Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness

NCT01673126 | Completed Phase 2 Results

• 1 other identifier: 2009/201
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vegetative State; Minimally Conscious State; Disorders of Consciousness

Keywords

vegetative state; minimally conscious state; disorders of consciousness; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• Change in CRS-R Total Scores

  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.

  Baseline and directly after the tDCS (20 minutes)

Secondary Outcomes (3)

• Influence of Diagnosis on the Results

  participants will be followed for the duration of 1 year

• Influence of Etiology on the Results

  participants will be followed for the duration of 1 year

• Influence of Time Since Insult on the Results

  participants will be followed for the duration of 1 year

Study Arms (2)

Anodal tDCS

ACTIVE COMPARATOR

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

Device: Anodal tDCS

sham tDCS

SHAM COMPARATOR

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.

Device: sham tDCS

Interventions

Anodal tDCS DEVICE

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

Anodal tDCS

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.

sham tDCS

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

University Hospital of Liège

Liège, Liège, 4000, Belgium

Location

Related Publications (8)

• Multi-Society Task Force on PVS. Medical aspects of the persistent vegetative state (1). N Engl J Med. 1994 May 26;330(21):1499-508. doi: 10.1056/NEJM199405263302107.

  PMID: 7818633 BACKGROUND

• Giacino JT, Ashwal S, Childs N, Cranford R, Jennett B, Katz DI, Kelly JP, Rosenberg JH, Whyte J, Zafonte RD, Zasler ND. The minimally conscious state: definition and diagnostic criteria. Neurology. 2002 Feb 12;58(3):349-53. doi: 10.1212/wnl.58.3.349.

  PMID: 11839831 BACKGROUND

• Nitsche MA, Fricke K, Henschke U, Schlitterlau A, Liebetanz D, Lang N, Henning S, Tergau F, Paulus W. Pharmacological modulation of cortical excitability shifts induced by transcranial direct current stimulation in humans. J Physiol. 2003 Nov 15;553(Pt 1):293-301. doi: 10.1113/jphysiol.2003.049916. Epub 2003 Aug 29.

  PMID: 12949224 BACKGROUND

• Nitsche MA, Liebetanz D, Lang N, Antal A, Tergau F, Paulus W. Safety criteria for transcranial direct current stimulation (tDCS) in humans. Clin Neurophysiol. 2003 Nov;114(11):2220-2; author reply 2222-3. doi: 10.1016/s1388-2457(03)00235-9. No abstract available.

  PMID: 14580622 BACKGROUND

• Fregni F, Boggio PS, Nitsche M, Bermpohl F, Antal A, Feredoes E, Marcolin MA, Rigonatti SP, Silva MT, Paulus W, Pascual-Leone A. Anodal transcranial direct current stimulation of prefrontal cortex enhances working memory. Exp Brain Res. 2005 Sep;166(1):23-30. doi: 10.1007/s00221-005-2334-6. Epub 2005 Jul 6.

  PMID: 15999258 BACKGROUND

• Kang EK, Kim DY, Paik NJ. Transcranial direct current stimulation of the left prefrontal cortex improves attention in patients with traumatic brain injury: a pilot study. J Rehabil Med. 2012 Apr;44(4):346-50. doi: 10.2340/16501977-0947.

  PMID: 22434324 BACKGROUND

• Boggio PS, Ferrucci R, Rigonatti SP, Covre P, Nitsche M, Pascual-Leone A, Fregni F. Effects of transcranial direct current stimulation on working memory in patients with Parkinson's disease. J Neurol Sci. 2006 Nov 1;249(1):31-8. doi: 10.1016/j.jns.2006.05.062. Epub 2006 Jul 14.

  PMID: 16843494 BACKGROUND

• Ferrucci R, Mameli F, Guidi I, Mrakic-Sposta S, Vergari M, Marceglia S, Cogiamanian F, Barbieri S, Scarpini E, Priori A. Transcranial direct current stimulation improves recognition memory in Alzheimer disease. Neurology. 2008 Aug 12;71(7):493-8. doi: 10.1212/01.wnl.0000317060.43722.a3. Epub 2008 Jun 4.

  PMID: 18525028 BACKGROUND

MeSH Terms

Conditions

Persistent Vegetative State; Consciousness Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Aurore Thibaut and Pr Steven Laureys
• Organization: Coma Science Group, University of Liège

athibaut@ulg.ac.be

003243662362

Study Officials

• Steven Laureys, MD, PhD

  Coma Science Group, Cyclotron Research Centre, University and University Hospital of Liège

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 27, 2012
• Study Start: January 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: December 1, 2011
• Last Updated: June 9, 2014
• Results First Posted: June 9, 2014

Record last verified: 2014-05

Locations

BE (1)