Disorder of ConsciousnessMIMENCT05734183
Multisensorial IMmersive Experiences (MIME) in Disorders of Consciousness
A study testing MIME and MIME + tDCS in people with Disorder of Consciousness and Acquired Brain Injury, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Disorder of Consciousness, Acquired Brain Injury
- What is being tested?
- MIME and MIME + tDCS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 29 Oct 2021to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, 00168
About this study
Official title: Effects of Immersive Multisensory Stimulation 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.
Read the detailed description
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.
- Conditions
- Disorder of Consciousness, Acquired Brain Injury
- Being tested
- MIME, MIME + tDCS
- Keywords
- Disorder of Consciousness, Acquired Brain Injury, Sensory stimulation
- Medical subject headings
- Consciousness Disorders, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIMEOther
Multisensorial IMmersive Experiences
MIME + tDCSOther
Multisensorial IMmersive Experiences plus transcranial direct current stimulation
| Study group | Role | What they receive |
|---|---|---|
| MIME Group | Experimental | Stimulation with MIME will be performed in a large ad hoc room in which video images will be projected on three walls. The patient will be positioned in the center of the room, 3 meters from the front wall, with the back of the bed tilted at a 45-degree angle, so as to obtain a truly immersive view covering the entire 220-degree field of view. Audio stimulation will be achieved through two speakers located at the sides of the room, with the low frequencies reinforced by a subwoofer. The average sound intensity recorded from the patient's position will be 81 db average (maximum 87, minimum 69).
Patients will undergo treatment with MIME once a day for five consecutive days, for a total of two weeks (10 sessions), in addition to conventional treatment. Receives: Other: MIME |
| MIME + tDCS Group | Active comparator | Simultaneously with MIME treatment, patients will undergo transcranial direct current stimulation (tDCS). Stimulation with tDCS will begin 5 minutes after the start of resting phase 1, and the electrodes will be placed as follows: the 5×4 anode (about 20 cm2) will be placed on the left dorsolateral prefrontal area; the reference electrode, 6x5 (about 30 cm2), will instead be placed on the upper arm, specifically at the level of the right deltoid muscle, contralateral to the active electrode. Current will be applied at an intensity of 2 mA, for 20 minutes a day for 2 weeks, five days a week, for a total of 10 sessions. The current density will be kept below the safe limits reported in the literature. Receives: Other: MIME + tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coma Recovery Scale-r (CRS-r)
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.
Measured: Change from baseline CRS-r at 2 weeks
Secondary outcomes (6)
Electrodermal Activity (EDA)
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.
Measured: Change from baseline EDA at 2 weeks
Heart Rate Variability (HRV)
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.
Measured: Change from baseline HRV at 2 weeks
Level of Cognitive Functioning (LCF)
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.
Measured: Change from baseline LCF at 2 weeks
Disability Rating Scale (DRS)
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).
Measured: Change from baseline DRS at 2 weeks
Cognitive Reserve Index questionnaire (CRIq)
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.
Measured: Assess CRIq at baseline
Lifetime Physical Activity Questionnaire (LTPAQ)
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.
Measured: Assess LTAQ at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start29 Oct 2021
- Primary completion30 Apr 2022
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PADUA LUCA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Luca Padua, MD, phD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734183
- Sponsor's protocol ID
- 0038186/21
- Acronym
- MIME
- Status last verified
- Mar 2025
- First submitted
- 6 Feb 2023
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Immersive Multisensory Stimulation in Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT05734183
- Acronym / sponsor ID
- MIME / 0038186/21
- Conditions
- Disorder of Consciousness, Acquired Brain Injury
- Keywords
- Disorder of Consciousness, Acquired Brain Injury, Sensory stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIME Group | Experimental | Other: MIMEStimulation with MIME will be performed in a large ad hoc room in which video images will be projected on three walls. The patient will be positioned in the center of the room, 3 meters from the front wall, with the back of the bed tilted at a 45-degree angle, so as to obtain a truly immersive view covering the entire 220-degree field of view. Audio stimulation will be achieved through two speakers located at the sides of the room, with the low frequencies reinforced by a subwoofer. The average sound intensity recorded from the patient's position will be 81 db average (maximum 87, minimum 69). Patients will undergo treatment with MIME once a day for five consecutive days, for a total of two weeks (10 sessions), in addition to conventional treatment. |
| MIME + tDCS Group | Active comparator | Other: MIME + tDCSSimultaneously with MIME treatment, patients will undergo transcranial direct current stimulation (tDCS). Stimulation with tDCS will begin 5 minutes after the start of resting phase 1, and the electrodes will be placed as follows: the 5×4 anode (about 20 cm2) will be placed on the left dorsolateral prefrontal area; the reference electrode, 6x5 (about 30 cm2), will instead be placed on the upper arm, specifically at the level of the right deltoid muscle, contralateral to the active electrode. Current will be applied at an intensity of 2 mA, for 20 minutes a day for 2 weeks, five days a week, for a total of 10 sessions. The current density will be kept below the safe limits reported in the literature. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIMEMultisensorial IMmersive Experiences | Other | MIME Group |
| MIME + tDCSMultisensorial IMmersive Experiences plus transcranial direct current stimulation | Other | MIME + tDCS Group |
Primary outcome
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.
6 secondary outcomes
Electrodermal Activity (EDA)
Time frame: Change from baseline EDA at 2 weeks
Heart Rate Variability (HRV)
Time frame: Change from baseline HRV at 2 weeks
Level of Cognitive Functioning (LCF)
Time frame: Change from baseline LCF at 2 weeks
Disability Rating Scale (DRS)
Time frame: Change from baseline DRS at 2 weeks
Cognitive Reserve Index questionnaire (CRIq)
Time frame: Assess CRIq at baseline
Lifetime Physical Activity Questionnaire (LTPAQ)
Time frame: Assess LTAQ at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Disorder of Consciousness
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Not yet recruitingPhase 2
Restoring Awareness
Vegetative State, Minimally Conscious State
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Padua, MD, phD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIME and MIME + tDCS in people with Disorder of Consciousness and Acquired Brain Injury, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coma Recovery Scale-r (CRS-r) (time frame: Change from baseline CRS-r at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.