Spatiotemporal Entrainment Neuromodulation Targeting Cerebello-Cerebral Circuits to Enhance Cognitive and Social Rehabilitation in Cerebellar Diseases
NCT07500103, Not applicable, Recruiting, I.R.C.C.S. Fondazione Santa Lucia
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Spatiotemporal Entrainment Neuromodulation Targeting Cerebello-Cerebral Circuits to Enhance Cognitive and Social Rehabilitation in Cerebellar Diseases | ClinicalTrials.gov |
| NCT number | NCT07500103 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | I.R.C.C.S. Fondazione Santa Lucia | ClinicalTrials.gov |
| Conditions | Cerebellar Degeneration, Cerebellar Malformation | ClinicalTrials.gov |
| Interventions | EEg-guided High-Definition transcranial alternate current stimulation (HD-tACS), Immersive Virtual Reality (IVR) Social Prediction training | ClinicalTrials.gov |
| First posted | 2026-03-30 | ClinicalTrials.gov |
| Last updated | 2026-03-30 | ClinicalTrials.gov |
Registered outcomes 22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Context-based social prediction task | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), two months after the end of the training (t2) | Behavioral responses (accuracy and reaction times) to three ad-hoc computer-assisted social prediction tasks and one non-social control task. The three social prediction tasks measure the ability to use contextual information to infer and predict others' mental states or traits, including action intentions, emotional states, and personality traits. All tasks share a priming-target procedure where participants select between two interpretations of a target stimulus following a congruent or incongruent situational context. Specifically, the Action Intention task requires predicting if a hand-grasp is for using or moving an object; the Emotion task involves identifying happiness or fear in facial expressions; and the Personality Trait task assesses trustworthiness judgments based on moral or immoral behaviors. A Non-social Control task requiring the classification of natural or artificial objects in indoor/outdoor environments is used as a control. | ClinicalTrials.gov |
| Secondary | Cognitive discrimination response task (DRT) | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1) | This computer-assisted task is used as an index of perceptual and cognitive control, such as inhibition, a core executive function supporting social cognition. Participants respond quickly to target stimuli and withhold responses to non-target stimuli. | ClinicalTrials.gov |
| Secondary | High-density event-related potentials (ERPs) recording | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1) | ERPs are measured during the DRT, to examine pre- and post-stimulus activity, capturing reactive sensory-motor processes, proactive motor preparation, and cognitive anticipation | ClinicalTrials.gov |
| Secondary | Cortical rhythms | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1) | EEG recordings are collected at rest (5 minutes) and during the DRT (15 minutes) to assess changes in delta, alpha, beta, and gamma power across time points, focusing on regions linked to socio-cognitive functions | ClinicalTrials.gov |
| Secondary | NEPSY-II: Social Perception | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), two months after the end of the training (t2) | For participants ≤16 years, a domain-specific Composite Score is calculated as the arithmetic mean of the age-standardized scaled scores (Mean=10, SD=3; range 1-19) of the administered subtests. It assesses the ability to recognize facial affect and understand mental states (Theory of Mind). | ClinicalTrials.gov |
| Secondary | NEPSY-II: Attention and Executive Functioning | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), two months after the end of the training (t2) | For participants ≤16 years, a domain-specific Composite Score is calculated as the arithmetic mean of the age-standardized scaled scores (Mean=10, SD=3; range 1-19) of the administered subtests. It evaluates selective attention, inhibitory control, and cognitive flexibility. | ClinicalTrials.gov |
| Secondary | NEPSY-II: Language | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), two months after the end of the training (t2) | For participants ≤16 years, a domain-specific Composite Score is calculated as the arithmetic mean of the age-standardized scaled scores (Mean=10, SD=3; range 1-19) of the administered subtests. It assesses phonological awareness, verbal retrieval, and receptive language. | ClinicalTrials.gov |
| Secondary | NEPSY-II: Memory and Learning | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), two months after the end of the training (t2) | For participants ≤16 years, a domain-specific Composite Score is calculated as the arithmetic mean of the age-standardized scaled scores (Mean=10, SD=3; range 1-19) of the administered subtests. It measures immediate and delayed recall for both verbal and visuospatial information. | ClinicalTrials.gov |
| Secondary | NEPSY-II: Sensorimotor functions | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), two months after the end of the training (t2) | For participants ≤16 years, a domain-specific Composite Score is calculated as the arithmetic mean of the age-standardized scaled scores (Mean=10, SD=3; range 1-19) of the administered subtests. It evaluates fine motor coordination, finger dexterity, and visuomotor precision. | ClinicalTrials.gov |
| Secondary | NEPSY-II: Visuospatial Processing | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), two months after the end of the training (t2) | For participants ≤16 years, a domain-specific Composite Score is calculated as the arithmetic mean of the age-standardized scaled scores (Mean=10, SD=3; range 1-19) of the administered subtests. It measures visual-perceptual analysis, orientation, and mental rotation. | ClinicalTrials.gov |
| Secondary | Reading the Mind in the Eyes Test (RMET) | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), two months after the end of the training (t2) | For participants \>16 years, an advanced test of Theory of Mind and social intelligence is administered. The outcome is the total number of correctly identified mental states from photographs of the eye region. | ClinicalTrials.gov |
| Secondary | Faux Pas Recognition Test | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), two months after the end of the training (t2) | For participants \>16 years, a measure of social cognition and the ability to detect social "faux pas" is administered. Outcomes include total scores for detecting, identifying, and explaining social transgressions. | ClinicalTrials.gov |
| Secondary | Albert Test | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), two months after the end of the training (t2) | For participants \>16 years, a screening task for visual attention is administered. The outcome is typically reported as the number of lines crossed or a omission score, assessing spatial attention and orientation. | ClinicalTrials.gov |
| Secondary | Stroop Test | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), two months after the end of the training (t2) | For participants \>16 years, a measure of selective attention and cognitive inhibition iss administered. Outcomes include completion time and error rates across three conditions (Word, Color, and Color-Word interference). | ClinicalTrials.gov |
| Secondary | Token test | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), two months after the end of the training (t2) | For participants \>16 years, a measure of receptive language and oral command comprehension is administered. The outcome is the total number of correct responses (maximum score varies by version, e.g., 36 or 62). | ClinicalTrials.gov |
| Secondary | Rey Auditory Verbal Learning Test (RAVLT) | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), two months after the end of the training (t2) | For participants \>16 years, an assessment of verbal learning and memory is administered. Outcomes include Immediate Recall (sum of trials 1-5), Delayed Recall (after 20-30 min), and Recognition scores. | ClinicalTrials.gov |
| Secondary | Rey-Osterrieth Complex Figure | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), two months after the end of the training (t2) | For participants \>16 years, a measure of visuospatial construction and visual memory is administered. Outcomes are accuracy scores (0-36 points). | ClinicalTrials.gov |
| Secondary | WAIS-IV: Block Design | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), two months after the end of the training (t2) | For participants \>16 years, a subtest measuring visuospatial organization, non-verbal reasoning, and visual-motor integration is administered. The outcome is reported as an age-standardized scaled score (Mean=10, SD=3). | ClinicalTrials.gov |
| Secondary | International Cooperative Ataxia Rating Scale (ICARS) | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), two months after the end of the training (t2) | For participants ≥ 18 years, a semi-quantitative clinical scale (0-100 points) is used to assess the severity of cerebellar ataxia. It evaluates four subdomains: posture and gait, limb coordination, speech disorders, and oculomotor disorders. Higher scores indicate greater impairment. | ClinicalTrials.gov |
| Secondary | Cerebellar Cognitive Affective Syndrome Scale (CCAS) | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), two months after the end of the training (t2) | For participants ≥ 18 years, a specialized screening tool is administered to detect cognitive and behavioral deficits associated with cerebellar lesions. It assesses executive function, linguistic processing, visuospatial abilities, and emotional regulation. | 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 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 42550853 | DERIVED | PubMed |
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 8
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 |
|---|---|---|
| Face Impressions Task | Primary outcome | ConductCognition |
| Complex Figure Copy and Recall | Secondary outcome | ConductCognition |
| Matrix Reasoning | Secondary outcome | ConductCognition |
| Mental Rotation | Secondary outcome | ConductCognition |
| Social Slips Stories Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Token Commands Task | Secondary outcome | ConductCognition |
| Verbal Learning | 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)