Skip to main content
OpenTrials
Completed

NCT Number: NCT03114397

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Disorder of Consciousness Consciousness Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Liege

Liège, 4000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CNS medication stable for at least a week
  • Stable diagnosis (no diagnosis change based on 2 CRS-R performed within 1 week).
  • Between 3 and 24 months post injury
  • Structural MRI or CT-scan (to evidence focal lesions on the left DLPFC)

Exclusion criteria

  • Craniotomies encompassing the frontal region (electrodes location)
  • VPS under the stimulated area (prefrontal cortex)
  • Pacemaker
  • Metallic cerebral implant
  • Severe medical conditions that might influence clinical diagnosis and EEG activity (e.g., severe hepatic insufficiency or renal failure, or sub-continuous or abundant epileptiform discharges on standard EEG recordings).

Treatment and study plan

transcranial direct current stimulation - active

Device

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

Transcranial direct current stimulation - Sham

Device

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.

Primary outcomes

  1. Change in the CRS-R total score

    Time frame: 4 weeks

    Improvement of the CRS-R total score after the end of the anodal session.

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Collaborators

  • Azienda Unita Sanitaria Locale di Piacenza
  • Fondazione Salvatore Maugeri, Italy
  • Hospitales Nisa, Spain
  • I.R.C.C.S. Fondazione Santa Lucia, Italy
  • Research Center of Neurology, Russia
  • Schoen Clinic Bad Aibling, Germany
  • Therapiezentrum Burgau, Germany
  • Université Catholique de Louvain
  • pavlov state medical university, Russia

Registry information

Official study title

Long-term Effect of 20 Sessions of Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness: a Double Blind Sham Controlled Clinical Trial.

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 14, 2017
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.