Disorders of ConsciousnessINES_ABINCT06204172
Intensive Neurowave Emotional Stimulation (INES)
A study testing Intensive Neurowave Emotional Stimulation (INES) and Intensive Sensorial Emotional Stimulation (ISES) in people with Disorders of Consciousness, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial summary
This is a randomized and controlled pilot study investigating the effects of intensive emotional stimulation with neurological waves (INES) on cognitive-motor functions in patients diagnosed with Vegetative State (VS) and Minimally Conscious State (MCS) following severe brain injury. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Disorders of Consciousness
- What is being tested?
- Intensive Neurowave Emotional Stimulation (INES) and Intensive Sensorial Emotional Stimulation (ISES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 14 Dec 2023to 30 Mar 2025
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age between 18 and 65 years.
- Glasgow Coma Scale (GCS) > 8.
- Level of Cognitive Scale (LCF) = 1-3.
- Consent is signed by the legal guardian.
Who cannot join
- Age < 18 years or > 65 years.
- Lack of consent from the legal guardian.
- Patients with cranial anatomical alterations hindering proper electrode, headset, etc., placement.
- Patients showed no neurophysiological responses in visual evoked potentials (VEP) and no V wave in auditory evoked potentials (AEP).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intensive Neurowave Emotional Stimulation (INES): A Pioneering RCT Investigating Cognitive-Motor Impact in Consciousness Disorders Post Severe Brain Injury
This is a randomized and controlled pilot study investigating the effects of intensive emotional stimulation with neurological waves (INES) on cognitive-motor functions in patients diagnosed with Vegetative State (VS) and Minimally Conscious State (MCS) following severe brain injury. The study aims to enroll at least 20 patients aged between 18 and 65 over 18 months. Patients will be recruited from the Neurorehabilitation Unit of Piedmont Hospital, IRCCS Centro Neurolesi Bonino Pulejo in Messina. The experimental group will receive multisensory stimulation using Neurowave (INES) for four weeks, five days a week, 45 minutes per session. The control group will undergo a traditional multisensory stimulation program.
Enrollment will use simple random sampling to minimize bias. Caregivers will provide biographical information, and both groups will be monitored using event-related potentials. Clinical scales will evaluate cognitive-motor outcomes at different time points. The study includes a one-month follow-up to assess long-term results. Data will be collected and exported for statistical analysis.
Read the detailed description
This study aims to investigate the cognitive-motor effects of emotionally significant advanced multisensory stimulation (INES) in patients diagnosed with Vegetative State (VS) and Minimally Conscious State (MCS) following severe acquired brain injury. Primary objectives include exploring short- and long-term efficacy through clinical-psychometric follow-up and examining potential correlations between neurophysiological and clinical-psychometric parameters as predictive indices of recovery.
The secondary objectives concern the implementation of highly specialized technological innovations in current clinical practice, and evaluating the rehabilitation effectiveness of advanced treatment with Neurological Waves.
Therefore, the study aims to develop models and protocols for multisensory rehabilitation stimulation and evaluate the synergies between different stimulation modalities and advanced cognitive electrophysiology techniques. Furthermore, the research aims to promote clinical investigations and systematic monitoring of post-acute patients, focusing on the quantitative analysis of EEG and Cognitive Evoked Potentials to unconventional sensory stimuli with emotionally significant content. The study also deepens the understanding of the role of the metabolic-nutritional state in the cognitive-motor recovery of patients with disorders of consciousness.
The present study is a randomized controlled pilot study, with an interventional, non-pharmacological, and single-center design.
Materials and methods:
The study will consecutively enroll at least 20 adult subjects diagnosed with disorders of consciousness at the Neurorehabilitation Unit of the Piedmont Hospital. Comprehensive multidimensional assessments will be conducted at baseline (T0), followed by an intensive one-month course of advanced multisensory training using Neurowave (INES) for the experimental group and conventional multisensory stimulation (ISES) for the control group. Evaluation at the end of each training cycle (T1) and a one-month follow-up (T2) will provide information on long-term results.
Inclusion criterion:
Participants must be between the ages of 18 and 65, with a Glasgow Coma Scale (GCS) score greater than 8 and a Cognitive Scale Level (LCF) between 1 and 3. Informed consent must be obtained from their legal guardian.
Exclusion criteria:
Exclusion criteria include individuals outside the specified age range, lack of legal guardian consent, anatomical alterations that prevent the correct placement of electrodes, and absence of neurophysiological responses in visual and auditory evoked potentials.
Registration start and end dates:
The study implementation period is expected to be from December 2023 to March 2025, with a total study duration of 18 months.
- Conditions
- Disorders of Consciousness
- Being tested
- Intensive Neurowave Emotional Stimulation (INES), Intensive Sensorial Emotional Stimulation (ISES)
- Keywords
- Multisensory Stimulation, Acquired Brain Injury, Cognitive-Motor rehabilitation, Disorders of Consciousness, Metabolic-Nutritional Status
- 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.
Intensive Neurowave Emotional Stimulation (INES)Device
Also called Intensive Sensorial Emotional Stimulation (ISES)
Patients will undergo Neurowave-assisted multisensory stimulation five days a week for four weeks, featuring emotionally significant audio-visual content tied to personal history. Control group participants will experience primary auditory stimulation through familiar sounds, following a traditional rehabilitation approach mimicking the experimental group's frequency and intensity but without Neurowave use. This allows for a meaningful comparison of the two groups' experiences.
Intensive Sensorial Emotional Stimulation (ISES)Other
Also called traditional rehabilitation
The Intensive Sensorial Emotional Stimulation (ISES) in the control group involves primary auditory stimulation with emotionally rich everyday sounds, including familiar voices, favorite songs, and sounds related to daily life and past activities. It mimics the experimental group's frequency and intensity, lasting 45 minutes per session, five days a week, for four weeks. Unlike the experimental group using Neurowave, the control group follows a traditional rehabilitation approach with paper materials, live photos, face-to-face interaction, and classic music tapes, facilitating a meaningful comparison between the two groups' experiences.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | patients will receive Neurowave multisensory stimulation with concurrent event-related potential acquisition. This intensive training spans five days a week over four weeks, with each session lasting 45 minutes, summing up to 20 sessions. During each session, participants will encounter personalized visual and auditory stimuli. Neurowave treatment comprises an intensive intervention, presenting emotionally significant audio-visual content linked to the patient's life history. Within Neurowave use, visual stimuli will be complemented by primary auditory stimulation, involving exposure to emotionally charged everyday sounds. Receives: Device: Intensive Neurowave Emotional Stimulation (INES) |
| Control group | Active comparator | Participants will receive primary auditory stimulation featuring familiar and emotionally evocative everyday sounds. This involves exposure to audio tapes and sounds related to their daily life, including voices of family and friends, snippets of favorite songs, and sounds associated with past work or leisure activities. The control group will undergo a program called Intensive Sensorial Emotional Stimulation (ISES), matching the frequency, intensity, and session duration of the experimental group but without Neurowave system utilization. Distinctively, the control group will not utilize Neurowave technology. Instead, they will follow a traditional rehabilitation approach incorporating paper materials, live photos, face-to-face interaction with the therapist, and the conventional listening of music tapes. This method aims to replicate an emotionally engaging environment, serving as a comparative reference to the experimental group's Neurowave-assisted experience. Receives: Other: Intensive Sensorial Emotional Stimulation (ISES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive-Motor Functional Improvement Score
The "Cognitive-Motor Functional Improvement Score" is a composite index designed to assess the enhancement of cognitive and motor functions in study participants. This score takes into account various clinical and psychometric measurements, including parameters such as the Glasgow Coma Scale (GCS), the Glasgow Outcome Scale (GOS), the Level of Cognitive Functioning (LCF), the Coma Recovery Scale-Revised (CRS-R), the Disability Rating Scale (DRS), and the Functional Communication Scale (FCS). The score reflects the progression in cognitive and motor abilities of patients before, during, and after the treatment, providing a comprehensive measure of the success of the rehabilitation intervention.
Measured: clinical and psychometric scales will be administered to patients before starting sensory stimulation treatment (time T0), at the end of the stimulation cycle after 4 weeks (time T1), and one month after T1 (follow-up - Time T2).
Examine Short and Long-Term Efficacy
Examine the correlation between neurophysiological and clinical-psychometric parameters to monitor the long-term cognitive-motor effects of advanced multisensory training in individuals with disorders of consciousness, identifying potential predictive indices of recovery. Assessment Method: Clinical evaluations and psychometric tests focusing on cognitive-motor, neurophysiological, and metabolic-nutritional outcomes. Timing: Short-term assessments post-training (T1) and long-term follow-up one month after treatment completion (T2).
Measured: clinical and psychometric scales will be administered to patients before starting sensory stimulation treatment (time T0), at the end of the stimulation cycle after 4 weeks (time T1), and one month after T1 (follow-up - Time T2).
Secondary outcomes (2)
Study Neurophysiological and Clinical Correlations
The comprehensive evaluation includes continuous clinical monitoring, electroencephalographic (EEG) assessments, and metabolic-nutritional evaluations. The goal is to establish meaningful correlations contributing to predictive indices for long-term cognitive-motor recovery in individuals with consciousness disorders. Evaluation: Clinical Monitoring: Continuous assessment of clinical and psychometric parameters. Electroencephalographic (EEG) Assessments: Recording and analysis of EEG data to monitor neurophysiological responses.
Timing: Pre-treatment (T0): Baseline assessment before the commencement of advanced multisensory training. Post-treatment (T1): Evaluation immediately after the completion of the training program.
Follow-up (T2): Long-term assessment one month after the conclusion of the treatment to gauge sustained effects and correlations.
Measured: clinical and psychometric scales will be administered to patients before starting sensory stimulation treatment (time T0), at the end of the stimulation cycle after 4 weeks (time T1), and one month after T1 (follow-up - Time T2).
Explore the Role of Metabolic-Nutritional Status
This outcome measure investigates the influence of metabolic-nutritional status on cognitive-motor recovery in patients with consciousness disorders. Through a specialized early assessment, it aims to deepen our understanding of how factors such as BMI, creatinine/height, albumin, total proteins, and lymphocyte count contribute to the overall recovery process. The study seeks to unravel the intricate interplay between metabolic-nutritional health and cognitive-motor outcomes in individuals undergoing advanced multisensory training, providing valuable insights for tailored interventions.
Measured: clinical and psychometric scales will be administered to patients before starting sensory stimulation treatment (time T0), at the end of the stimulation cycle after 4 weeks (time T1), and one month after T1 (follow-up - Time T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start14 Dec 2023
- Primary completion14 Dec 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Disorders of ConsciousnessStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study adopts a Randomized Controlled Pilot design, an interventional, non-pharmacological, monocentric approach, aiming to explore cognitive-motor effects using advanced multisensory stimulation, the Neurowave system. Enrollment of at least 20 eligible subjects will occur consecutively at the Neurorehabilitation Unit of Piedmont Hospital. The study entails comprehensive baseline assessments (T0), succeeded by a one-month intensive cycle of advanced multisensory training. The experimental group will undergo Neurowave (INES) stimulation, while the control group will receive conventional multisensory stimulation (ISES - Intensive Sensorial Emotional Stimulation) without the advanced technological tool. Evaluations after each training cycle (T1) and a one-month follow-up (T2) will yield insights into short-term and long-term outcomes encompassing clinical-psychometric, neurophysiological, and metabolic-nutritional dimensions.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Grazia Maggio, IRCCS Centro Neurolesi Bonino Pulejo
- Investigators
- Maria Grazia Maggio, Principal investigator, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204172
- Sponsor's protocol ID
- 02/2023
- Acronym
- INES_ABI
- Status last verified
- Apr 2026
- First submitted
- 15 Dec 2023
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We plan to make individual participant data (IPD) available to other researchers. This means that we intend to publish the databases, allowing access for other researchers to utilize the individualized data collected from each participant in our study. By doing so, we aim to contribute to the broader scientific community, fostering collaboration and enabling further exploration and analysis of the information gathered during our research.
Publications
Sergent C, Faugeras F, Rohaut B, Perrin F, Valente M, Tallon-Baudry C, Cohen L, Naccache L. Multidimensional cognitive evaluation of patients with disorders of consciousness using EEG: A proof of concept study. Neuroimage Clin. 2016 Dec 10;13:455-469. doi: 10.1016/j.nicl.2016.12.004. eCollection 2017.
PubMed 28116238Padilla R, Domina A. Effectiveness of Sensory Stimulation to Improve Arousal and Alertness of People in a Coma or Persistent Vegetative State After Traumatic Brain Injury: A Systematic Review. Am J Occup Ther. 2016 May-Jun;70(3):7003180030p1-8. doi: 10.5014/ajot.2016.021022.
PubMed 27089287Lombardi F, Taricco M, De Tanti A, Telaro E, Liberati A. Sensory stimulation for brain injured individuals in coma or vegetative state. Cochrane Database Syst Rev. 2002;2002(2):CD001427. doi: 10.1002/14651858.CD001427.
PubMed 12076410Keller I, Hulsdunk A, Muller F. The influence of acoustic and tactile stimulation on vegetative parameters and EEG in persistent vegetative state. Funct Neurol. 2007 Jul-Sep;22(3):159-63.
PubMed 17925166
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Neurowave Emotional Stimulation (INES): A Pioneering RCT Investigating Cognitive-Motor Impact in Consciousness Disorders Post Severe Brain Injury
- ClinicalTrials.gov ID
- NCT06204172
- Acronym / sponsor ID
- INES_ABI / 02/2023
- Conditions
- Disorders of Consciousness
- Keywords
- Multisensory Stimulation, Acquired Brain Injury, Cognitive-Motor rehabilitation, Disorders of Consciousness, Metabolic-Nutritional Status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 14 Dec 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 12 Jan 2024 (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.
This is a randomized and controlled pilot study investigating the effects of intensive emotional stimulation with neurological waves (INES) on cognitive-motor functions in patients diagnosed with Vegetative State (VS) and Minimally Conscious State (MCS) following severe brain injury. The study aims to enroll at least 20 patients aged between 18 and 65 over 18 months. Patients will be recruited from the Neurorehabilitation Unit of Piedmont Hospital, IRCCS Centro Neurolesi Bonino Pulejo in Messina. The experimental group will receive multisensory stimulation using Neurowave (INES) for four weeks, five days a week, 45 minutes per session. The control group will undergo a traditional multisensory stimulation program.
Enrollment will use simple random sampling to minimize bias. Caregivers will provide biographical information, and both groups will be monitored using event-related potentials. Clinical scales will evaluate cognitive-motor outcomes at different time points. The study includes a one-month follow-up to assess long-term results. Data will be collected and exported for statistical analysis.
Detailed description
This study aims to investigate the cognitive-motor effects of emotionally significant advanced multisensory stimulation (INES) in patients diagnosed with Vegetative State (VS) and Minimally Conscious State (MCS) following severe acquired brain injury. Primary objectives include exploring short- and long-term efficacy through clinical-psychometric follow-up and examining potential correlations between neurophysiological and clinical-psychometric parameters as predictive indices of recovery.
The secondary objectives concern the implementation of highly specialized technological innovations in current clinical practice, and evaluating the rehabilitation effectiveness of advanced treatment with Neurological Waves.
Therefore, the study aims to develop models and protocols for multisensory rehabilitation stimulation and evaluate the synergies between different stimulation modalities and advanced cognitive electrophysiology techniques. Furthermore, the research aims to promote clinical investigations and systematic monitoring of post-acute patients, focusing on the quantitative analysis of EEG and Cognitive Evoked Potentials to unconventional sensory stimuli with emotionally significant content. The study also deepens the understanding of the role of the metabolic-nutritional state in the cognitive-motor recovery of patients with disorders of consciousness.
The present study is a randomized controlled pilot study, with an interventional, non-pharmacological, and single-center design.
Materials and methods:
The study will consecutively enroll at least 20 adult subjects diagnosed with disorders of consciousness at the Neurorehabilitation Unit of the Piedmont Hospital. Comprehensive multidimensional assessments will be conducted at baseline (T0), followed by an intensive one-month course of advanced multisensory training using Neurowave (INES) for the experimental group and conventional multisensory stimulation (ISES) for the control group. Evaluation at the end of each training cycle (T1) and a one-month follow-up (T2) will provide information on long-term results.
Inclusion criterion:
Participants must be between the ages of 18 and 65, with a Glasgow Coma Scale (GCS) score greater than 8 and a Cognitive Scale Level (LCF) between 1 and 3. Informed consent must be obtained from their legal guardian.
Exclusion criteria:
Exclusion criteria include individuals outside the specified age range, lack of legal guardian consent, anatomical alterations that prevent the correct placement of electrodes, and absence of neurophysiological responses in visual and auditory evoked potentials.
Registration start and end dates:
The study implementation period is expected to be from December 2023 to March 2025, with a total study duration of 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study adopts a Randomized Controlled Pilot design, an interventional, non-pharmacological, monocentric approach, aiming to explore cognitive-motor effects using advanced multisensory stimulation, the Neurowave system. Enrollment of at least 20 eligible subjects will occur consecutively at the Neurorehabilitation Unit of Piedmont Hospital. The study entails comprehensive baseline assessments (T0), succeeded by a one-month intensive cycle of advanced multisensory training. The experimental group will undergo Neurowave (INES) stimulation, while the control group will receive conventional multisensory stimulation (ISES - Intensive Sensorial Emotional Stimulation) without the advanced technological tool. Evaluations after each training cycle (T1) and a one-month follow-up (T2) will yield insights into short-term and long-term outcomes encompassing clinical-psychometric, neurophysiological, and metabolic-nutritional dimensions.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Intensive Neurowave Emotional Stimulation (INES)patients will receive Neurowave multisensory stimulation with concurrent event-related potential acquisition. This intensive training spans five days a week over four weeks, with each session lasting 45 minutes, summing up to 20 sessions. During each session, participants will encounter personalized visual and auditory stimuli. Neurowave treatment comprises an intensive intervention, presenting emotionally significant audio-visual content linked to the patient's life history. Within Neurowave use, visual stimuli will be complemented by primary auditory stimulation, involving exposure to emotionally charged everyday sounds. |
| Control group | Active comparator | Other: Intensive Sensorial Emotional Stimulation (ISES)Participants will receive primary auditory stimulation featuring familiar and emotionally evocative everyday sounds. This involves exposure to audio tapes and sounds related to their daily life, including voices of family and friends, snippets of favorite songs, and sounds associated with past work or leisure activities. The control group will undergo a program called Intensive Sensorial Emotional Stimulation (ISES), matching the frequency, intensity, and session duration of the experimental group but without Neurowave system utilization. Distinctively, the control group will not utilize Neurowave technology. Instead, they will follow a traditional rehabilitation approach incorporating paper materials, live photos, face-to-face interaction with the therapist, and the conventional listening of music tapes. This method aims to replicate an emotionally engaging environment, serving as a comparative reference to the experimental group's Neurowave-assisted experience. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 65 years.
- Glasgow Coma Scale (GCS) > 8.
- Level of Cognitive Scale (LCF) = 1-3.
- Consent is signed by the legal guardian.
Key exclusion criteria (4 listed)
- Age < 18 years or > 65 years.
- Lack of consent from the legal guardian.
- Patients with cranial anatomical alterations hindering proper electrode, headset, etc., placement.
- Patients showed no neurophysiological responses in visual evoked potentials (VEP) and no V wave in auditory evoked potentials (AEP).
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 |
|---|---|---|
| Intensive Neurowave Emotional Stimulation (INES)Also: Intensive Sensorial Emotional Stimulation (ISES)Patients will undergo Neurowave-assisted multisensory stimulation five days a week for four weeks, featuring emotionally significant audio-visual content tied to personal history. Control group participants will experience primary auditory stimulation through familiar sounds, following a traditional rehabilitation approach mimicking the experimental group's frequency and intensity but without Neurowave use. This allows for a meaningful comparison of the two groups' experiences. | Device | Experimental group |
| Intensive Sensorial Emotional Stimulation (ISES)Also: traditional rehabilitationThe Intensive Sensorial Emotional Stimulation (ISES) in the control group involves primary auditory stimulation with emotionally rich everyday sounds, including familiar voices, favorite songs, and sounds related to daily life and past activities. It mimics the experimental group's frequency and intensity, lasting 45 minutes per session, five days a week, for four weeks. Unlike the experimental group using Neurowave, the control group follows a traditional rehabilitation approach with paper materials, live photos, face-to-face interaction, and classic music tapes, facilitating a meaningful comparison between the two groups' experiences. | Other | Control group |
Primary outcome
Cognitive-Motor Functional Improvement Score
Time frame: clinical and psychometric scales will be administered to patients before starting sensory stimulation treatment (time T0), at the end of the stimulation cycle after 4 weeks (time T1), and one month after T1 (follow-up - Time T2).
The "Cognitive-Motor Functional Improvement Score" is a composite index designed to assess the enhancement of cognitive and motor functions in study participants. This score takes into account various clinical and psychometric measurements, including parameters such as the Glasgow Coma Scale (GCS), the Glasgow Outcome Scale (GOS), the Level of Cognitive Functioning (LCF), the Coma Recovery Scale-Revised (CRS-R), the Disability Rating Scale (DRS), and the Functional Communication Scale (FCS). The score reflects the progression in cognitive and motor abilities of patients before, during, and after the treatment, providing a comprehensive measure of the success of the rehabilitation intervention.
Examine Short and Long-Term Efficacy
Time frame: clinical and psychometric scales will be administered to patients before starting sensory stimulation treatment (time T0), at the end of the stimulation cycle after 4 weeks (time T1), and one month after T1 (follow-up - Time T2).
Examine the correlation between neurophysiological and clinical-psychometric parameters to monitor the long-term cognitive-motor effects of advanced multisensory training in individuals with disorders of consciousness, identifying potential predictive indices of recovery. Assessment Method: Clinical evaluations and psychometric tests focusing on cognitive-motor, neurophysiological, and metabolic-nutritional outcomes. Timing: Short-term assessments post-training (T1) and long-term follow-up one month after treatment completion (T2).
2 secondary outcomes
Study Neurophysiological and Clinical Correlations
Time frame: clinical and psychometric scales will be administered to patients before starting sensory stimulation treatment (time T0), at the end of the stimulation cycle after 4 weeks (time T1), and one month after T1 (follow-up - Time T2).
Explore the Role of Metabolic-Nutritional Status
Time frame: clinical and psychometric scales will be administered to patients before starting sensory stimulation treatment (time T0), at the end of the stimulation cycle after 4 weeks (time T1), and one month after T1 (follow-up - Time T2).
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 8 Apr 2026.
- Results publication: PubMed 28116238Sergent C, Faugeras F, Rohaut B, Perrin F, Valente M, Tallon-Baudry C, Cohen L, Naccache L. Multidimensional cognitive evaluation of patients with disorders of consciousness using EEG: A proof of concept study. Neuroimage Clin. 2016 Dec 10;13:455-469. doi: 10.1016/j.nicl.2016.12.004. eCollection 2017.
- Results publication: PubMed 27089287Padilla R, Domina A. Effectiveness of Sensory Stimulation to Improve Arousal and Alertness of People in a Coma or Persistent Vegetative State After Traumatic Brain Injury: A Systematic Review. Am J Occup Ther. 2016 May-Jun;70(3):7003180030p1-8. doi: 10.5014/ajot.2016.021022.
- Results publication: PubMed 12076410Lombardi F, Taricco M, De Tanti A, Telaro E, Liberati A. Sensory stimulation for brain injured individuals in coma or vegetative state. Cochrane Database Syst Rev. 2002;2002(2):CD001427. doi: 10.1002/14651858.CD001427.
- Results publication: PubMed 17925166Keller I, Hulsdunk A, Muller F. The influence of acoustic and tactile stimulation on vegetative parameters and EEG in persistent vegetative state. Funct Neurol. 2007 Jul-Sep;22(3):159-63.
- Individual participant dataSharing planned: No. We plan to make individual participant data (IPD) available to other researchers. This means that we intend to publish the databases, allowing access for other researchers to utilize the individualized data collected from each participant in our study. By doing so, we aim to contribute to the broader scientific community, fostering collaboration and enabling further exploration and analysis of the information gathered during our research.
Related trials for Disorders of Consciousness
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Recruiting
Heat and Mental Health - PART 2
Depressed Mood, Young Adults
Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
Enrolling by invitationObservational study
A Speaking-Valve-Based Decannulation Protoco for Patients With a Prolonged Disorders of Consciousness
Prolonged Disorders of Consciousness, Tracheostomy
Active, not recruiting
Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation
Atrial Fibrillation (Paroxysmal)
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.
Maria Grazia Maggio principal investigator
IRCCS Centro Neurolesi Bonino Pulejo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Neurowave Emotional Stimulation (INES) and Intensive Sensorial Emotional Stimulation (ISES) in people with Disorders of Consciousness, run by IRCCS Centro Neurolesi Bonino Pulejo 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 4 inclusion and 4 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 8 Apr 2026. 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?
Cognitive-Motor Functional Improvement Score (time frame: clinical and psychometric scales will be administered to patients before starting sensory stimulation treatment (time T0), at the end of the stimulation cycle after 4 weeks (time T1), and one month after T1 (follow-up - Time T2).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06204172, which also lists 4 linked publications.
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 8 Apr 2026.