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Completed

NCT Number: NCT05734183

Multisensorial IMmersive Experiences (MIME) in Disorders of Consciousness

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.

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Key information

Conditions

Disorder of Consciousness Acquired Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Consciousness Disorders Craniocerebral Trauma Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00168, Italy

About this study

It can be hypothesized that sensory stimulation, or "Multisensorial IMmersive Experiences" (MIME), enhanced by high-quality video images, a larger screen size, and qualitatively better sound, may have a greater impact on the patient than the same image or video played on a small screen.

The purpose of the study is to evaluate (i) whether MIMEs can clinically modify the vigilance of DoC patients during administration; (ii) whether there is SNA activation during the administration of MIMEs; and (iii) whether patients treated daily with MIMEs have any benefits in terms of vigilance modification.

Twenty patients of both sexes with DoC will be recruited, evaluated and treated at the UOC of High Intensity Neurorehabilitation at the Fondazione Policlinico Universitario Gemelli IRCCS in Rome.

All study participants will undergo MIME treatment once a day for 5 days a week, for a total of 10 sessions. Patients will perform, in addition to MIME therapy, conventional rehabilitation as a daily routine. Patients will be divided into two groups: one part will perform MIME treatment concurrently with transcranial direct current stimulation (tDCS, G-Mt) and as many will undergo MIME treatment alone (G-M), as described below. In the case of epileptic subjects, these due to contraindications to tDCS may be subjected to MIME therapy only.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 consent

Exclusion 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.

Treatment and study plan

MIME

Other

Multisensorial IMmersive Experiences

MIME + tDCS

Other

Multisensorial IMmersive Experiences plus transcranial direct current stimulation

Primary outcomes

  1. Coma Recovery Scale-r (CRS-r)

    Time frame: Change from baseline CRS-r at 2 weeks

    CRS-r is an assessment tool that examines 6 functions: auditory, visual, oral-verbal motor, communicative, and vigilance.

    Its different items are organized hierarchically (low scores represent reflex activities, high scores describe cognitively mediated behaviors).

    For each function examined, the diagnosis of Vegetative State, Minimal Consciousness State, Emergence from Minimal Consciousness State can be made.

Secondary outcomes

  1. Electrodermal Activity (EDA)

    Time frame: Change from baseline EDA at 2 weeks

    The E4 wearable medical device (Empatica, EDA) will be used to assess the electrodermal activity (EDA).

    Fluctuations in some electrical properties of the skin will be recorded; the online software Empatica (https://www.empatica.com/en-eu/) will then export the recorded data.

    A higher EDA value corresponds to a higher stress level.

  2. Heart Rate Variability (HRV)

    Time frame: Change from baseline HRV at 2 weeks

    HRV, that is, the assessment of heart rate variability, is evaluated using an electrocardiographic (ECG) device with normal surface electrodes applied at the level of the heart and special software for data analysis.

  3. Level of Cognitive Functioning (LCF)

    Time frame: Change from baseline LCF at 2 weeks

    LCF is a tool that assesses the level of cognitive and behavioural recovery. It consists of 7 items ranging from 1=no response to 8=final-appropriate.

  4. Disability Rating Scale (DRS)

    Time frame: Change from baseline DRS at 2 weeks

    DRS is an assessment tool for level of consciousness and functional recovery. It consists of four domains:

    (i) Vigilance, awareness and responsiveness (0 to 12 points) (ii) Cognitive ability for self-care activities (0 to 9 points) (iii) Functional level (0 to 5 points) (iv) employability (0 to 3 points). A higher score corresponds to greater disability. The overall score ranges from 0 to 30 and allows the identification of 10 categories ranging from category 1 (no disability) to category 10 (death).

  5. Cognitive Reserve Index questionnaire (CRIq)

    Time frame: Assess CRIq at baseline

    The CRIq questionnaire evaluates the cognitive reserve of an individual by means of the compilation of information relating to his or her entire adult life. The questionnaire is divided into 3 sections: CRI-Education, CRI-WorkingActivity, CRI-LeisureTime.

    CRI-Education: this section records the level of education reached by an individual during his/her life. For each school year successfully completed, 1 point is assigned, whereas 0.5 points are assigned for each year that the individual was forced to repeat.

    CRI-WorkingActivity: this section records the type and number of years of work carried out by an individual.

    CRI-LeisureTime: this section refers to all of those activities that are normally carried out before or after the person concerned goes to work or school. The items included indicate the activity for which it is necessary to estimate the frequency within the given time interval.

  6. Lifetime Physical Activity Questionnaire (LTPAQ)

    Time frame: Assess LTAQ at baseline

    LTPAQ is a questionnaire that collects information pertaining lifetime PA. It consists of three different sections: (i) Occupational and Volunteer Activities, (ii) Family Activities, and (iii) Exercise and Sports Activities.

    (i) Occupational and Volunteer Activities, the individual must indicate those jobs, paid or voluntary, that he/she has held for at least 8 hours per week for 4 months of the year.

    (ii) Family Activities, each individual must indicate the household, do-it-yourself, and gardening activities performed over a lifetime, for at least 7 hours per week for 4 months per year. Childcare is included in this section and sedentary activities are excluded.

    (iii) Exercise & Sports Activities, each individual must list all physical activity or sports he/she has done throughout his/her life since childhood, reporting activities he/she has done at least 2 hours per week for 4 months per year.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Effects of Immersive Multisensory Stimulation in Disorders of Consciousness

Acronym: MIME

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Feb 17, 2023
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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