CONsciousness Transcranial Electric STimulation

Summary

The aim of this study is to investigate the effect of transcranial Alternating Current Stimulation (tACS) at theta frequency and the the effect of transcranial Direct Current Stimulation (tDCS) on the conscious state of non-communicating patients. tACS and tDCS are non-invasive stimulation techniques that are used to induce brain oscillations at certain frequency or to increase the brain activity in applied region.

Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of consciousness and functional communication in some Minimally Conscious State (MCS) patients, and in some Vegetative State (VS) patients. However the optimal intensity of electrical current stimulation remains unknown and transcranial Alternative Current Stimulation (tACS), with the ability to stimulate cortex at specific frequencies and to manipulate phase-synchrony between regions is a promising techniques to improve patients' consciousness.

In this study, the investigators will use prefrontal tDCS and theta tACS to improve patients consciousness level.

Conditions

• Disorder of Consciousness

Interventions

DEVICE

In-phase 6 Hz prefronto-parietal tACS

tACS is a non-invasive stimulation technique that works by delivering a weak sinusoidally oscillating electrical current to the surface of the skull to entrain oscillations in the brain.

DEVICE

Sham prefronto-parietal tACS

tACS is a non-invasive stimulation technique that works by delivering a weak sinusoidally oscillating electrical current to the surface of the skull to entrain oscillations in the brain.

DEVICE

2 mA left prefrontal tDCS

tDCS is a form of neuromodulation method where very low levels of constant current are delivered to specifically targeted areas of the brain

DEVICE

Sham left prefrontal tDCS

tDCS is a form of neuromodulation method where very low levels of constant current are delivered to specifically targeted areas of the brain

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France

  lead OTHER_GOV

Principal Investigators

• Jacobo D Sitt, MD, PhD · CR-ICM U 975 /UMRS INSERM 1127

• Lionel Naccache, MD, PhD · CR-ICM U 975 /UMRS INSERM 1127

• Bertrand Hermann, MD · CR-ICM U 975 /UMRS INSERM 1127

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-19

Primary Completion

2022-10-31

Completion

2024-01-03

Countries

• France

Study Locations