Status:
RECRUITING
Intensive Neurowave Emotional Stimulation (INES)
Lead Sponsor:
IRCCS Centro Neurolesi Bonino Pulejo
Conditions:
Disorders of Consciousness
Eligibility:
All Genders
16-65 years
Phase:
NA
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 Vege...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06204172
Start Date
December 14 2023
End Date
September 15 2025
Last Update
January 12 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
IRCCS Centro Neurolesi Bonino Pulejo
Messina, Italy/Messina, Italy, 98124