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

NCT03115021 | Completed Phase 1

• 1 other identifier: 2016P001840
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorders of Consciousness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Coma Recovery Scale Revised (CRS-R)

  It will be measured over the course of about 3 weeks

Study Arms (3)

Active tPCS / Sham tDCS

EXPERIMENTAL

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

Device: Active tPCS; Device: Sham tDCS

Sham tPCS / Active tDCS

EXPERIMENTAL

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

Device: Active tDCS; Device: Sham tPCS

Sham tPCS / Sham tDCS

EXPERIMENTAL

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

Device: Sham tPCS; Device: Sham tDCS

Interventions

Active tPCS DEVICE

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 tPCS / Sham tDCS

Active tDCS DEVICE

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 / Active tDCS

Sham tPCS DEVICE

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 tPCS / Active tDCS; Sham tPCS / Sham tDCS

Sham tDCS DEVICE

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.

Active tPCS / Sham tDCS; Sham tPCS / Sham tDCS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

University Hospital of Liege

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 14, 2017
• Study Start: May 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: October 30, 2019
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

BE (1)