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

University of Liege

Status and phase: Completed; Phase 1

Conditions: Disorders of Consciousness

Treatments: Device: Sham tPCS; Device: Active tDCS; Device: Sham tDCS; Device: Active tPCS

Study type: Interventional

Funder types: Other

Identifiers

NCT03115021

2016P001840

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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12 participants in 3 patient groups

Active tPCS / Sham tDCS

Experimental group

Description:

All subject will receive active tPCS and sham tDCS for 20 minutes simultaneously.

Treatment:

Device: Active tPCS

Device: Sham tDCS

Sham tPCS / Active tDCS

Experimental group

Description:

All subject will receive sham tPCS and active tDCS for 20 minutes simultaneously.

Treatment:

Device: Active tDCS

Device: Sham tPCS

Sham tPCS / Sham tDCS

Experimental group

Description:

All subject will receive sham tPCS and sham tDCS for 20 minutes simultaneously.

Treatment:

Device: Sham tPCS

Device: Sham tDCS