NCT05802524

Brief Summary

Identify potential markers of recovery through event-related potentials (ERPs) in the evolution of altered consciousness with potential ability to discriminate between different conditions of altered state of consciousness. Identify potential markers with prognostic value, in order to identify personalized and specific intensive rehabilitation paths based on the outcome indexes obtained.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
Last Updated

April 6, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

March 15, 2023

Last Update Submit

March 27, 2023

Conditions

Consciousness DisorderCognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • Event-related evoked potentials(ERPs)

    Event-related evoked potentials(ERPs) are variations of the electric potential deriving from a visual, somesthetic or auditory stimulus.

    24 months

Interventions

Neurowave GroupDIAGNOSTIC_TEST

Neurosensory stimulation will consist in the administration of pairs of stimuli consisting of emotionally significant images and sounds in the personal life history (two rare stimuli) alternating with neutral images and sounds devoid of emotional significance (two "distracting" stimuli

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Departments of Serious Acquired Brain Injuries

You may qualify if:

  • Glasgow Coma Scale (GCS) \> 8;
  • Level of Cognitive Scale (LCF) = 1-3;
  • Signature of the consent from the family member and/or guardian.

You may not qualify if:

  • Failure to sign the consent of the family member and/or legal guardian;
  • Patients with cranial anatomical alterations that do not allow the correct assembly of the electrodes, caps, etc.;
  • Patients with absence of neurophysiological responses in visual evoked potentials (VEP) and with absence of peripheral waves (I-II wave) to acoustic potentials (PEA).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Centro Neurolesi "Bonino-Pulejo"

Messina, 98124, Italy

Location

MeSH Terms

Conditions

Consciousness DisordersCognitive Dysfunction

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersCognition Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2023

First Posted

April 6, 2023

Study Start

June 14, 2020

Primary Completion

June 1, 2022

Study Completion

June 14, 2022

Last Updated

April 6, 2023

Record last verified: 2023-03

Locations

IT(1)