Peripheral Nerve Stimulation for Prognostic and Diagnostic Biomarker Identification in Disorders of Consciousness

NCT06845800 | Completed

• 1 other identifier: TUNEBEAM_MICRODOC
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to integrate anamnestic, clinical, and innovative neurophysiological data to assess their impact on the diagnosis and prognosis of patients with Disorders of Consciousness. The main questions it aims to answer are:

• Is it possible to identify biomarkers with high diagnostic relevance for distinguishing subcategories of patients with Disorders of Consciousness?
• Can biomarkers with potential medium- and long-term prognostic value be identified for each category of patients with Disorders of Consciousness? Participants will undergo an EEG examination during near-nerve stimulation of the median nerve. Clinical and anamnestic data will also be recorded and collected at follow-up.

Conditions

Disorders of Consciousness Due to Severe Brain Injury

Keywords

Electroencephalography; Near-Nerve Stimulation; Prognosis; Diagnosis; Neurorehabilitation; Disorder of Consciousness

Outcome Measures

Primary Outcomes (2)

• Identification of Neurophysiological Diagnostic Biomarkers in Disorders of Consciousness

  Quantification of the Agreement Between Newly Proposed Neurophysiological Markers From Near-Nerve Stimulation Examinations and Disorders of Consciousness Classification Based on the Coma Recovery Scale-Revised (UWS, MCS-, MCS+)

  From enrollment to the baseline experimental session (within 7 days from enrollment)

• Identification of Neurophysiological Prognostic Biomarkers in Disorders of Consciousness

  Quantification of Prognostic Prediction Accuracy of Newly Proposed Neurophysiological Markers From Near-Nerve Stimulation in Classifying Disorders of Consciousness Based on the Coma Recovery Scale - Revised (UWS, MCS-, MCS+, EMCS)

  From enrollment to the end of follow up at 6-months from baseline assessment

Study Arms (1)

Patients with Disorders of Consciousness admitted to the Intensive Rehabilitation Unit

Patients admitted with a Disorder of Consciousness to the Intensive Rehabilitation Unit (IRU) of Fondazione Don Carlo Gnocchi (Florence). * Age ≥ 18 years, both sexes; * Severe Acquired Brain Injury (ABI), regardless of etiology; * Patients with a severe alteration of consciousness due to severe ABI of various etiologies, including Cardiac Arrest, Traumatic Brain Injury, Cerebral Ischemia, or Hemorrhage; * Signed informed consent provided by a family member, caregiver, or legal guardian.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were admitted with a Disorder of Consciousness to the Intensive Rehabilitation Unit (IRU) of Fondazione Don Carlo Gnocchi (Florence).

You may qualify if:

• Age \> 18 years, both sexes;
• Severe acquired brain injury (regardless of etiology);
• Patients with severe alteration of consciousness state due to severe acquired brain injury of various etiologies (Cardiac Arrest, Traumatic Brain Injury, Cerebral Ischemia or Hemorrhage);
• Informed consent signature by family member/caregiver/legal guardian.

You may not qualify if:

• Time since the acute event greater than 3 months;
• Previous neurological diseases;
• Previous acute brain injuries, psychiatric disorders, neurodegenerative diseases, neoplasms, severe systemic diseases;
• Modified Barthel Index pre-event \< 50;
• Unstable medical conditions.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Scuola Superiore Sant'Anna Pisa: collaborator

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi

Florence, FI, 50143, Italy

Location

Related Publications (3)

• Vallbo AB. Microneurography: how it started and how it works. J Neurophysiol. 2018 Sep 1;120(3):1415-1427. doi: 10.1152/jn.00933.2017. Epub 2018 Jun 20.

  PMID: 29924706 BACKGROUND

• Mano T, Iwase S, Toma S. Microneurography as a tool in clinical neurophysiology to investigate peripheral neural traffic in humans. Clin Neurophysiol. 2006 Nov;117(11):2357-84. doi: 10.1016/j.clinph.2006.06.002. Epub 2006 Aug 10.

  PMID: 16904937 BACKGROUND

• Hakiki B, Donnini I, Romoli AM, Draghi F, Maccanti D, Grippo A, Scarpino M, Maiorelli A, Sterpu R, Atzori T, Mannini A, Campagnini S, Bagnoli S, Ingannato A, Nacmias B, De Bellis F, Estraneo A, Carli V, Pasqualone E, Comanducci A, Navarro J, Carrozza MC, Macchi C, Cecchi F. Clinical, Neurophysiological, and Genetic Predictors of Recovery in Patients With Severe Acquired Brain Injuries (PRABI): A Study Protocol for a Longitudinal Observational Study. Front Neurol. 2022 Feb 28;13:711312. doi: 10.3389/fneur.2022.711312. eCollection 2022.

  PMID: 35295839 BACKGROUND

MeSH Terms

Conditions

Disease; Consciousness Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 25, 2025
• Study Start: July 21, 2022
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Upon publication of results
• Access Criteria: Data and code will be available for research purposes upon request to authors.

Locations

IT (1)