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Completed

NCT Number: NCT03115021

Neurophysiological Effects of tPCS and tDCS on Patients With Disorders of Consciousness

This study aims at comparing the effects of transcranial direct current stimulation and transcranial pulsed current stimulation on neurophysiological outcomes on patients with disorders of consciousness. This study also aims to evaluate the effects of these techniques on patients' level of consciousness.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital 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

  • Fluent in English or French
  • Legally authorized surrogate available to provide informed consent
  • History of non-traumatic brain injury with loss of consciousness caused by stroke, cerebral hemorrhage, hypoxic ischemic insult, metabolic disorder or infection.
  • Has been followed clinically on the CRS-R for a minimum two weeks and has undergone a minimum of 4 assessments with the CRS-R.
  • Serial CRS-R scores show at least one subscale on which there is no behavioral sign of conscious awareness (ie, command following, visual fixation or pursuit, object localization or recognition, localization to noxious stimulation, object manipulation, automatic motor responses, functional object use, discernable speech, discernable yes no communication, based on clinically obtained scores contained in the medical record).
  • CRS-R screening examination completed by research staff confirms the absence of a behavioral sign of consciousness on a least one CRS-R subscale.
  • Medically stable (i.e., no systemic illness or disease) and capable of independent ventilation

Exclusion criteria

  • History of developmental, neurologic, or major psychiatric disorder resulting in functional disability up to time of enrollment.
  • Evidence or surrogate report of uncontrolled seizure disorder
  • Metallic brain implant or implanted electronic brain medical devices or pacemaker
  • Subjects with craniectomy
  • History of cranioplasty in the frontal region or recent cranioplasty that has not yet fully healed
  • Pregnancy

Treatment and study plan

Active tPCS

Device

A current intensity of 2na and a stimulation frequency range of 6-10 Hz will be used with a peri-auricular ear-clip electrode montage for 20 minutes.

active tDCS

Device

A current intensity of 2mA will be used for 20minutes. The electrodes that will be used will be standard sponge electrodes. The anode will be place over the left prefrontal cortex and the cathode over the right supraorbitofrontal area.

Sham tPCS

Device

Sham tPCS will consist of applying the same parameters as for active but the corresponding device will be turned off after 30 seconds as to simulate the initial sensation of the active current. A current of 2mA will still be used (but turned off after 30 sec). The electrodes that will be used will be the same as for the active tPCS condition and the electrodes placement as well.

Sham tDCS

Device

Sham tDCS will consist of applying the same parameters as for active but the corresponding device will be turned off after 30 seconds as to simulate the initial sensation of the active current. A current of 2mA will still be used (but turned off after 30 sec). The electrodes that will be used will be the same as for the active tDCS condition and the electrodes placement as well.

Primary outcomes

  1. Signal coherence and EEG power as measured by Quantitative electroencephalographic analysis (qEEG)

    Time frame: It will be measured over the course of about 3 weeks

    EEG measures cortical electrical activity and examines the dynamic changes.

Secondary outcomes

  1. Coma Recovery Scale Revised (CRS-R)

    Time frame: It will be measured over the course of about 3 weeks

    The CRS-R is a standard clinical protocol used to assess patients' level of consciousness. This test measures the level of response to sensory stimulation, ability to understand language and to communicate.

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 14, 2017
Registry last updated
Oct 28, 2021

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.

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