Rehabilitation Treatment of Time Deficits in Brain-damaged Patients

NCT04373837 | Completed

• 1 other identifier: ICS Maugeri CE 2194-Ob2A
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Damage

Keywords

Right Brain Damaged Patients; Time perception; Mental Time Travel; Prismatic adaptation; Virtual Reality

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

  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)

  baseline

• Assessment of Verbal Comprehension on the Token Test

  baseline

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

  baseline

• Assessment of Frontal Functions on the Wisconsin Card Sorting Test (WCST)

  baseline

• Assessment of Memory on the Rey's 15 Words Auditory Learning Test

  baseline

Study Arms (2)

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).

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).

Behavioral: Prismatic googles inducing prismatic adaptation (PA) associated to Virtual Reality (VR); Other: Neutral googles inducing no-adaptation (NA) associated to Virtual Reality (VR)

Interventions

Prismatic googles inducing prismatic adaptation (PA) associated to Virtual Reality (VR) BEHAVIORAL

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.

Group 1: Without pre - With post; Group 2: With pre - Without post

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.

Group 1: Without pre - With post; Group 2: With pre - Without post

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with focal right 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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• University of Bologna: collaborator

Study Sites (1)

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

Castel Goffredo, Mantova, 46042, Italy

Location

Related Publications (19)

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MeSH Terms

Conditions

Brain Injuries

Interventions

Sodium

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Francesca Frassinetti, PhD

  Istituti Clinici Scientifici Maugeri IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 5, 2020
• Study Start: February 1, 2018
• Primary Completion: March 20, 2018
• Study Completion: January 13, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)