Long-term Effect of tDCS in Patients With Disorders of Consciousness

Summary

In this multicentric double-blind sham controlled study, the investigators plan to assess the effects of 20 sessions of tDCS on long-term behavioral recovery in patients with disorders of consciousness. Neurophysiological outcomes (EEG) will also be collected.

This research will 1) determine whether long-term behavioral recovery can be promoted with tDCS and 2) generate knowledge regarding the impact of tDCS on neurophysiological outcome (i.e., EEG) in severely brain injured patients. The investigators will compare the effects of active and sham tDCS on behavioral assessments and quantitative EEG in patients with severe brain injury and its potential application in rehabilitation.

Conditions

• Disorder of Consciousness

Interventions

DEVICE

transcranial direct current stimulation - active

transcranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes.

DEVICE

transcranial direct current stimulation - sham

transcranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes. The sham intervention consists of 30 seconds of stimulation at the beginning and the end of the 20minutes of intervention.

Sponsors & Collaborators

• Fondazione Salvatore Maugeri, Italy

  collaborator UNKNOWN

• Université Catholique de Louvain, Belgium

  collaborator UNKNOWN

• Hospitales Nisa, Spain

  collaborator UNKNOWN

• I.R.C.C.S. Fondazione Santa Lucia, Italy

  collaborator UNKNOWN

• Schoen Clinic Bad Aibling, Germany

  collaborator UNKNOWN

• Research Center of Neurology, Russia

  collaborator OTHER_GOV

• Therapiezentrum Burgau, Germany

  collaborator UNKNOWN

• pavlov state medical university, Russia

  collaborator UNKNOWN

• Azienda Unita Sanitaria Locale di Piacenza, Italy

  collaborator UNKNOWN

• University of Liege

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-01

Primary Completion

2021-12-24

Completion

2021-12-24

Countries

• Belgium

Study Locations