Intensive Neurowave Emotional Stimulation (INES) — INES_ABI  

Disorders of Consciousness Clinical Trial

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

Status Recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorders of Consciousness

• NCT number: NCT06204172
• Study type: Interventional
• Source: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Contact: Maria Grazia Maggio, PsyD, PhD
• Phone: +30-09060128840
• Email: mariagrazia.maggio@irccsme.it
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2023
• Completion date: September 15, 2025