Comparing pain responses in non-communicative patients with personalized stimuli
Nociception Coma Scale-Revised Recorded After Personalized Stimulus May Improve Assessment of Pain Responses in Non-communicative Patients With Disorders of Consciousness. An International Multicentric Study
This study is testing if personalized pain responses can help better understand and manage pain in non-communicative patients with severe brain injuries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 33 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | I.R.C.C.S. Fondazione Santa Lucia Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06012357 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of the Nociception Coma Scale-Revised (NCS-R) in assessing pain responses in non-communicative patients with disorders of consciousness (DoC). It compares standard painful stimuli applied to the fingernail bed with personalized painful stimuli tailored to individual patients. The study seeks to establish correlations between NCS-R scores and the Coma Recovery Scale-Revised (CRS-R) to enhance understanding and management of pain in these patients. By integrating clinical measures and behavioral observations, the research aims to improve treatment and rehabilitation outcomes for individuals with severe acquired brain injuries.
Who should consider this trial
Good fit: Ideal candidates include individuals with severe acquired brain injury and a diagnosis of disorders of consciousness, such as vegetative state or minimally conscious state.
Not a fit: Patients with a history of previous brain injury, neurological or psychiatric disorders, or those with substance abuse issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management and rehabilitation strategies for patients with disorders of consciousness.
How similar studies have performed: While the approach of using personalized stimuli in pain assessment is innovative, similar studies have not been widely reported, indicating this may be a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * severe acquired brain injury (sABI), * clinical history and neuroimaging (brain CT and/or MRI) and fulfilling the criteria proposed for the sABI diagnosis: * Glasgow Coma Scale (GCS) score ≤ 8 within 24 hours after injury, * diagnosis of disorders of consciousness (DoC), (VS/UWS or MCS), according to the Coma Recovery Scale-Revised (CRS-R), * interval from the acute event of at least 3 months. Exclusion Criteria: * history of previous brain injury, * neurological or psychiatric disorders, * alcohol or illicit drug abuse and concomitant spinal cord injury
Where this trial is running
Rome
- Rita Formisano — Rome, Italy (Recruiting)
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.