NCT07385508 Neurorehabilitation in Patients With Disorders of Consciousness: Multidimensional Ambispective Study on the Impact of Single and Combined Approaches
| NCT ID | NCT07385508 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Centro Neurolesi Bonino Pulejo |
| Condition | Disorder of Consciousness |
| Study Type | OBSERVATIONAL |
| Enrollment | 140 participants |
| Start Date | 2026-01-16 |
| Primary Completion | 2029-01-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 140 participants in total. It began in 2026-01-16 with a primary completion date of 2029-01-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Disorders of consciousness (DOC), such as the vegetative state/unresponsive wakefulness syndrome (VS/UWS) and the minimally conscious state (MCS), represent severe clinical conditions arising from acquired brain injury (ABI), exerting a profound impact on patients, caregivers, and healthcare systems. The clinical heterogeneity, diagnostic challenges, and paucity of robust evidence on the comparative efficacy of rehabilitation interventions underscore the need for a deeper understanding of the underlying neurophysiological, cognitive, and biological mechanisms involved in consciousness recovery. This monocentric ambispective observational study aims to investigate the effects of advanced neurorehabilitation treatments-including multimodal sensory stimulation, non-invasive neuromodulation via transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (tDCS), and the use of augmentative and alternative communication (AAC) devices with eye-tracking-on various facets of residual consciousness in patients diagnosed with DOC admitted to the Neurorehabilitation Unit of the IRCCS Centro Neurolesi "Bonino Pulejo" in Messina. The study design encompasses the collection of clinical and rehabilitation data from hospitalized patients undergoing treatment, both retrospectively and prospectively. Specifically, data from patients admitted and treated in the 36 months preceding study initiation, as well as those admitted and treated in the subsequent 36 months, will be included. Upon data collection, participants will be classified a posteriori as "responders" or "non-responders" based on whether they meet at least one of the following criteria: (I) an increase of ≥3 points on the Coma Recovery Scale-Revised (CRS-R) from baseline or a clinically relevant state transition (e.g., VS/UWS → MCS; MCS → emergence from MCS \[EMCS\]); (II) an increase of ≥10 points on the Functional Independence Measure (FIM) or ≥0.5 standard deviations (SD) from baseline; (III) an increase of ≥10 points on the Barthel Index or ≥0.5 SD from baseline. The primary objective is to estimate the proportion of responders and non-responders at the end of training or hospitalization. Secondary objectives include identifying variables predictive of treatment response at the end of intervention (training type/modality, aetiology, demographic factors, comorbidities), quantifying the dose-response gradient (number of sessions/session duration versus response probability), and assessing changes in neurophysiological, physiological, and biological parameters collected during hospitalization (neuroimaging examinations, neurofilament light chain \[NfL\] assays, EEG/event-related potentials \[ERP\], skin conductance response, heart rate frequency and variability, and oculomotor activity). Data will be analysed using descriptive statistics appropriate to variable distributions. The primary endpoint, defined as the proportion of responders at the end of training/hospitalization, will be evaluated using logistic regression models in an as-treated approach, reporting odds ratios and marginal estimates (risk ratios and absolute risk differences) with 95% confidence intervals (CI). Confounding will be addressed through multivariable adjustment and propensity score-based methods (inverse probability of treatment weighting \[IPTW\]/overlap weighting). Continuous secondary outcomes will be analysed with linear models or linear mixed-effects models for repeated measures. Dose-response relationships will be explored, alongside sensitivity and subgroup analyses. All analyses will be performed using R software (version 4.4.2), employing two-sided tests with a significance level of α=0.05. The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of VS/MCS following ABI, according to clinical and neuroradiological findings. * Age between 18 and 90 years. * Adequate pulmonary gas exchange function (PaO₂ / FiO₂ ratio ≥ 250). * Stable haemodynamic profile (absence of significant arterial variations in mean arterial pressure and/or heart rate). Exclusion Criteria: * Diagnosis of DOC due to non-structural aetiopathogenesis. * Having previously undergone multiple rehabilitation cycles * Being affected by deafness and/or blindness * Having unstable intracranial pressure values * Having cerebral perfusion values below 60 mmHg * Having other concomitant medical conditions that could interfere with the rehabilitation
Contact & Investigator
Davide Cardile, Psychologist
PRINCIPAL INVESTIGATOR
IRCCS Centro Neurolesi Bonino Pulejo
Frequently Asked Questions
Who can join the NCT07385508 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Disorder of Consciousness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07385508 currently recruiting?
Yes, NCT07385508 is actively recruiting participants. Contact the research team at davide.cardile@irccsme.it for enrollment information.
Where is the NCT07385508 trial being conducted?
This trial is being conducted at Messina, Italy.
Who is sponsoring the NCT07385508 clinical trial?
NCT07385508 is sponsored by IRCCS Centro Neurolesi Bonino Pulejo. The principal investigator is Davide Cardile, Psychologist at IRCCS Centro Neurolesi Bonino Pulejo. The trial plans to enroll 140 participants.