Disorders of Consciousness
Conditions
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.
Interventions
DEVICEActive 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.
DEVICEActive 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.
DEVICESham 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.
DEVICESham 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.
Sponsors
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Signal coherence and EEG power as measured by Quantitative electroencephalographic analysis (qEEG) | It will be measured over the course of about 3 weeks | EEG measures cortical electrical activity and examines the dynamic changes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coma Recovery Scale Revised (CRS-R) | 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. |
Countries
Belgium
Outcome results
None listed