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

Primary Purpose

Disorders of Consciousness

Status

Completed

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

Active tPCS

Active tDCS

Sham tPCS

Sham tDCS

About this trial

This is an interventional treatment trial for Disorders of Consciousness

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University Hospital of Liege

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Active tPCS / Sham tDCS

Sham tPCS / Active tDCS

Sham tPCS / Sham tDCS

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Signal coherence and EEG power as measured by Quantitative electroencephalographic analysis (qEEG)

EEG measures cortical electrical activity and examines the dynamic changes.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03115021

First Posted

April 11, 2017

Last Updated

October 27, 2021

Sponsor

University of Liege

1. Study Identification

Unique Protocol Identification Number

NCT03115021

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

May 1, 2018 (Actual)

Primary Completion Date

September 30, 2019 (Actual)

Study Completion Date

October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Liege

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Disorders of Consciousness

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active tPCS / Sham tDCS

Arm Type

Experimental

Arm Description

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

Arm Title

Sham tPCS / Active tDCS

Arm Type

Experimental

Arm Description

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

Arm Title

Sham tPCS / Sham tDCS

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Active tPCS

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Active tDCS

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham tPCS

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham tDCS

Intervention Description

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.

Primary Outcome Measure Information:

Title

Signal coherence and EEG power as measured by Quantitative electroencephalographic analysis (qEEG)

Description

EEG measures cortical electrical activity and examines the dynamic changes.

Time Frame

It will be measured over the course of about 3 weeks

Secondary Outcome Measure Information:

Title

Coma Recovery Scale Revised (CRS-R)

Description

Time Frame

It will be measured over the course of about 3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

University Hospital of Liege

City

Liege

ZIP/Postal Code

4000

Country

Belgium

12. IPD Sharing Statement

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

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