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

Consciousness Disorders Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02714491
• Other study ID #: Erigo.stim
• Status: Recruiting
• Phase: N/A
• First received: March 10, 2016
• Last updated: September 29, 2016
• Start date: June 2015

Study information

• Verified date: September 2016
• Source: Ospedale Generale Di Zona Moriggia-Pelascini
• Contact: Giuseppe Frazzitta, MD
• Phone: +39034492111
• Email: frazzittag62[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Consciousness Disorders

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Italy	Ospedale Generale di Zona Moriggia Pelascini	Gravedona ed Uniti	CO

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Generale Di Zona Moriggia-Pelascini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Coma Recovery Scale revised score		0 and 35 days	No
Secondary	change in Levels of Cognitive Functioning score		0 and 35 days	No
Secondary	change in Disability Rating Scale score		0 and 35 days	No
Secondary	change in quantitative EEG parameters		0 and 35 days	No
Secondary	change in Glasgow Coma Scale score		0 and 35 days	No