Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204172
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-12-15
Brief Title:
Intensive Neurowave Emotional Stimulation INES
Sponsor:
IRCCS Centro Neurolesi Bonino-Pulejo
Organization:
IRCCS Centro Neurolesi Bonino-Pulejo
Study Overview
Official Title:
Intensive Neurowave Emotional Stimulation INES A Pioneering RCT Investigating Cognitive-Motor Impact in Consciousness Disorders Post Severe Brain Injury
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INES_ABI
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None