NCT03007784|UnknownPhase 3
Two Intensities of Transcranial Direct Current Stimulation to Improve Consciousness in Severely Brain Injured Patients
STIMCOM
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STIMCOM
Sponsor study identifier
interventional
300
1 country
1
Study Start
January 2017
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
Not reported
Date not reportedLimited 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. This study will test the effects of two intensities of tDCS stimulation (either 0.2mA or 2mA) applied on left dorso-lateral prefrontal cortex on both behavior, - assessed by the Coma Recovery Scale-Revised (CRS-R) scores -, as well as quantified EEG recorded during resting state (using algorithms previously designed and published by the investigators) and event-related potentials (using auditory paradigms we previously published) in severely brain damaged patients with disorders of consciousness (MCS, VS, and conscious but cognitively disabled patients) of various etiologies.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 22, 2016
Actual (reported)January 2017
Date type not reportedThis date has not been verified as actual or estimated.
January 2, 2017
Actual (reported)January 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change of the Coma Recovery Scale-Revised score according to tDCS current intensity (2mA versus 0.2mA)
Comparison of the CRS-R score at the tenth day of 0.2mA stimulation (Day14 or Day28) with the score at the tenth day of 2mA stimulation (Day14 or Day28)
Last Day of 0.2mA session (Day 14th or Day 28th) versus Last Day of 2mA session (Day 14th or Day 28th)
Change from baseline of the Coma Recovery Scale-Revised score after 2mA tDCS current intensity
Comparison of the CRS-R score at the tenth day of 2mA stimulation (Day14 or Day28) with the score at baselne (Day1)
Last Day of 2mA session (Day 14th or Day 28th) versus baseline (Day 1st)
Change from baseline of the Coma Recovery Scale-Revised score after 0.2mA tDCS current intensity
Anodal tDCS stimulation at 2 mA applied to the left dorsolateral prefrontal during 20 minutes five days a week for two consecutive weeks
Anodal tDCS stimulation at 0.2 mA applied to the left dorsolateral prefrontal during 20 minutes five days a week for two consecutive weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Groupe Hospitalier Pitié-Salpêtrière
Paris, 75013, France
Lionel Naccache, MD PhD
Paris 6 University ICM Inserm APHP
First Submitted
December 22, 2016
First Posted
January 2, 2017
Study Start
January 2017
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness
Comparison of the CRS-R score at the tenth day of 0.2mA stimulation (Day14 or Day28) with the score at baselne (Day1)
Last Day of 0.2mA session (Day 14th or Day 28th) versus baseline (Day 1st)
IChange of the ERPS recorded during the "local global" auditory paradigm (Bekinschtein et al., PNAS 2009) after 10 days of 2mA tDCS current intensity and after 10 days of 0.2mA tDCS current intensity
Last Day of 2mA session (Day 14th or Day 28th) versus Last Day of 0.2mA session (Day 14th or Day 28th)
Change from baseline of the ERPS recorded during the "local global" auditory paradigm (Bekinschtein et al., PNAS 2009) after 2mA tDCS current intensity
Last Day of 2mA session (Day 14th or Day 28th) versus baseline (Day 1st)
Change from baseline of the ERPS recorded during the "local global" auditory paradigm (Bekinschtein et al., PNAS 2009) after 0.2mA tDCS current intensity
Last Day of 0.2mA session (Day 14th or Day 28th) versus baseline (Day 1st)
IChange of the multivariate automatic classification of conscious state from EEG (Sitt et al., Brain et al. 2014) after 10 days of 2mA tDCS current intensity and after 10 days of 0.2mA tDCS current intensity
Last Day of 2mA session (Day 14th or Day 28th) versus Last Day of 0.2mA session (Day 14th or Day 28th)
Change from baseline of the multivariate automatic classification of conscious state from EEG (Sitt et al., Brain et al. 2014) after 10 days of 2mA tDCS current intensity
Last Day of 2mA session (Day 14th or Day 28th) versus baseline (Day 1st)
Contact the study team to confirm eligibility.
January 2021
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 18, 2017
Record last verified: 2017-01
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Source: ClinicalTrials.gov.
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