Clinical trial Recruiting at 1 site Observational Ages 18 to 90

Neurorehabilitation for Disorders of Consciousness: How Different Approaches May Help Recovery

Official title: Neurorehabilitation in Patients With Disorders of Consciousness: Multidimensional Ambispective Study on the Impact of Single and Combined Approaches

Run by IRCCS Centro Neurolesi Bonino Pulejo · NCT07385508 · Data updated 2026-11-12

This study tests whether combining multimodal sensory stimulation, non-invasive brain stimulation, and eye-tracking AAC can help people with disorders of consciousness recover awareness and function.

More Disorder of Consciousness trials

Quick facts

Study typeObservational
Ages18 Years to 90 Years
SexAll
Enrollment140 (estimated)
SponsorIRCCS Centro Neurolesi Bonino Pulejo
Academic / other
Locations1 site (Messina, Sicily)
StatusRecruiting
StartedJanuary 16, 2026
Main results expectedJanuary 16, 2029
Study endsJanuary 16, 2029
Registry record updatedMay 27, 2026
Trial IDNCT07385508 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–90 with VS or MCS after acquired brain injury, medically stable and able to participate in neurorehabilitation.

Probably not a fit

Patients with non-structural DOC etiologies, significant medical instability, or sensory impairments limiting participation may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This ambispective observational study follows patients with vegetative state or minimally conscious state to explore how advanced neurorehabilitation approaches affect arousal, awareness, communication, and autonomy. It evaluates multimodal sensory stimulation, non-invasive brain stimulation (TMS or tDCS), and augmentative/alternative communication with eye-tracking as a combined strategy. Data will be collected from a single center to correlate neurophysiological, neuroimaging, and biological markers with clinical outcomes. The aim is to understand mechanisms of recovery and identify factors associated with better responses beyond standard care. The study recognizes the diagnostic challenges in DOC and seeks to improve measurement of residual consciousness using objective biomarkers alongside behavioural assessment.

Why it matters

Potential benefit: If successful, the approach could improve detection of consciousness and enhance rehabilitation outcomes for patients with DOC.

How similar studies have gone: Previous work suggests potential benefits of multimodal stimulation and non-invasive neuromodulation in DOC, but evidence remains limited and more data are needed.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • IRCCS Centro Neurolesi Bonino-Pulejo
    Messina, Sicily, Italy
    Recruiting

Study contacts

  • Principal investigator: Davide Cardile, Psychologist — IRCCS Centro Neurolesi Bonino Pulejo
  • Study coordinator: Davide Cardile, Psychologist
  • Email: davide.cardile@irccsme.it
  • Phone: 090 6012 8417

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.