combining a training for one week with prismatic googles inducing prismatic adaptation (PA) plus Virtual Reality (VR) and a training for one week with neutral googles inducing no-adaptation (NA) plus Virtual Reality. Participants will be randomized into two groups. Each group will be submitted to both treatments in a different order, accordingly with a crossover design.

A greater amelioration in time processing after PA+VR than NA+VR training should be found. Moreover, an improvement in everyday life activities is expected accordingly with the amelioration in time processing.

Read the detailed 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. This is surprising since time is an important function that permeates our activities: we perceive mismatches in lip reading (milliseconds), we estimate how long it takes to be ready for work (minutes), and we plan 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) are impaired in estimate the duration of a time interval as well as in the ability of mentally moving in time (Mental Time Travelling).

Previous studies have demonstrated an improvement of time estimation and mental time travel after a leftward shift of spatial attention induced by a single session of prismatic adaptation (PA). Moreover, a recent study investigated the long-term duration of the benefits induced by 10 daily sessions of PA treatment on mental time travel and functional abilities in neglect patients. Results suggest that the PA treatment induces a long-lasting and stable ameliorations of mental time travel and functional competences.

To generalize the effects of PA treatment to everyday life, here we propose to combine PA with a virtual reality training (VR). VR has recently been used as an effective tool both for the assessment and rehabilitation of cognitive deficits, because it allows post-stroke patients to interact with ecological environments similar to the real ones, but in a safe and controlled condition.

Aim of this study is to set up a rehabilitation procedure for temporal deficits, combining a well-established PA procedure with an innovative, more engaging and ecological VR approach.

Conditions: Brain Damage
Being tested: Prismatic googles inducing prismatic adaptation (PA) associated to Virtual Reality (VR), Neutral googles inducing no-adaptation (NA) associated to Virtual Reality (VR)
Keywords: Right Brain Damaged Patients, Time perception, Mental Time Travel, Prismatic adaptation, Virtual Reality
Medical subject headings: Brain Injuries

What participants receive

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

Prismatic googles inducing prismatic adaptation (PA) associated to Virtual Reality (VR)Behavioural
The experimental condition consists of PA procedure associated to VR task: the pointing task will be followed by 5 sessions of VR task.
Pointing task. Patients will perform a session of 90 pointing movements toward a visual target presented in a variety of positions 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 shift of the visual field (experimental condition). After lenses removal, a leftward shift of spatial attention will be produced.
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. Patients 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.
Neutral googles inducing no-adaptation (NA) associated to Virtual Reality (VR)Other
The sham condition of this study consists of NA procedure associated to VR task: the pointing task will be followed by 5 sessions of VR task.
Pointing task. Patients will perform a session of 90 pointing movements toward a visual target presented in a variety of positions on the right, the left or at the center of the visual field. This pointing task will be performed with neutral goggles (control condition), which should not induce a shift of the visual field and of spatial attention.
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. Patients 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.

Study groups in NCT04373837
Study group	Role	What they receive
Group 1: Without pre - With post	Experimental	Patients will perform two weeks treatment (10 sessions in total). First week: 5 days/week for 1 week, a daily session of pointing with neutral goggles inducing no-adaptation (NA) + Virtual Reality (VR) task (5 sessions). Second week: 5 days/week for 1 week, a daily session of pointing with prismatic goggles inducing prismatic adaptation (PA) + VR task (5 sessions). Receives: Behavioral: Prismatic googles inducing prismatic adaptation (PA) associated to Virtual Reality (VR); Other: Neutral googles inducing no-adaptation (NA) associated to Virtual Reality (VR)
Group 2: With pre - Without post	Experimental	Patients will perform two weeks treatment (10 sessions in total). First week: 5 days/week for 1 week, a daily session of pointing with prismatic goggles inducing prismatic (PA) + Virtual Reality (VR) task (5 sessions). Second week: 5 days/week for 1 week, a daily session of pointing with neutral goggles inducing no-adaptation (NA) + VR task (5 sessions). Receives: Behavioral: Prismatic googles inducing prismatic adaptation (PA) associated to Virtual Reality (VR); Other: Neutral googles inducing no-adaptation (NA) associated to Virtual Reality (VR)

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: baseline, after one week treatment (T1), after two weeks treatment (T2), one week after the end of treatment (follow-up)
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 (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. 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: baseline, after one week treatment (T1), after two weeks treatment (T2), one week after the end of treatment (follow-up)
Change in Time Reproduction Ability on the Time Reproduction Task
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.
For each subject, the reproduced time intervals before PA will be subtracted from the reproduced time intervals after PA. Thus, this difference will be positive when reproduced time will be longer after than before treatment (underestimation of time duration) and negative when reproduced time will be shorter after than before treatment (overestimation of time duration).
Measured: baseline, after one week treatment (T1), after two weeks treatment (T2), one week after the end of treatment (follow-up)

Secondary outcomes (15)

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 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 Frontal Functions on the Wisconsin Card Sorting Test (WCST)
In the WCST, people have to classify cards according to different criteria. There are four different ways to classify each card, and the only feedback is whether the classification is correct or not. The classification rule changes every 10 cards. Three scores will be calculated: global score, perseveration errors and non-perseveration errors. The global score is computed by subtracting from the total number of administered trials the number of categories completed multiplied by ten = [n° of trials - (n° of achieved categories x 10)].
The score ranges from 128 to 0, i.e. the lower the score, the better the performance.
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
Change in 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, after two weeks treatment (T2), one week after the end of treatment (follow-up)
Change in 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, after two weeks treatment (T2), one week after the end of treatment (follow-up)
Change in 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, after two weeks treatment (T2)
Change in 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, after two weeks treatment (T2)
Change in 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, after two weeks treatment (T2)
Change in Functional Abilities on the Questionnaire of Temporal Ability
The Questionnaire of temporal ability is a new instrument to measure the ability to locate daily activities in time.
Measured: baseline, after two weeks treatment (T2), one week after the end of treatment (follow-up)
Change in Functional Abilities on the Motricity Index
The Motricity Index is a standardized mobility scale, designed to measure the motor impairment of the trunk and the right and left upper and low limbs. Each component part of the index expresses the strength of the part of the body that is evaluated. The score ranges from 0 (low motor functions) to 100 (high motor functions).
Measured: baseline, after two weeks treatment (T2)
Change in Functional Abilities on the Activities of Daily Living (ADL)
Eleven ADL areas, such as walking, dressing, cleaning, and feeding, are assessed to measure the degree of independence in activities of daily living. Each activity is evaluated through a 5-points questionnaire (1 = completely independent, 5 = completely dependent), with a total score ranging from 11 (high independence in ADL) to 55 (high dependence in ADL).
Measured: baseline, after two weeks treatment (T2), one week after the end of treatment (follow-up)
Change in Functional Abilities on the Functional Independent Measure (FIM)
The FIM is an 18-item, 7-level scale developed to uniformly assess severity of patient disability and medical rehabilitation functional outcome. Scores range from 18 (lowest) to 126 (highest) indicating level of function.
Measured: baseline, after two weeks treatment (T2)
Change in Spatial Working Memory on the Spatial Working Memory Test
Participants are presented with a paper sheet composed of 24 identical Os and 24 different drawings of common objects and they are instructed to cancel all Os, marking each once only. The score is the number of re-cancellations, that will be scored for any additional cross (an extra single line is scored as 0.5 re-cancellation).
Measured: baseline, after two weeks treatment (T2)

Timeline

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

1 Feb 201813 Jan 2023

First posted5 May 2020
Study start1 Feb 2018
Primary completion20 Mar 2018
Study completion13 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Brain DamageStudies of the same condition, open and under way.
More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04373837
Sponsor's protocol ID: ICS Maugeri CE 2194-Ob2A
Status last verified: Sep 2023
First submitted: 30 Apr 2020
Last updated: 29 Sep 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
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
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
Demeurisse G, Demol O, Robaye E. Motor evaluation in vascular hemiplegia. Eur Neurol. 1980;19(6):382-9. doi: 10.1159/000115178.
PubMed 7439211
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
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.
PubMed 19549081
GRANT DA, BERG EA. A behavioral analysis of degree of reinforcement and ease of shifting to new responses in a Weigl-type card-sorting problem. J Exp Psychol. 1948 Aug;38(4):404-11. doi: 10.1037/h0059831. No abstract available.
PubMed 18874598
KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.
PubMed 14044222
Laiacona M, Inzaghi MG, De Tanti A, Capitani E. Wisconsin card sorting test: a new global score, with Italian norms, and its relationship with the Weigl sorting test. Neurol Sci. 2000 Oct;21(5):279-91. doi: 10.1007/s100720070065.
PubMed 11286040
Linacre JM, Heinemann AW, Wright BD, Granger CV, Hamilton BB. The structure and stability of the Functional Independence Measure. Arch Phys Med Rehabil. 1994 Feb;75(2):127-32.
PubMed 8311667
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

Want to know more?

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

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy

All Brain Damage trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Innovative Rehabilitation Treatment of Time Deficits in Brain-damaged Patients Combining Prism Adaptation and Virtual Reality
ClinicalTrials.gov ID: NCT04373837
Acronym / sponsor ID: ICS Maugeri CE 2194-Ob2A
Conditions: Brain Damage
Keywords: Right Brain Damaged Patients, Time perception, Mental Time Travel, Prismatic adaptation, Virtual Reality
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
Collaborators: University of Bologna
Study start: 1 Feb 2018 (actual)
Primary completion: 20 Mar 2018 (actual)
Study completion: 13 Jan 2023 (actual)
First posted: 5 May 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.

The efficacy of an innovative rehabilitation treatment for deficit in time processing is tested in right brain damaged patients.

Detailed description

Aim of this study is to set up a rehabilitation procedure for temporal deficits, combining a well-established PA procedure with an innovative, more engaging and ecological VR approach.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1: Without pre - With post	Experimental	Behavioral: Prismatic googles inducing prismatic adaptation (PA) associated to Virtual Reality (VR), Other: Neutral googles inducing no-adaptation (NA) associated to Virtual Reality (VR)Patients will perform two weeks treatment (10 sessions in total). First week: 5 days/week for 1 week, a daily session of pointing with neutral goggles inducing no-adaptation (NA) + Virtual Reality (VR) task (5 sessions). Second week: 5 days/week for 1 week, a daily session of pointing with prismatic goggles inducing prismatic adaptation (PA) + VR task (5 sessions).
Group 2: With pre - Without post	Experimental	Behavioral: Prismatic googles inducing prismatic adaptation (PA) associated to Virtual Reality (VR), Other: Neutral googles inducing no-adaptation (NA) associated to Virtual Reality (VR)Patients will perform two weeks treatment (10 sessions in total). First week: 5 days/week for 1 week, a daily session of pointing with prismatic goggles inducing prismatic (PA) + Virtual Reality (VR) task (5 sessions). Second week: 5 days/week for 1 week, a daily session of pointing with neutral goggles inducing no-adaptation (NA) + VR task (5 sessions).

Who may qualify

Ages: 45 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

patients with focal right 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
Prismatic googles inducing prismatic adaptation (PA) associated to Virtual Reality (VR)The experimental condition consists of PA procedure associated to VR task: the pointing task will be followed by 5 sessions of VR task. Pointing task. Patients will perform a session of 90 pointing movements toward a visual target presented in a variety of positions 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 shift of the visual field (experimental condition). After lenses removal, a leftward shift of spatial attention will be produced. 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. Patients 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.	Behavioural	Group 1: Without pre - With post, Group 2: With pre - Without post
Neutral googles inducing no-adaptation (NA) associated to Virtual Reality (VR)The sham condition of this study consists of NA procedure associated to VR task: the pointing task will be followed by 5 sessions of VR task. Pointing task. Patients will perform a session of 90 pointing movements toward a visual target presented in a variety of positions on the right, the left or at the center of the visual field. This pointing task will be performed with neutral goggles (control condition), which should not induce a shift of the visual field and of spatial attention. 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. Patients 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.	Other	Group 1: Without pre - With post, Group 2: With pre - Without post

Primary outcome

Change in Mental Time Travel Ability on the Mental Time Travel (MTT) Task
Time frame: baseline, after one week treatment (T1), after two weeks treatment (T2), one week after the end of treatment (follow-up)
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: baseline, after one week treatment (T1), after two weeks treatment (T2), one week after the end of treatment (follow-up)
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. 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.
Change in Time Reproduction Ability on the Time Reproduction Task
Time frame: baseline, after one week treatment (T1), after two weeks treatment (T2), one week after the end of treatment (follow-up)
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. For each subject, the reproduced time intervals before PA will be subtracted from the reproduced time intervals after PA. Thus, this difference will be positive when reproduced time will be longer after than before treatment (underestimation of time duration) and negative when reproduced time will be shorter after than before treatment (overestimation of time duration).

15 secondary outcomes

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 Unilateral Spatial Neglect on the Behavioral Inattention Test (BIT)
Time frame: baseline
Assessment of Frontal Functions on the Wisconsin Card Sorting Test (WCST)
Time frame: baseline
Assessment of Memory on the Rey's 15 Words Auditory Learning Test
Time frame: baseline
Change in Unilateral Spatial Neglect on the Bells Cancellation Test
Time frame: baseline, after two weeks treatment (T2), one week after the end of treatment (follow-up)
Change in Unilateral Spatial Neglect on the Apples Cancellation Test
Time frame: baseline, after two weeks treatment (T2), one week after the end of treatment (follow-up)
Change in Frontal Functions on the Frontal Assessment Battery (FAB)
Time frame: baseline, after two weeks treatment (T2)
Change in Verbal Estimation Ability on the Time and Weight Estimation Test (STEP)
Time frame: baseline, after two weeks treatment (T2)
Change in Verbal Estimation Ability on the Cognitive Estimation Task (CET)
Time frame: baseline, after two weeks treatment (T2)
Change in Functional Abilities on the Questionnaire of Temporal Ability
Time frame: baseline, after two weeks treatment (T2), one week after the end of treatment (follow-up)
Change in Functional Abilities on the Motricity Index
Time frame: baseline, after two weeks treatment (T2)
Change in Functional Abilities on the Activities of Daily Living (ADL)
Time frame: baseline, after two weeks treatment (T2), one week after the end of treatment (follow-up)
Change in Functional Abilities on the Functional Independent Measure (FIM)
Time frame: baseline, after two weeks treatment (T2)
Change in Spatial Working Memory on the Spatial Working Memory Test
Time frame: baseline, after two weeks treatment (T2)

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 29 Sep 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 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 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 7439211Demeurisse G, Demol O, Robaye E. Motor evaluation in vascular hemiplegia. Eur Neurol. 1980;19(6):382-9. doi: 10.1159/000115178.
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 19549081Frassinetti 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.
Background: PubMed 18874598GRANT DA, BERG EA. A behavioral analysis of degree of reinforcement and ease of shifting to new responses in a Weigl-type card-sorting problem. J Exp Psychol. 1948 Aug;38(4):404-11. doi: 10.1037/h0059831. No abstract available.
Background: PubMed 14044222KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.
Background: PubMed 11286040Laiacona M, Inzaghi MG, De Tanti A, Capitani E. Wisconsin card sorting test: a new global score, with Italian norms, and its relationship with the Weigl sorting test. Neurol Sci. 2000 Oct;21(5):279-91. doi: 10.1007/s100720070065.
Individual participant dataSharing planned: No

Related trials for Brain Damage

Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy

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?

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 29 Sep 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: baseline, after one week treatment (T1), after two weeks treatment (T2), one week after the end of treatment (follow-up)). The study lists 3 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 NCT04373837, which also lists 19 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 29 Sep 2023.