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Sub-study of the NEURODOC Project : Neurophysiological Evaluation of a Routine Care Open Label tDCS Session

NCT04035655 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2019-07-29

No results posted yet for this study

Summary

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 mechanisms by which tDCS improves consciousness are poorly understood and the electrophysiological effects of such a stimulation have never been studied in disorders of consciousness patients.

In this study, the investigators will use detailed clinical examinations and electrophysiological assessments (quantitative high-density EEG and event-related potentials) to assess the effect of a open-label single session of left dorsolateral prefrontal cortex tDCS stimulation administered as routine care.

Conditions

Interventions

BEHAVIORAL

Coma Recovery Scale - revised

Assessment of the level of consciousness by the dedicated Coma Recovery Scale - Revised, current gold-standard in consciousness level assessment. Assessment before and after the tDCS session (immediately before and after the electrophysiological assessment, see below).

DIAGNOSTIC_TEST

Electrophysiological recordings

The electrophysiological assessment consisted of: * a 5 minutes resting state high-density EEG recording * a approximately 6 minutes auditory oddball paradigm These two procedures were administered immediately before and after the tDCS session

Sponsors & Collaborators

  • Groupe Hospitalier Pitie-Salpetriere

    lead OTHER

Principal Investigators

  • Lionel Naccache, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-09-30
Completion
2018-09-30
FDA Device
Yes

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04035655 on ClinicalTrials.gov