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Effects of Auditory Stimulation During Verticalization With Erigo in Patients With Disorder of Consciousness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714491
Recruitment Status : Unknown
Verified September 2016 by Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini.
Recruitment status was:  Recruiting
First Posted : March 21, 2016
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini

Brief 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.

Condition or disease Intervention/treatment Phase
Consciousness Disorders Other: Erigo + Music Other: Erigo + Metronome Other: Erigo + Silence Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Study Start Date : June 2015
Estimated Primary Completion Date : June 2017

Arm Intervention/treatment
Active Comparator: Music
Erigo + Music: During each stepping verticalization session the patient receives auditory stimulation (earphones) with previously preferred music
Other: Erigo + Music
The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with "Erigo" (3/week for 5 consecutive weeks) and musical stimulation.

Active Comparator: Metronome
Erigo + Metronome: During each stepping verticalization session the patient receives auditory stimulation (earphones) with a metronome (rhythmic with the stepping movement)
Other: Erigo + Metronome
The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with "Erigo" (3/week for 5 consecutive weeks) and metronome stimulation.

Active Comparator: Silence
Erigo + Silence: During each stepping verticalization session the patient does note receive any auditory stimulation.
Other: Erigo + Silence
The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with "Erigo" (3/week for 5 consecutive weeks), without auditory stimulation.




Primary Outcome Measures :
  1. change in Coma Recovery Scale revised score [ Time Frame: 0 and 35 days ]

Secondary Outcome Measures :
  1. change in Levels of Cognitive Functioning score [ Time Frame: 0 and 35 days ]
  2. change in Disability Rating Scale score [ Time Frame: 0 and 35 days ]
  3. change in quantitative EEG parameters [ Time Frame: 0 and 35 days ]
  4. change in Glasgow Coma Scale score [ Time Frame: 0 and 35 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Vegetative State or Minimally Conscious State diagnosis
  • >3 months from acute brain injury

Exclusion Criteria:

  • No clinical stability
  • Sepsis
  • Orthopaedic contraindications for verticalization
  • Deep Vein Thrombosis
  • weight >130 Kg
  • height >210 cm

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714491


Contacts
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Contact: Giuseppe Frazzitta, MD +39034492111 frazzittag62@gmail.com

Locations
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Italy
Ospedale Generale di Zona Moriggia Pelascini Recruiting
Gravedona ed Uniti, CO, Italy, 22015
Contact: Giuseppe Frazzitta, MD    +39034492111    frazzittag62@gmail.com   
Sponsors and Collaborators
Ospedale Generale Di Zona Moriggia-Pelascini
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Responsible Party: Ilaria Zivi, MD, Ospedale Generale Di Zona Moriggia-Pelascini
ClinicalTrials.gov Identifier: NCT02714491    
Other Study ID Numbers: Erigo.stim
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders