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NCT Number: NCT01673126

Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness

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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Key information

Conditions

Vegetative State Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Consciousness Disorders Disorders of Consciousness Mental Disorders Minimally Conscious State Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Persistent Vegetative State Signs and Symptoms Unconsciousness

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital of Liège

Liège, 4000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Anodal tDCS

Device

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

Sham tDCS

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.

Primary outcomes

  1. Change in CRS-R Total Scores

    Time frame: Baseline and directly after the tDCS (20 minutes)

    At the group level, assess the modification of CRS-R total scores in anodal tDCS as compared to sham stimulation in VS/UWS and MCS populations

    The Coma Recovery Scale Revised (CRS-R) is a behavioral scale performed at the patient's bedside. It consists of 23 hierarchically arranged items that comprise 6 subscales addressing auditory, visual, motor, verbal, communication, and arousal functions.

    Scoring is based on the presence or absence of specific behavioral responses to sensory stimuli administered in a standardized manner. Maximum scores of each subscale are summed to obtain the total score (from 0 to 23).

    The lowest item on each subscale represents reflexive activity, whereas the highest items represent cognitively mediated behaviors.

Secondary outcomes

  1. Influence of Diagnosis on the Results

    Time frame: participants will be followed for the duration of 1 year

  2. Influence of Etiology on the Results

    Time frame: participants will be followed for the duration of 1 year

  3. Influence of Time Since Insult on the Results

    Time frame: participants will be followed for the duration of 1 year

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness: a Sham-controlled Randomised Double Blind Study

Acronym: tDCS in DOC

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Aug 27, 2012
Registry last updated
Jun 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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