Intensive Neurowave Emotional Stimulation (INES)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-14

Study Completion Date

2025-09-15

Brief Summary

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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.

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Detailed Description

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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

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Disorders of Consciousness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

To minimize the effect of selection bias (or even selection distortion), subject enrollment in the respective study arms (experimental or control) will be carried out through simple randomization sampling, i.e., randomly. Randomization is achieved by extracting numbers from a list, referred to as the 'sampling list,' which includes all individuals in the study population

Study Groups

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Experimental group

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.

Group Type EXPERIMENTAL

Intensive Neurowave Emotional Stimulation (INES)

Intervention Type DEVICE

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.

Control group

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.

Group Type ACTIVE_COMPARATOR

Intensive Sensorial Emotional Stimulation (ISES)

Intervention Type OTHER

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.

Interventions

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Intensive Neurowave Emotional Stimulation (INES)

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.

Intervention Type DEVICE

Intensive Sensorial Emotional Stimulation (ISES)

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.

Intervention Type OTHER

Other Intervention Names

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Intensive Sensorial Emotional Stimulation (ISES) traditional rehabilitation

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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).

Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No