Actively Recruiting
Behavioural and Physiological Responses to Tickling in Patients With Disorders of Consciousness
Led by Anna Estraneo · Updated on 2025-04-23
45
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether tickling can have a short-term effect on patients with Disorders of Consciousness (DoC) caused by Severe Acquired Brain Injury. The study compares responses to tickling with responses to neutral touch that does not cause tickling, aiming to understand patient responsiveness. This observational research includes behavioral and physiological monitoring to explore neural activity during these stimulations. During the experimental session, patients will undergo assessments using the Coma Recovery Scale-Revised (CRS-R) and the Nociception Coma Scale-Revised (NCS-R) to ensure responses are not influenced by pain. Non-invasive brain monitoring with fNIRS and EEG via SedLine will be used. Patients will receive manual tickling and neutral touch on specified body areas in a randomized order, with recordings before, during, and after the stimulations. Participants will be monitored for facial expressions, vocalizations, body movements, and emotional changes during the session, which lasts about one hour and fifteen minutes. The study measures behavioral responses from video analysis, brain blood flow changes via fNIRS, and cortical EEG activity. These outcomes will help assess responsiveness in DoC patients, with careful safety monitoring throughout the single-session protocol.
CONDITIONS
Brief Title
Tickle Stimulation in Disorders of Consciousness (DoC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of disorders of consciousness (DoC) based on the CRS-R scale
- Age 18 years or older
- Time since the brain injury event is 28 days or more
You will not qualify if you...
- Having a large craniectomy that may interfere with fNIRS recording
- Unstable clinical conditions such as respiratory failure, fever, or status epilepticus
- Fractures, paralysis, injuries, or muscular dystrophy that prevent stimulation of feet, armpits, ribs, or forehead
- Lack of informed consent from the legal representative
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 30 minutes
Participants undergo the Coma Recovery Scale-Revised (CRS-R) and the Nociception Coma Scale-Revised (NCS-R) to assess their baseline behavioral and nociceptive responses before stimulation.
1 baseline visit (in-person)
Duration - Approximately 45 minutes
Participants receive manual tickle and neutral stimulation on specific body areas while wearing non-invasive brain monitoring devices (fNIRS and SedLine EEG). Behavioral responses are recorded via video for later analysis.
1 experimental session (in-person)
Trial Site Locations
Total: 2 locations
1
Coma Science Group - University of Liege
Liège, Belgium, Belgium, 4000
Completed
2
Fondazione Don Gnocchi
Sant'Angelo dei Lombardi, Avellino, Italy, 83054
Actively Recruiting
Research Team
S
Simona Abagnale, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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