Brain InjuryPhase 1/2NCT02100592
Early Verticalization in neuroICU With ERIGO: a Safety and Feasibility Study
A Phase 1/2 study testing Early rehabilitation treatment on Erigo Hocoma in people with Brain Injury, run by Ospedale Generale Di Zona Moriggia-Pelascini.
Trial summary
Severe brain injuries induce alteration of state of consciousness. These functional limitations can be significantly alleviated by treatment neurorehabilitation, particularly if this is established early. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Injury
- What is being tested?
- Early rehabilitation treatment on Erigo Hocoma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Mar 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient / a severe acquired brain injury occurred 3 to 30 days prior to enrollment
- Age between 18 and 75 years
- Glasgow Coma Scale ≤ 8 at entrance in ICUs
- Adequate respiratory exchange with PaO2/FiO2 ≥ 250
- Absence of sedation increased
Who cannot join
- Major chest trauma with multiple rib fractures and / or pneumothorax
- Presence of fractures, vascular lesions, skin lesions with loss of substance in the abdomen, pelvis or lower limb
- Cardiovascular instability despite support with amines
- Intracranial pressure (ICP)> 25 mm / Hg
- Cerebral Perfusion Pressure (PPC) <60 mm / Hg
- Severe kidney failure requiring replacement therapy
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- Decompensated liver disease
- Hematocrit value of ≤ 30%
- Body weight> 135 kg or height> 210 cm
- Deep vein thrombosis
About this study
Severe brain injuries induce alteration of state of consciousness. These functional limitations can be significantly alleviated by treatment neurorehabilitation, particularly if this is established early. It has been shown that treatment of vertical integration in patients in a vegetative state or minimally conscious state can improve the level of supervision and positive influence on rehabilitation. Therefore, there are sufficient indications that anticipate the treatment of vertical integration, since the phase of hospitalization in ICUs, may improve the functional outcome of the patient.
Read the detailed description
Early verticalization and stepping with the equipment Hocoma Erigo, during monitoring of vital parameters. The device Erigo is already CE marked and, for the purposes of the study, will be used in accordance with the intended use of the same mark (after-market clinical investigation).
- Conditions
- Brain Injury
- Being tested
- Early rehabilitation treatment on Erigo Hocoma
- Keywords
- brain injury, coma, intensive care, early rehabilitation
- Medical subject headings
- Brain Injuries, Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early rehabilitation treatment on Erigo HocomaOther
5 weekly sessions of erigo for three weeks. Expected tilt angle up to 60 °
Early rehabilitation treatment on Erigo HocomaOther
Early verticalization treatment with Erigo Hocoma, a tilt table with stepping system
| Study group | Role | What they receive |
|---|---|---|
| Erigo treated | Experimental | Early rehabilitation treatment on Erigo Hocoma, a tilt table with integrated stepping device within 3 - 30 days from injury Receives: Other: Early rehabilitation treatment on Erigo Hocoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events during verticalization
It is a composite outcome, assessing the occurence of at least one of the following conditions (component outcomes):
Heart rate <40 bpm or> 150 bpm; Mean arterial pressure <70 mmHg; Arterial oxygen saturation <90%; Onset of ECG anomalies; Traumatic dislodgement of a device;
Measured: 21 days: from T1 (first session) to T15 (last session)
Secondary outcomes (1)
Changes of hemodynamic parameters
Changes of hemodynamic parameters during each session and from T1 to T15; assessed parameters are:
stroke volume; peripheral resistances; mean arterial pressure; cerebral perfusion pressure.
Measured: 21 days: from T1 (first session) to T15 (last session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study startOct 2012
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Frazzitta, MD, Study chair, Ospedale generale di zona 'Moriggia Pelascini'Roberto Valsecchi, MD, Principal investigator, Ospedale generale di zona 'Moriggia Pelascini'Leopold Saltuari, MD, Principal investigator, LDK HochzirlLuca Sebastianelli, MD, Principal investigator, Ospedale generale di zona 'Moriggia Pelascini'
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100592
- Sponsor's protocol ID
- ERIGO-1
- Status last verified
- Mar 2014
- First submitted
- 24 Mar 2014
- Last updated
- 1 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Verticalization in neuroICU With ERIGO: a Safety and Feasibility Study
- ClinicalTrials.gov ID
- NCT02100592
- Acronym / sponsor ID
- ERIGO-1
- Conditions
- Brain Injury
- Keywords
- brain injury, coma, intensive care, early rehabilitation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 1 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Severe brain injuries induce alteration of state of consciousness. These functional limitations can be significantly alleviated by treatment neurorehabilitation, particularly if this is established early. It has been shown that treatment of vertical integration in patients in a vegetative state or minimally conscious state can improve the level of supervision and positive influence on rehabilitation. Therefore, there are sufficient indications that anticipate the treatment of vertical integration, since the phase of hospitalization in ICUs, may improve the functional outcome of the patient.
Detailed description
Early verticalization and stepping with the equipment Hocoma Erigo, during monitoring of vital parameters. The device Erigo is already CE marked and, for the purposes of the study, will be used in accordance with the intended use of the same mark (after-market clinical investigation).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erigo treated | Experimental | Other: Early rehabilitation treatment on Erigo HocomaEarly rehabilitation treatment on Erigo Hocoma, a tilt table with integrated stepping device within 3 - 30 days from injury |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient / a severe acquired brain injury occurred 3 to 30 days prior to enrollment
- Age between 18 and 75 years
- Glasgow Coma Scale ≤ 8 at entrance in ICUs
- Adequate respiratory exchange with PaO2/FiO2 ≥ 250
- Absence of sedation increased
Key exclusion criteria (10 listed)
- Major chest trauma with multiple rib fractures and / or pneumothorax
- Presence of fractures, vascular lesions, skin lesions with loss of substance in the abdomen, pelvis or lower limb
- Cardiovascular instability despite support with amines
- Intracranial pressure (ICP)> 25 mm / Hg
- Cerebral Perfusion Pressure (PPC) <60 mm / Hg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early rehabilitation treatment on Erigo Hocoma5 weekly sessions of erigo for three weeks. Expected tilt angle up to 60 ° | Other | Erigo treated |
| Early rehabilitation treatment on Erigo HocomaEarly verticalization treatment with Erigo Hocoma, a tilt table with stepping system | Other | Erigo treated |
Primary outcome
Adverse events during verticalization
Time frame: 21 days: from T1 (first session) to T15 (last session)
It is a composite outcome, assessing the occurence of at least one of the following conditions (component outcomes): Heart rate <40 bpm or> 150 bpm; Mean arterial pressure <70 mmHg; Arterial oxygen saturation <90%; Onset of ECG anomalies; Traumatic dislodgement of a device;
1 secondary outcome
Changes of hemodynamic parameters
Time frame: 21 days: from T1 (first session) to T15 (last session)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Frazzitta, MD study chair
Ospedale generale di zona 'Moriggia Pelascini'
Roberto Valsecchi, MD principal investigator
Ospedale generale di zona 'Moriggia Pelascini'
Leopold Saltuari, MD principal investigator
LDK Hochzirl
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Early rehabilitation treatment on Erigo Hocoma in people with Brain Injury, run by Ospedale Generale Di Zona Moriggia-Pelascini.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events during verticalization (time frame: 21 days: from T1 (first session) to T15 (last session)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2014.