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

September 29, 2016 updated by: Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • CO
      • Gravedona ed Uniti, CO, Italy, 22015
        • Recruiting
        • Ospedale Generale di Zona Moriggia Pelascini
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in Coma Recovery Scale revised score
Time Frame: 0 and 35 days
0 and 35 days

Secondary Outcome Measures

Outcome Measure
Time Frame
change in Levels of Cognitive Functioning score
Time Frame: 0 and 35 days
0 and 35 days
change in Disability Rating Scale score
Time Frame: 0 and 35 days
0 and 35 days
change in quantitative EEG parameters
Time Frame: 0 and 35 days
0 and 35 days
change in Glasgow Coma Scale score
Time Frame: 0 and 35 days
0 and 35 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

June 1, 2017

Study Completion

December 8, 2022

Study Registration Dates

First Submitted

March 10, 2016

First Submitted That Met QC Criteria

March 15, 2016

First Posted (Estimate)

March 21, 2016

Study Record Updates

Last Update Posted (Estimate)

September 30, 2016

Last Update Submitted That Met QC Criteria

September 29, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Erigo.stim

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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