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

Not Applicable

• Conditions: Consciousness Disorders
• Interventions: Other: Erigo + Music; Other: Erigo + Silence; Other: Erigo + Metronome

• Registration Number: NCT02714491
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-03-10
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-21
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-29
• Last Update Posted: 2016-09-30
• Primary Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music	Erigo + Music	Erigo + Music: During each stepping verticalization session the patient receives auditory stimulation (earphones) with previously preferred music
Silence	Erigo + Silence	Erigo + Silence: During each stepping verticalization session the patient does note receive any auditory stimulation.
Metronome	Erigo + Metronome	Erigo + Metronome: During each stepping verticalization session the patient receives auditory stimulation (earphones) with a metronome (rhythmic with the stepping movement)

Primary Outcome Measures

Name	Time	Method
change in Coma Recovery Scale revised score	0 and 35 days

Secondary Outcome Measures

Name	Time	Method
change in quantitative EEG parameters	0 and 35 days
change in Glasgow Coma Scale score	0 and 35 days
change in Disability Rating Scale score	0 and 35 days
change in Levels of Cognitive Functioning score	0 and 35 days

Trial Locations

Locations (1)

Ospedale Generale di Zona Moriggia Pelascini; 🇮🇹 Gravedona ed Uniti, CO, Italy