--- title: Eye-tracking Technology for Severe Communication Disability nct_id: NCT05808478 overall_status: RECRUITING phase: NA sponsor: IRCCS Centro Neurolesi Bonino Pulejo study_type: INTERVENTIONAL primary_condition: Communication Disabilities countries: Italy canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05808478.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05808478" ct_last_update_post_date: 2023-04-11 last_seen_at: "2026-05-12T06:45:48.085Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Eye-tracking Technology for Severe Communication Disability **Official Title:** Augmentative Alternative Communication Intervention Delivered Via Eye-tracking Technology **NCT ID:** [NCT05808478](https://clinicaltrials.gov/study/NCT05808478) ## Key Facts - **Status:** RECRUITING - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 30 - **Lead Sponsor:** IRCCS Centro Neurolesi Bonino Pulejo - **Conditions:** Communication Disabilities - **Start Date:** 2022-01-22 - **Completion Date:** 2026-12-31 - **CT.gov Last Update:** 2023-04-11 ## Brief Summary The aim of this project is to develop an Augmentative and Alternative Communication intervention through the use of Eye tracker system. ## Detailed Description The term "complex communication needs" includes all patients who present severe disturbances in speech and language production and/or in comprehension, in relation to oral or written communication modalities. The main purpose of Augmentative and Alternative Communication (AAC) is to promote the best possible communication for people with complex communication needs, through the use of techniques, methods and tools aimed not at replacing pre-existing communication methods but at increasing skills of natural communication through the enhancement of present skills. The Eye tracker system, thanks to allows the recording and analysis of eye movements, could be used successfully to support communication in patients with severe communication disability. The goal of this study is to develop an efficacy Augmentative and Alternative Communication intervention using eye-tracking technology for patients with severe communication disability. The secondary objective was to examine the psychosocial impact of technology for AAC on parents' perspectives and quality of life. ## Eligibility - **Minimum age:** 3 Years - **Maximum age:** 17 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * aged between 3 and 17 years affected by neuropsychiatric pathology presenting complex communication needs * Control of eye motility and visual fixation * ability to maintain position in front of the monitor * availability of at least one member of the family nucleus to participate in the therapeutic process * cognitive skills appropriate to the task such as being able to recognize images and being able to memorize procedures necessary to use the various basic functions Exclusion Criteria: * age not between 3 and 17 years * difficulty in controlling ocular motility and visual fixation * the unavailability of at least one member of the family nucleus to participate in the therapeutic process * impaired cognitive skills on the task such as being able to recognize pictures and being able to memorize procedures necessary to use various basic functions ``` ## Arms - **Experimental Group (EG)** (EXPERIMENTAL) — The experimental group will undergo treatment with innovative high-tech tools, such as Eye Tracking, for communication purposes. The duration of the treatment will be six months, twice a week, with sessions of 45 minutes. - **Control Group (CG)** (ACTIVE_COMPARATOR) — The control group will undergo conventional AAC treatment, with low-tech tools, such as PECS or sign language. The duration of the treatment will be six months, twice a week, with sessions of 45 minutes. ## Interventions - **AAC + Eye Tracking** (BEHAVIORAL) — The AAC treatment will be supported by the use of an innovative high-tech tool, such as Eye Tracking. The duration of treatment will be 6 months, with sessions of 45 minutes twice a week. - **AAC** (BEHAVIORAL) — Treatment involves the use of conventional AAC, with low-tech tools, such as PECS or sign language. The duration of treatment will be six months, twice a week, with sessions of 45 minutes. ## Primary Outcomes - **MacArthur-Bates Communicative Development Inventory** _(time frame: Month 0)_ — The MacArthur-Bates Communicative Development Inventory is a questionnaire for parents. This is used for the study and evaluation of communication and language in children with typical and atypical development. - **MacArthur-Bates Communicative Development Inventory** _(time frame: Month 3)_ — The MacArthur-Bates Communicative Development Inventory is a questionnaire for parents. This is used for the study and evaluation of communication and language in children with typical and atypical development. - **MacArthur-Bates Communicative Development Inventory** _(time frame: Month 6)_ — The MacArthur-Bates Communicative Development Inventory is a questionnaire for parents. This is used for the study and evaluation of communication and language in children with typical and atypical development. - **Communication Matrix** _(time frame: Month 0)_ — is an online assessment tool created to help professionals and family members support people with severe communication disorders on their journey to greater self-expression. Total score on an assessment of early expressive communication skills. - **Communication Matrix** _(time frame: Month 3)_ — is an online assessment tool created to help professionals and family members support people with severe communication disorders on their journey to greater self-expression. Total score on an assessment of early expressive communication skills. - **Communication Matrix** _(time frame: Month 6)_ — is an online assessment tool created to help professionals and family members support people with severe communication disorders on their journey to greater self-expression. Total score on an assessment of early expressive communication skills. - **Interactive Check list for Augmentative Communication** _(time frame: Month 0)_ — Interactive Check list for Augmentative Communication is an observational tool for evaluating interactive behavior - **Interactive Check list for Augmentative Communication** _(time frame: Month 3)_ — Interactive Check list for Augmentative Communication is an observational tool for evaluating interactive behavior - **Interactive Check list for Augmentative Communication** _(time frame: Month 6)_ — Interactive Check list for Augmentative Communication is an observational tool for evaluating interactive behavior ## Secondary Outcomes - **The World Health Organization Quality of Life** _(time frame: T0 (Baseline) - T1 (3 months) - T2 (6 months))_ - **Parenting Stress Index** _(time frame: T0 (Baseline) - T1 (3 months) - T2 (6 months))_ - **Forerunners in Communication - ComFor** _(time frame: T0 (Baseline) - T1 (3 months) - T2 (6 months))_ - **Vineland Adaptive Behavior Scales II** _(time frame: T0 (Baseline) - T1 (3 months) - T2 (6 months))_ ## Locations (1) - IRCCS Neurolesi Bonino Pulejo, Messina, Italy — _RECRUITING_ ## Recent Field Changes (last 30 days) - `results.hasResults` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `locations.irccs neurolesi bonino pulejo|messina||italy` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT05808478.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT05808478* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*