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

NCT03007784 | Unknown Phase 3

• 1 other identifier: SC20160427
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder of Consciousness; Minimally Conscious State; Vegetative State; Cognitive Impairment

Keywords

Consciousness; Disorder of consciousness; Minimally conscious state; Vegetative state; Exit-MCS; Transcranial direct current stimulation (tDCS); CRS-R; EEG; Cognitive ERPs

Outcome Measures

Primary Outcomes (3)

• 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

  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)

Secondary Outcomes (6)

• 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)

Study Arms (2)

2 mA anodal tDCS stimulation

EXPERIMENTAL

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

0.2 mA anodal tDCS stimulation

ACTIVE COMPARATOR

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

Interventions

transcranial direct current stimulation (tDCS) / Comparison of current intensities DEVICE

0.2 mA anodal tDCS stimulation; 2 mA anodal tDCS stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Groupe Hospitalier Pitie-Salpetriere: lead
• Hôpital Raymond Poincaré: collaborator
• Hospices Civils de Lyon: collaborator

Study Sites (1)

Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Consciousness Disorders; Persistent Vegetative State; Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Unconsciousness; Cognition Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Lionel Naccache, MD PhD

  Paris 6 University ICM Inserm APHP

  STUDY DIRECTOR

Central Study Contacts

Jacobo Sitt, MD PhD

CONTACT

+33 1 57 27 43 17; jacobo.sitt@icm-institute.org

Bertrand Hermann, MD Msc

CONTACT

+33 1 57 27 43 14; bertrand.hermann@icm-institute.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: January 2, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2021
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

FR (1)