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Active Not Recruiting NCT05734183

Multisensorial IMmersive Experiences (MIME) in Disorders of Consciousness

Conditions: Disorder of Consciousness, Acquired Brain Injury

Sex: All
Ages: 18 Years – 90 Years
Phase: NA
Enrollment: 20
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Location: Italy

Summary

Disorder of consciousness (DoC) is a state in which consciousness is altered because of brain damage and can occur under a variety of conditions: in fact, the most frequent causes of DoC are vascular disease, head trauma, and cerebral hypoxia. DoCs result from the loss of regulation of neural function of the two components of consciousness, alertness and awareness. Depending on the patient's behavior and responsiveness, DoCs can be identified in different states, from coma to persistent vegetative state (VS) to intermittent minimally conscious state (MCS). Regarding the prognosis of recovery, in patients with DoC the chance of having functional improvement decreases with time, although some positive functional changes have been observed in chronic patients. Therapies for DoC include some drugs, such as dopaminergic, GABAergic and amantadine drugs, which work to facilitate the recovery of consciousness. Neurorehabilitation, however, seems to be the most recognized intervention that aims to strengthen, in uninjured brain regions, the spontaneous neuroplasticity that occurs to compensate for lost function.Simultaneous stimulation of multiple senses, such as hearing, sight and smell, provides the neural network with more stimuli that are more effective than a single stimulus. In fact, multisensory stimuli can more easily activate attention because cortical processing is predominantly multimodal. As for content, it would seem that those with autobiographical and emotionally salient character could engage multiple brain networks and have priority access to attention. Numerous trials show that stimulus-containing content led to increased behavioural activity, improving self-awareness in patients with DoC.Considering that a communication system that can combine both visual and auditory channels proves to be more effective than a "single-sense" channel, multisensory stimulation is likely to provide simultaneous activation of different brain areas by enhancing plasticity processes. Furthermore, the intensity of stimulation could be one of the main variables with greater impact on the patient: in fact, higher intensity would correspond to a greater effect on the brain.

Eligibility Criteria

Inclusion Criteria:Age between 18 and 90 years Patients who have been in a coma state and have alterations in consciousness Patients who are not responsive to rehabilitative treatment of disorders of consciousness, such as environmental stimulation, non-invasive brain stimulation, or drug treatment.Clinical stability Ability of caregiver/legal guardian to understand and sign informed consentExclusion Criteria:Taking medications that interfere with membrane conductivity (e.g., calcium channel blockers, antiepileptic drugs).Psychiatric or other medical conditions Failure to sign informed consent The presence of a history of epilepsy and/or taking antiepileptic therapy is an exclusion criterion for assignment to the MIME+tDCS group.

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Source: ClinicalTrials.gov (NCT05734183). StuddyBuddy aggregates publicly available trial information.