Clinical trial NCT04373837: Rehabilitation Treatment of Time Deficits in Brain-damaged Patients
Official title: An Innovative Rehabilitation Treatment of Time Deficits in Brain-damaged Patients Combining Prism Adaptation and Virtual Reality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Damage
Keywords: Right Brain Damaged Patients
Time perception
Mental Time Travel
Prismatic adaptation
Virtual Reality
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
Collaborators: name: University of Bologna
First posted: 2020-05-05
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* patients with focal right brain-damage

Exclusion Criteria:

* generalized cognitive impairment (score lower than 24 at the Mini Mental State Examination)
* psychiatric disorders
* additional neurological disorders
* abusive use of alcohol or illicit drugs

Primary outcomes:
measure: Change in Mental Time Travel Ability on the Mental Time Travel (MTT) Task
timeFrame: baseline, after one week treatment (T1), after two weeks treatment (T2), one week after the end of treatment (follow-up)
measure: Change in Time Estimation Ability on the Time Estimation Task
timeFrame: baseline, after one week treatment (T1), after two weeks treatment (T2), one week after the end of treatment (follow-up)
measure: Change in Time Reproduction Ability on the Time Reproduction Task
timeFrame: baseline, after one week treatment (T1), after two weeks treatment (T2), one week after the end of treatment (follow-up)
Secondary outcomes:
measure: Assessment of General Cognitive Functioning on the Mini Mental State Examination (MMSE)
timeFrame: baseline
measure: Assessment of Verbal Comprehension on the Token Test
timeFrame: baseline
measure: Assessment of Unilateral Spatial Neglect on the Behavioral Inattention Test (BIT)
timeFrame: baseline
measure: Assessment of Frontal Functions on the Wisconsin Card Sorting Test (WCST)
timeFrame: baseline
measure: Assessment of Memory on the Rey's 15 Words Auditory Learning Test
timeFrame: baseline
measure: Change in Unilateral Spatial Neglect on the Bells Cancellation Test
timeFrame: baseline, after two weeks treatment (T2), one week after the end of treatment (follow-up)
measure: Change in Unilateral Spatial Neglect on the Apples Cancellation Test
timeFrame: baseline, after two weeks treatment (T2), one week after the end of treatment (follow-up)
measure: Change in Frontal Functions on the Frontal Assessment Battery (FAB)
timeFrame: baseline, after two weeks treatment (T2)
measure: Change in Verbal Estimation Ability on the Time and Weight Estimation Test (STEP)
timeFrame: baseline, after two weeks treatment (T2)
measure: Change in Verbal Estimation Ability on the Cognitive Estimation Task (CET)
timeFrame: baseline, after two weeks treatment (T2)
measure: Change in Functional Abilities on the Questionnaire of Temporal Ability
timeFrame: baseline, after two weeks treatment (T2), one week after the end of treatment (follow-up)
measure: Change in Functional Abilities on the Motricity Index
timeFrame: baseline, after two weeks treatment (T2)
measure: Change in Functional Abilities on the Activities of Daily Living (ADL)
timeFrame: baseline, after two weeks treatment (T2), one week after the end of treatment (follow-up)
measure: Change in Functional Abilities on the Functional Independent Measure (FIM)
timeFrame: baseline, after two weeks treatment (T2)
measure: Change in Spatial Working Memory on the Spatial Working Memory Test
timeFrame: baseline, after two weeks treatment (T2)
Other outcomes:
Locations:
city: Castel Goffredo
country: Italy
facility: ICS Maugeri IRCCS, U.O. di Rieducazione e Recupero funzionale di Castel Goffredo
state: Mantova
Study officials:
affiliation: Istituti Clinici Scientifici Maugeri IRCCS
name: Francesca Frassinetti, PhD
role: PRINCIPAL_INVESTIGATOR
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