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

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ClinicalTrials.gov Identifier: NCT03115021
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Aurore Thibaut, University of Liege

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Disorders of Consciousness Device: Active tPCS Device: Active tDCS Device: Sham tPCS Device: Sham tDCS Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neurophysiological Effects of tPCS and tDCS on Patients With Disorders of Consciousness
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : October 30, 2019

Arm Intervention/treatment
Experimental: Active tPCS / Sham tDCS
All subject will receive active tPCS and sham tDCS for 20 minutes simultaneously.
Device: Active tPCS
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.

Device: Sham tDCS
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.

Experimental: Sham tPCS / Active tDCS
All subject will receive sham tPCS and active tDCS for 20 minutes simultaneously.
Device: Active tDCS
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.

Device: Sham tPCS
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.

Experimental: Sham tPCS / Sham tDCS
All subject will receive sham tPCS and sham tDCS for 20 minutes simultaneously.
Device: Sham tPCS
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.

Device: Sham tDCS
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 Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fluent in English
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115021


Contacts
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Contact: Aurore Thibaut, Prof 003243668069 athibaut@ulg.ac.be
Contact: Alice Barra, PhD 003243668069 abarra@uliege.be

Locations
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Belgium
University Hospital of Liege Recruiting
Liege, Belgium, 4000
Contact: Aurore Thibaut, PhD    003243668069    athibaut@ulg.ac.be   
Contact: Alice Barra, MSc    003243668069    abarra@uliege.be   
Sponsors and Collaborators
University of Liege

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Responsible Party: Aurore Thibaut, Investigator, University of Liege
ClinicalTrials.gov Identifier: NCT03115021     History of Changes
Other Study ID Numbers: 2016P001840
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Consciousness Disorders
Disease
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders