Consciousness DisordersNCT02714491
Effects of Auditory Stimulation During Verticalization With Erigo in Patients With Disorder of Consciousness
A study testing Erigo + Music, Erigo + Metronome and Erigo + Silence in people with Consciousness Disorders, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
Trial summary
Aim of the study is to define if the auditory stimulation during stepping verticalization sessions with "Erigo" is able to modify the cerebral electric activity or improve consciousness in patients affected by vegetative state or minimally conscious state. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Consciousness Disorders
- What is being tested?
- Erigo + Music, Erigo + Metronome and Erigo + Silence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2015to Jun 2017
- Phase
- Interventional
- 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
- Vegetative State or Minimally Conscious State diagnosis
- >3 months from acute brain injury
Who cannot join
- No clinical stability
- Sepsis
- Orthopaedic contraindications for verticalization
- Deep Vein Thrombosis
- weight >130 Kg
- height >210 cm
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale Generale di Zona Moriggia Pelascini
Gravedona Ed Uniti, CO, 22015
Giuseppe Frazzitta, MD, +39034492111, frazzittag62@gmail.com
About this study
Aim of the study is to define if the auditory stimulation during stepping verticalization sessions with "Erigo" is able to modify the cerebral electric activity or improve consciousness in patients affected by vegetative state or minimally conscious state.
- Conditions
- Consciousness Disorders
- Being tested
- Erigo + Music, Erigo + Metronome, Erigo + Silence
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erigo + MusicOther
The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with "Erigo" (3/week for 5 consecutive weeks) and musical stimulation.
Erigo + MetronomeOther
The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with "Erigo" (3/week for 5 consecutive weeks) and metronome stimulation.
Erigo + SilenceOther
The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with "Erigo" (3/week for 5 consecutive weeks), without auditory stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Music | Active comparator | Erigo + Music: During each stepping verticalization session the patient receives auditory stimulation (earphones) with previously preferred music Receives: Other: Erigo + Music |
| Metronome | Active comparator | Erigo + Metronome: During each stepping verticalization session the patient receives auditory stimulation (earphones) with a metronome (rhythmic with the stepping movement) Receives: Other: Erigo + Metronome |
| Silence | Active comparator | Erigo + Silence: During each stepping verticalization session the patient does note receive any auditory stimulation. Receives: Other: Erigo + Silence |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Coma Recovery Scale revised score
Measured: 0 and 35 days
Secondary outcomes (4)
change in Levels of Cognitive Functioning score
Measured: 0 and 35 days
change in Disability Rating Scale score
Measured: 0 and 35 days
change in quantitative EEG parameters
Measured: 0 and 35 days
change in Glasgow Coma Scale score
Measured: 0 and 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startJun 2015
- Primary completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Consciousness DisordersStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714491
- Sponsor's protocol ID
- Erigo.stim
- Status last verified
- Sep 2016
- First submitted
- 10 Mar 2016
- Last updated
- 30 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Auditory Stimulation During Verticalization With Erigo in Patients With Disorder of Consciousness
- ClinicalTrials.gov ID
- NCT02714491
- Acronym / sponsor ID
- Erigo.stim
- Conditions
- Consciousness Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2017 (estimated)
- First posted
- 21 Mar 2016 (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.
Aim of the study is to define if the auditory stimulation during stepping verticalization sessions with "Erigo" is able to modify the cerebral electric activity or improve consciousness in patients affected by vegetative state or minimally conscious state.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Music | Active comparator | Other: Erigo + MusicErigo + Music: During each stepping verticalization session the patient receives auditory stimulation (earphones) with previously preferred music |
| Metronome | Active comparator | Other: Erigo + MetronomeErigo + Metronome: During each stepping verticalization session the patient receives auditory stimulation (earphones) with a metronome (rhythmic with the stepping movement) |
| Silence | Active comparator | Other: Erigo + SilenceErigo + Silence: During each stepping verticalization session the patient does note receive any auditory stimulation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Vegetative State or Minimally Conscious State diagnosis
- >3 months from acute brain injury
Key exclusion criteria (6 listed)
- No clinical stability
- Sepsis
- Orthopaedic contraindications for verticalization
- Deep Vein Thrombosis
- weight >130 Kg
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 |
|---|---|---|
| Erigo + MusicThe patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with "Erigo" (3/week for 5 consecutive weeks) and musical stimulation. | Other | Music |
| Erigo + MetronomeThe patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with "Erigo" (3/week for 5 consecutive weeks) and metronome stimulation. | Other | Metronome |
| Erigo + SilenceThe patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with "Erigo" (3/week for 5 consecutive weeks), without auditory stimulation. | Other | Silence |
Primary outcome
change in Coma Recovery Scale revised score
Time frame: 0 and 35 days
4 secondary outcomes
change in Levels of Cognitive Functioning score
Time frame: 0 and 35 days
change in Disability Rating Scale score
Time frame: 0 and 35 days
change in quantitative EEG parameters
Time frame: 0 and 35 days
change in Glasgow Coma Scale score
Time frame: 0 and 35 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erigo + Music, Erigo + Metronome and Erigo + Silence in people with Consciousness Disorders, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Frazzitta, MD (+39034492111, frazzittag62@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Coma Recovery Scale revised score (time frame: 0 and 35 days). 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 30 Sep 2016.