Investigating tickle stimulation effects in patients with Disorders of Consciousness
Behavioural and Physiological Responses to Tickling in Patients With Disorders of Consciousness
This study is testing if tickling can help patients with severe brain injuries respond better compared to regular touch.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus Academic / other |
| Locations | 2 sites (Liège, Belgium and 1 other locations) |
| Trial ID | NCT06922162 on ClinicalTrials.gov |
What this trial studies
This project aims to explore the short-term effects of tickle stimulation on the responsiveness of patients with Disorders of Consciousness resulting from severe acquired brain injury. Patients will undergo behavioral and neurophysiological evaluations to ensure that responses are not influenced by pain. The study will compare the effects of tickling in specific body areas with neutral tactile stimulation. Each stimulation will be carefully monitored and recorded for analysis of facial expressions to assess differences in responsiveness.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with Disorders of Consciousness at least 28 days post-injury.
Not a fit: Patients with unstable clinical conditions or physical limitations that prevent proper stimulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of responsiveness in patients with Disorders of Consciousness and potentially improve their care.
How similar studies have performed: While the approach of using tickle stimulation is novel, similar studies exploring sensory stimulation in patients with Disorders of Consciousness have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of disorders of consciousness (DoC) based on the CRS-R scale; * Age ≥18 years; * Time since the event ≥ 28 days Exclusion Criteria: * Large craniectomy that may interfere with fNIRS recording; Unstable clinical conditions (e.g., respiratory failure, fever, status epilepticus, etc.); * Fractures, paralysis, injuries, or muscular dystrophy that prevent proper stimulation of the aforementioned body parts; * Lack of informed consent from the legal representative.
Where this trial is running
Liège, Belgium and 1 other locations
- Coma Science Group - University of Liege — Liège, Belgium, Belgium (Completed)
- Fondazione Don Gnocchi — Sant'Angelo dei Lombardi, Avellino, Italy (Recruiting)
Study contacts
- Principal investigator: Anna Estraneo, MD — Fondazione Don Gnocchi
- Study coordinator: Simona Abagnale, PhD
- Email: sabagnale@dongnocchi.it
- Phone: +393487520258
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.