Prognostic Factors to Regain Consciousness

NCT04445649 | Recruiting

• 1 other identifier: DOC-OUT
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to identify factors that predict the medium and long-term outcome of patients with disorders of consciousness (DOC) undergoing early neurological rehabilitation. In this prospective, observational study, 130 DOC patients are going to be included (36 months). At study entry, different routine data, disease severity and functional status are documented for each patient. In addition, MRI, EEG and evoked potentials are measured within the first week. The level of consciousness is recorded with the Coma-Recovery-Scale-Revised and serves as the primary outcome parameter. Complications, comorbidities, functional status and leve of consciousness are assessed weekly. After eight weeks, the measurement of the MRI, the EEG and the evoked potentials are repeated. After 3, 6 and 12 months, the Glasgow Outcome Scale-Revised is used to followed up the current status of the patients.

Conditions

Neurologic Disorder; Disorder of Consciousness; Traumatic Brain Injury; Stroke; Hypoxic-Ischemic Encephalopathy

Keywords

Neurological rehabilitation; Prognosis; Outcome; Level of consciousness

Outcome Measures

Primary Outcomes (1)

• Changed functional status

  Functional status is measured with Early Rehabilitation Barthel Index (ERBI; Range: -325 to 100; higher scores mean a better outcome) weekly.

  8 weeks

Secondary Outcomes (2)

• Changed level of consciousness

  8 weeks

• Duration until consciousness is regained

  up to 8 weeks

Study Arms (1)

ICU patients

Patients with impaired consciousness admitted to intensive care unit after severe brain injury

Diagnostic Test: Coma-Recovery-Scale-Revised (CRS-R)

Interventions

Coma-Recovery-Scale-Revised (CRS-R) DIAGNOSTIC_TEST

CRS-R assessments (15 minutes) are repeated weekly after study entry

ICU patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing neurological early rehabilitation with impaired consciousness and admitted to intensive care unit

You may qualify if:

• early neurological rehabilitation (phase B)
• stroke, traumatic brain injury, hypoxic-ischemic encephalopathy
• disorder of consciousness (coma, UWS, MCS)
• at minimum two weeks after disease onset
• admission to intensive care unit
• written consent from the patient's legal representative

You may not qualify if:

• insufficient cardiorespiratory stability
• fractures or severe infratentorial brain injuries leading to impaired auditory evoked - potentials
• previous brain damage
• mental disorders (dementia, depression)
• colonization with multi-resistant pathogens
• MRI contraindications
• claustrophobia
• weight \> 120 kg

Sponsors & Collaborators

• BDH-Klinik Hessisch Oldendorf: lead

Study Sites (1)

BDH-Clinic Hessisch Oldendorf

Hessisch Oldendorf, 31840, Germany

RECRUITING

Related Publications (5)

• Lucca LF, Lofaro D, Pignolo L, Leto E, Ursino M, Cortese MD, Conforti D, Tonin P, Cerasa A. Outcome prediction in disorders of consciousness: the role of coma recovery scale revised. BMC Neurol. 2019 Apr 18;19(1):68. doi: 10.1186/s12883-019-1293-7.

  PMID: 30999877 BACKGROUND

• Portaccio E, Morrocchesi A, Romoli AM, Hakiki B, Taglioli MP, Lippi E, Di Renzone M, Grippo A, Macchi C; Intensive Rehabilitation Unit Study Group of the IRCCS Don Gnocchi Foundation, Italy. Improvement on the Coma Recovery Scale-Revised During the First Four Weeks of Hospital Stay Predicts Outcome at Discharge in Intensive Rehabilitation After Severe Brain Injury. Arch Phys Med Rehabil. 2018 May;99(5):914-919. doi: 10.1016/j.apmr.2018.01.015. Epub 2018 Feb 8.

  PMID: 29428346 BACKGROUND

• Portaccio E, Morrocchesi A, Romoli AM, Hakiki B, Taglioli MP, Lippi E, Di Renzone M, Grippo A, Macchi C. Score on Coma Recovery Scale-Revised at admission predicts outcome at discharge in intensive rehabilitation after severe brain injury. Brain Inj. 2018;32(6):730-734. doi: 10.1080/02699052.2018.1440420. Epub 2018 Feb 26.

  PMID: 29482376 BACKGROUND

• Estraneo A, Moretta P, Loreto V, Lanzillo B, Cozzolino A, Saltalamacchia A, Lullo F, Santoro L, Trojano L. Predictors of recovery of responsiveness in prolonged anoxic vegetative state. Neurology. 2013 Jan 29;80(5):464-70. doi: 10.1212/WNL.0b013e31827f0f31. Epub 2013 Jan 9.

  PMID: 23303855 BACKGROUND

• Estraneo A, Moretta P, Loreto V, Lanzillo B, Santoro L, Trojano L. Late recovery after traumatic, anoxic, or hemorrhagic long-lasting vegetative state. Neurology. 2010 Jul 20;75(3):239-45. doi: 10.1212/WNL.0b013e3181e8e8cc. Epub 2010 Jun 16.

  PMID: 20554941 BACKGROUND

MeSH Terms

Conditions

Nervous System Diseases; Consciousness Disorders; Brain Injuries, Traumatic; Stroke; Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Hypoxia, Brain; Hypoxia; Signs and Symptoms, Respiratory

Study Officials

• Jens D Rollnik, MD

  BDH-Clinic Hessisch Oldendorf

  STUDY DIRECTOR

• Melanie Boltzmann, PhD

  BDH-Clinic Hessisch Oldendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie Boltzmann, PhD

CONTACT

0049 5152 781 256; m.boltzmann@bdh-klinik-hessisch.oldendorf

Simone B Schmidt, PhD

CONTACT

0049 5152 781 215; si.schmidt@bdh-klinik-hessisch.oldendorf

Study Design

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

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 24, 2020
• Study Start: June 15, 2020
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Period of availability begins when results are published, at the earliest in Dec 2023
• Access Criteria: IPD can be obtained from the principal investigator upon reasonable request.

Locations

DE (1)