Prismatic Adaptation in Cognitive Rehabilitation
ConditionTraumatic Brain Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituti Clinici Scientifici Maugeri SpA
About this trial
The study aims to evaluate the effects of prismatic adaptation and then of a novel rehabilitation protocol that combines PA and Serious Games on cognitive and behavioural deficits in patients with traumatic brain injury , compared to a rehabilitation training without prismatic adaptation.
Moreover, this study aims to assess the impact of this rehabilitation protocol on functional cognitive outcomes.
Hypothesis Hypothesis 1 (H1): It is postulated that the utilization of Prismatic Adaptation Treatment (PAT) has a positive impact on the enhancement of cognitive outcome among patients suffering from TBI
Hypothesis 2 (H2): It is hypothesized that there will be discernible alterations in resting-state Electroencephalography (EEG) patterns between the initial assessment point (T0) and the subsequent measurement during the course of treatment (T1) in individuals diagnosed with TBI
Assessment times of outcome measures will be conducted before the experimental treatment (T0) and after the 10 rehabilitation sessions (T1).
Patients will be randomized into two groups:
1. Experimental group: Patients receiving treatment with prismatic lenses and serious games lasting 10 days over a span of 2 weeks, for 40 minutes each session. 2. Control group: patients receiving the same serious games for 10 days over a span of 2 weeks, withouth prismatic adaptation session.
Both groups will receive also the standard cognitive rehabilitation for the detected deficits, using paper and pen materials.
Each rehabiliation session will last aproximately 1 hour for 5 days a week for 2 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years
Traumatic brain injury (TBI)
Rancho Level of Cognitive Functioning (LCF) for TBI patients > 4
Admission within 90 days from the onset
Disqualifiers
Unilateral Spatial Neglect
Aphasia
Severe vigilance deficits
Severe verbal comprehension deficits
Trial design
Design model
Parallel
Treatments tested in this trial
PRISMATIC ADAPTATION
DeviceThe experimental treatment includes a session of prismatic adaptation, in which patients, wearing priasmatic lenses, performs pointing exercises using an 11'' tablet. The visual target is represented by a black squares randomly presented in one of three spatial positions of the tablet's screen (in the centre of the screen or at 21° to the right or to the left space). Taking into account the type of lesion resulting from traumatic brain injury, the prismatic deviation induced by the lenses will be changed alternately from right to left. Then patients will wear rightward prism lenses for 5 days and leftward prism lenses for other 5 days. The prismatic deviation will be randomized. Following these prismatic adaptation, lasting 10 minutes, cognitive training with serious games will be performed, for the remaining 30 minutes.
Serious games
Devicepatients receiving the same serious games for 10 days over a span of 2 weeks, withouth prismatic adaptation session.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Prismatic adaptation groupExperimental treatment 2 interventions
Group B: Control groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Neuropsychological primary outcome measure
\- Montreal Cognitive Assessment (MoCA) (0-30). High score means a better outcome.
Time frame
From the enrollment to the end of treatment at 2 weeks.Secondary outcomes
1
Neurophysiological secondary outcome
The investigator will collect power spectra of frequency bands from continuous EEG resting state for 10 minutes (close+open eyes), before and after the treatment. EEGs were recorded with Ag/AgCl electrodes attached according to the 10-20 system. EEG data will be acquired, using a Galileo Mizar Plus medical device including 19 electrode channels (Fp1, Fp2,F7, F3, Fz, F4, F8, C3, Cz, C4, T7, T8, P7, P3, Pz, P4, P8, O1, O2), also during the last rehabilitation session. For obtaining the neurophysiological primary outcome measures, the invstigators will compute the power spectra of frequency bands from continuous EEG to assess the residual neuroplastic processes existing in patients, and the investigators will then evaluate the putative modulation of these processes by the combined intervention of prisms and serious games compared with traditional rehabilitation training.
Time frame
From the enrollment to the end of treatment at 2 weeks.2
Neuropsychiatric outcome
\- Neuropsychiatric Inventory (0-144): assesses 12 behavioral domains: delusions, hallucinations,agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, aberrant motor activity, night-time behavioral disturbances and appetite/eating disorders. The caregiver must rate the severity of the neuropsychiatric disturbances on a scale from 1 to 3, and the frequency from 1 to 4. High score means a worse outcome
Time frame
From the enrollment to the end of treatment at 2 weeks.3
Neuropsychological outcome measure
\- Stroop Test: this measures the ability to control and inhibit the automatic response. We used a short version of this test, with three tasks: (1) Word reading: the 30 stimuli are the written names of three colors (green, blue, and red). The subject must read the word as quickly as possible. (2) Color naming: 30 colored (green, blue, and red) circles are presented in a randomized order. The subject is asked to name the color of the circle. (3) Color naming of coloured words: 30 words (green, blue, and red) written in conflicting colors are presented. The subject has to name the character color of the word and not read the word itself aloud. High score both time and errors (0-30) means a worse outcome.
Time frame
From the enrollment to the end of treatment at 2 weeks.4
Neuropsychological outcome measure
Trail Making Test (TMT): this test explores visual-conceptual and visual-motor tracking and is divided into two parts, A and B. In part A the subject must first draw lines to consecutively connect the numbers from 1 to 25; in part B the subject must alternately connect the numbers from 1 to 13 and the letters from A to N. Scoring is based only on time, i.e., the number of seconds used to complete the test. High score means a worse outcome
Time frame
From the enrollment to the end of treatment at 2 weeks.Other outcomes
1
Functional cognitive secondary outcome
For the assessment of functional outcome, the following scales will be used: \- Functional Assessment Measure (FAM) cognitive subscale (14-98), composed of 14 items evaluating comprehension, expression, reading, writing, speech intelligibility, social interaction, emotional status, adjustment to limitation, employability, problem solving, memory, orientation, attention span and safety judgment. High score means a better outcome.
Time frame
From the enrollment to the end of treatment at 2 weeks.2
Functional secondary outcome
The Modified version of Barthel Index (BI) (0-100): composed of 10 variables, describing activities of daily living and mobility. The maximum total score is 100 points depending on the autonomy of the patients in performing the sub-tasks of the scale. High score means a better outcome
Time frame
From the enrollment to the end of treatment at 2 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov