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

Ospedale Generale Di Zona Moriggia-Pelascini

Status: Unknown

Conditions: Consciousness Disorders

Treatments: Other: Erigo + Metronome; Other: Erigo + Silence; Other: Erigo + Music

Study type: Interventional

Funder types: Other

Identifiers

NCT02714491

Erigo.stim

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 3 patient groups

Music

Active Comparator group

Description:

Erigo + Music: During each stepping verticalization session the patient receives auditory stimulation (earphones) with previously preferred music

Treatment:

Other: Erigo + Music

Metronome

Active Comparator group

Description:

Erigo + Metronome: During each stepping verticalization session the patient receives auditory stimulation (earphones) with a metronome (rhythmic with the stepping movement)

Treatment:

Other: Erigo + Metronome

Silence

Active Comparator group

Description:

Erigo + Silence: During each stepping verticalization session the patient does note receive any auditory stimulation.

Treatment:

Other: Erigo + Silence