Intensive Neurowave Emotional Stimulation (INES)

NCT06204172 | Completed DMC

• 1 other identifier: 02/2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Disorders of Consciousness

Keywords

Multisensory Stimulation; Acquired Brain Injury; Cognitive-Motor rehabilitation; Disorders of Consciousness; Metabolic-Nutritional Status

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  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

  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

  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).

Study Arms (2)

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.

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.

Other: Intensive Sensorial Emotional Stimulation (ISES)

Interventions

Intensive Neurowave Emotional Stimulation (INES) 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.

Also known as: Intensive Sensorial Emotional Stimulation (ISES)

Experimental group

Intensive Sensorial Emotional Stimulation (ISES) 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.

Also known as: traditional rehabilitation

Control group

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Centro Neurolesi Bonino Pulejo

Messina, Italy/Messina, 98124, Italy

Location

Related Publications (4)

• 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.

  PMID: 28116238 RESULT

• Padilla 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.

  PMID: 27089287 RESULT

• Lombardi 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.

  PMID: 12076410 RESULT

• Keller 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.

  PMID: 17925166 RESULT

MeSH Terms

Conditions

Consciousness Disorders; Brain Injuries

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Maria Grazia Maggio

  IRCCS Centro Neurolesi Bonino Pulejo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 12, 2024
• Study Start: December 14, 2023
• Primary Completion: December 14, 2024
• Study Completion: March 30, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)