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

Phase 1

Completed

• Conditions: Disorders of Consciousness

• Registration Number: NCT03115021
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-11
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-14
• Study Start: 2018-05-01
• Primary Completion: 2019-09-30
• Study Completion: 2019-10-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospital of Liege; 🇧🇪 Liege, Belgium