Prismatic Adaptation in Cognitive Rehabilitation
NCT06920784, Not applicable, Recruiting, Istituti Clinici Scientifici Maugeri SpA
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Prismatic Adaptation in Cognitive Rehabilitation | ClinicalTrials.gov |
| NCT number | NCT06920784 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Istituti Clinici Scientifici Maugeri SpA | ClinicalTrials.gov |
| Conditions | Traumatic Brain Injury | ClinicalTrials.gov |
| Interventions | PRISMATIC ADAPTATION, Serious games | ClinicalTrials.gov |
| First posted | 2025-04-10 | ClinicalTrials.gov |
| Last updated | 2026-03-25 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Neuropsychological primary outcome measure | From the enrollment to the end of treatment at 2 weeks. | \- Montreal Cognitive Assessment (MoCA) (0-30). High score means a better outcome. | ClinicalTrials.gov |
| Secondary | Neurophysiological secondary outcome | From the enrollment to the end of treatment at 2 weeks. | 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. | ClinicalTrials.gov |
| Secondary | Neuropsychiatric outcome | From the enrollment to the end of treatment at 2 weeks. | \- 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 | ClinicalTrials.gov |
| Secondary | Neuropsychological outcome measure | From the enrollment to the end of treatment at 2 weeks. | \- 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. | ClinicalTrials.gov |
| Secondary | Neuropsychological outcome measure | From the enrollment to the end of treatment at 2 weeks. | 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 | ClinicalTrials.gov |
| Secondary | Neuropsychological outcome measure | From the enrollment to the end of treatment at 2 weeks. | \- Semantic Verbal Fluency (0-...): the patient was asked to say as many words as possible belonging to a given semantic category (colors, animals, fruits, and city) in 2 minutes. High score means a better outcome. | ClinicalTrials.gov |
| Secondary | Neuropsychological outcome measure | From the enrollment to the end of treatment at 2 weeks. | \- Phonological Verbal Fluency (0-...): the patient is asked to produce as many words as possible beginningwith the letters F, A, and S in 1 minute. High score means a better outcome. | ClinicalTrials.gov |
| Secondary | Neuropsychological outcome measure | From the enrollment to the end of treatment at 2 weeks. | \- Raven's Colored Progressive Matrices (0-36): the patient must logically complete a given visual spatial pattern, choosing from a set of six alternatives. This provides a nonverbal measure of intellectual ability. High score means a better outcome. | ClinicalTrials.gov |
| Secondary | Neuropsychological outcome measure | From the enrollment to the end of treatment at 2 weeks. | \- Corsi span Backward (0-9): the same procedure is used for this test, but the subject has to reproduce the sequence of blocks in the reverse order. high score means a better outcome | ClinicalTrials.gov |
| Secondary | Neuropsychological outcome measure | From the enrollment to the end of treatment at 2 weeks. | \- Digit span Backward (0-9): the same procedure is used for this test, but the subject has to reproduce the sequence of digit in the reverse order. High score means a better outcome | ClinicalTrials.gov |
| Secondary | Neuropsychological outcome measure | From the enrollment to the end of treatment at 2 weeks. | \- Digit span Forward (0-9): the subject must repeat the lists of digits of increasing length immediately after presentation. The digit span score is the length of the longest correctly recalled sequence. High score means a better outcome | ClinicalTrials.gov |
| Secondary | Neuropsychological outcome measure | From the enrollment to the end of treatment at 2 weeks. | \- Corsi span Forward (0-9): In a group of nine blocks the examiner taps some in a particular sequence then asks the patient to tap out exactly the same string immediately afterwards. Sequences of increasing length were presented. The spatial span score is the length of the longest sequence correctly recalled. | ClinicalTrials.gov |
| Secondary | Neuropsychological outcome measure | From the enrollment to the end of treatment at 2 weeks. | \- Rey's 15-word Immediate (0-75) and Delayed Recall (0-15): the patient must recall a 15-word list, five times (immediate recall and learning); the sixth recall trial is performed 15 minutes later (delayed recall). High score means a better outcome. | ClinicalTrials.gov |
| Other | Functional cognitive secondary outcome | From the enrollment to the end of treatment at 2 weeks. | 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. | ClinicalTrials.gov |
| Other | Functional secondary outcome | From the enrollment to the end of treatment at 2 weeks. | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Corsi Block-Tapping Test | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Matrix Reasoning | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)