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Two Intensities of Transcranial Direct Current Stimulation to Improve Consciousness in Severely Brain Injured Patients (STIMCOM)

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ClinicalTrials.gov Identifier: NCT03007784
Recruitment Status : Recruiting
First Posted : January 2, 2017
Last Update Posted : January 18, 2017
Sponsor:
Collaborators:
Hôpital Raymond Poincaré
Hospices Civils de Lyon
Information provided by (Responsible Party):
LIONEL NACCACHE, Groupe Hospitalier Pitie-Salpetriere

Brief 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 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.


Condition or disease Intervention/treatment Phase
Disorder of Consciousness Minimally Conscious State Vegetative State Cognitive Impairment Device: transcranial direct current stimulation (tDCS) / Comparison of current intensities Phase 3

Detailed Description:
This study will use a cross-over double-blind design with each patient receiving both current intensities in a randomized order during 4 weeks (2 weeks for each tDCS intensity, totalizing a number of 10X2 stimulation sessions of 20 minutes each).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2017
Estimated Primary Completion Date : January 2021

Arm Intervention/treatment
Experimental: 2 mA anodal tDCS stimulation
Anodal tDCS stimulation at 2 mA applied to the left dorsolateral prefrontal during 20 minutes five days a week for two consecutive weeks
Device: transcranial direct current stimulation (tDCS) / Comparison of current intensities
Active Comparator: 0.2 mA anodal tDCS stimulation
Anodal tDCS stimulation at 0.2 mA applied to the left dorsolateral prefrontal during 20 minutes five days a week for two consecutive weeks
Device: transcranial direct current stimulation (tDCS) / Comparison of current intensities



Primary Outcome Measures :
  1. Change of the Coma Recovery Scale-Revised score according to tDCS current intensity (2mA versus 0.2mA) [ Time Frame: Last Day of 0.2mA session (Day 14th or Day 28th) versus Last Day of 2mA session (Day 14th or Day 28th) ]
    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)

  2. Change from baseline of the Coma Recovery Scale-Revised score after 2mA tDCS current intensity [ Time Frame: Last Day of 2mA session (Day 14th or Day 28th) versus baseline (Day 1st) ]
    Comparison of the CRS-R score at the tenth day of 2mA stimulation (Day14 or Day28) with the score at baselne (Day1)

  3. Change from baseline of the Coma Recovery Scale-Revised score after 0.2mA tDCS current intensity [ Time Frame: Last Day of 0.2mA session (Day 14th or Day 28th) versus baseline (Day 1st) ]
    Comparison of the CRS-R score at the tenth day of 0.2mA stimulation (Day14 or Day28) with the score at baselne (Day1)


Secondary Outcome Measures :
  1. 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 [ Time Frame: Last Day of 2mA session (Day 14th or Day 28th) versus Last Day of 0.2mA session (Day 14th or Day 28th) ]
    Statistical comparison of local (MMN, automatic CNV) and global (P3b; modulation of CNV) ERP effects recorded after 10 days of 2mA tDCS stimulation (Day 14th or Day 28th) and after 10 days of 0.2mA tDCS stimulation (Day 14th or Day 28th)

  2. Change from baseline of the ERPS recorded during the "local global" auditory paradigm (Bekinschtein et al., PNAS 2009) after 2mA tDCS current intensity [ Time Frame: Last Day of 2mA session (Day 14th or Day 28th) versus baseline (Day 1st) ]
    Statistical comparison of local (MMN, automatic CNV) and global (P3b; modulation of CNV) ERP effects recorded at baseline (Day 1) and after 10 days of 2mA tDCS stimulation

  3. Change from baseline of the ERPS recorded during the "local global" auditory paradigm (Bekinschtein et al., PNAS 2009) after 0.2mA tDCS current intensity [ Time Frame: Last Day of 0.2mA session (Day 14th or Day 28th) versus baseline (Day 1st) ]
    Statistical comparison of local (MMN, automatic CNV) and global (P3b; modulation of CNV) ERP effects recorded at baseline (Day 1) and after 10 days of 0.2mA tDCS stimulation

  4. 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 [ Time Frame: Last Day of 2mA session (Day 14th or Day 28th) versus Last Day of 0.2mA session (Day 14th or Day 28th) ]
    Statistical comparison of the multivariate automatic classification of conscious state from EEG (Sitt et al., Brain 2014) after 10 days of 2mA tDCS stimulation (Day 14th or Day 28th) and after 10 days of 0.2mA tDCS stimulation (Day 14th or Day 28th)

  5. 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 [ Time Frame: Last Day of 2mA session (Day 14th or Day 28th) versus baseline (Day 1st) ]
    Statistical comparison of the multivariate automatic classification of conscious state from EEG (Sitt et al., Brain 2014) at baseline (Day 1st) and after 10 days of 2mA tDCS stimulation (Day 14th or Day 28th) and after 10 days of 2mA tDCS stimulation (Day 14th or Day 28th)

  6. Change from baseline of the multivariate automatic classification of conscious state from EEG (Sitt et al., Brain et al. 2014) after 10 days of 0.2mA tDCS current intensity [ Time Frame: Last Day of 0.2mA session (Day 14th or Day 28th) versus baseline (Day 1st) ]
    Statistical comparison of the multivariate automatic classification of conscious state from EEG (Sitt et al., Brain 2014) at baseline (Day 1st) and after 10 days of 2mA tDCS stimulation (Day 14th or Day 28th) and after 10 days of 0.2mA tDCS stimulation (Day 14th or Day 28th)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non communicative patients (including conscious patients but presenting with major fluctuations of vigilance and/or of cognitive abilities)
  • Patients with stable clinical examination
  • Age between 18 and 80 years
  • Brain injury confirmed by cerebral imaging (MRI or TDM)
  • Disorder of consciousness diagnosed by CRS-R (VS, MCS, exitMCS)

Exclusion Criteria:

  • Status epilepticus
  • Severely neurodegenerative illnesses (Alzheimer disease, Lewy Body Dementia)
  • Pregnancy
  • Patients underage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03007784


Contacts
Contact: Jacobo Sitt, MD PhD +33 1 57 27 43 17 jacobo.sitt@icm-institute.org
Contact: Bertrand Hermann, MD Msc +33 1 57 27 43 14 bertrand.hermann@icm-institute.org

Locations
France
Groupe Hospitalier Pitié-Salpêtrière Recruiting
Paris, France, 75013
Contact: Lionel Naccache, MD, PhD    +33157274314    lionel.naccache@gmail.com   
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Hôpital Raymond Poincaré
Hospices Civils de Lyon
Investigators
Study Director: Lionel Naccache, MD PhD Paris 6 University ICM Inserm APHP

Responsible Party: LIONEL NACCACHE, MD, PhD, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT03007784     History of Changes
Other Study ID Numbers: SC20160427
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017

Keywords provided by LIONEL NACCACHE, Groupe Hospitalier Pitie-Salpetriere:
Consciousness
Disorder of consciousness
Minimally conscious state
Vegetative state
Exit-MCS
Transcranial direct current stimulation (tDCS)
CRS-R
EEG
Cognitive ERPs

Additional relevant MeSH terms:
Cognitive Dysfunction
Consciousness Disorders
Persistent Vegetative State
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Unconsciousness