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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03115021
Other study ID # 2016P001840
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 1, 2018
Est. completion date October 30, 2019

Study information

Verified date October 2021
Source University of Liege
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date October 30, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.
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.

Locations

Country Name City State
Belgium University Hospital of Liege Liege

Sponsors (1)

Lead Sponsor Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Signal coherence and EEG power as measured by Quantitative electroencephalographic analysis (qEEG) EEG measures cortical electrical activity and examines the dynamic changes. It will be measured over the course of about 3 weeks
Secondary Coma Recovery Scale Revised (CRS-R) 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. It will be measured over the course of about 3 weeks
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