Intensive Neurowave Emotional Stimulation (INES)

Disorders of Consciousness Clinical Trial

— INES_ABI  

Official title:

Intensive Neurowave Emotional Stimulation (INES): A Pioneering RCT Investigating Cognitive-Motor Impact in Consciousness Disorders Post Severe Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06204172
• Other study ID #: 02/2023
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2023
• Est. completion date: September 15, 2025

Study information

• Verified date: January 2024
• Source: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Contact: Maria Grazia Maggio, PsyD, PhD
• Phone: +30-09060128840
• Email: mariagrazia.maggio[@]irccsme.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 15, 2025
• Est. primary completion date: December 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorders of Consciousness

Intervention

Device:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Italy	IRCCS Centro Neurolesi Bonino Pulejo	Messina	Italy/Messina

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Centro Neurolesi "Bonino-Pulejo"

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. — View Citation

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: 10.50 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	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.	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	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.	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).