Intensive emotional stimulation for patients with disorders of consciousness
Intensive Neurowave Emotional Stimulation (INES): A Pioneering RCT Investigating Cognitive-Motor Impact in Consciousness Disorders Post Severe Brain Injury
This study is testing a new emotional stimulation treatment to see if it can help improve brain function in patients with severe brain injuries who are in a vegetative or minimally conscious state.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | IRCCS Centro Neurolesi Bonino Pulejo Academic / other |
| Locations | 1 site (Messina, Italy/Messina) |
| Trial ID | NCT06204172 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of Intensive Neurowave Emotional Stimulation (INES) on cognitive-motor functions in patients diagnosed with Vegetative State (VS) and Minimally Conscious State (MCS) due to severe brain injury. It aims to enroll at least 20 patients aged 18 to 65 over 18 months, comparing an experimental group receiving INES with a control group undergoing traditional multisensory stimulation. The study will utilize random sampling and monitor outcomes using clinical scales and neurophysiological assessments to evaluate the efficacy of the intervention. Additionally, it seeks to explore the relationship between neurophysiological responses and cognitive recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a Glasgow Coma Scale score greater than 8 and a Level of Cognitive Scale score between 1 and 3.
Not a fit: Patients under 18 or over 65, those without legal guardian consent, or those with cranial anatomical alterations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance cognitive-motor recovery in patients with severe brain injuries.
How similar studies have performed: While similar approaches have been explored, this specific method of using Intensive Neurowave Emotional Stimulation is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Messina, Italy/Messina
- IRCCS Centro Neurolesi Bonino Pulejo — Messina, Italy/Messina, Italy (Recruiting)
Study contacts
- Principal investigator: Maria Grazia Maggio — IRCCS Centro Neurolesi Bonino Pulejo
- Study coordinator: Maria Grazia Maggio, PsyD, PhD
- Email: mariagrazia.maggio@irccsme.it
- Phone: +30-09060128840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.