Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-12-31

Brief Summary

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Previous studies showed that anodal transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal (DLPF) cortex transiently improves performance of memory and attention. Investigator assessed the effects of left DLPF-tDCS on Coma Recovery Scale-Revised (CRS-R) scores in severely brain damaged patients with disorders of consciousness in a double-blind sham-controlled experimental design.

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Detailed Description

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Following severe brain damage and coma, some patients may remain in a vegetative state (VS) or minimally conscious state (MCS). At present, there are no evidence-based guidelines regarding the treatment of patients with disorders of consciousness (DOC).

Investigator aim to assess the effect of single session anodal (i.e., excitatory) transcranial direct current stimulation (tDCS) of the left dorsolateral prefrontal cortex (DLPF) on the level of consciousness in DOC patients in a double blind randomized sham controlled study.

tDCS is a form of safe non-invasive cortical stimulation, modulating cortical excitability at stimulation sites via weak polarizing currents, previously reported to transiently improve working memory and attention by stimulating the left DLPF in healthy subjects and patients with stroke, Parkinson's or Alzheimer's disease.

Conditions

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Vegetative State Minimally Conscious State Disorders of Consciousness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Anodal tDCS

Patients received anodal tDCS (on DLPF cortex) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)

Group Type ACTIVE_COMPARATOR

Anodal tDCS

Intervention Type DEVICE

patients received anodal tDCS (on PFDL cortex) during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised)

sham tDCS

Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation.

Group Type SHAM_COMPARATOR

sham tDCS

Intervention Type DEVICE

Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation.

Interventions

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Anodal tDCS

patients received anodal tDCS (on PFDL cortex) during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised)

Intervention Type DEVICE

sham tDCS

Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* post-comatose patients
* patients in vegetative/unresponsive or minimally conscious state
* patients with stable cardiorespiratory parameters
* patients free of sedative drugs and Na+ or Ca++ channel blockers (e.g., carbamazepine) or NMDA receptor antagonists (e.g., dextromethorphan)

Exclusion Criteria

* premorbit neurology antecedent
* patients in coma or \<1week after the acute brain insult
* patients with a metallic cerebral implant or a pacemaker (in line with the safety criteria for tDCS in humans)

Minimum Eligible Age

15 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No