Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness (tDCS in DOC)
Primary Purpose
Vegetative State, Minimally Conscious State, Disorders of Consciousness
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Anodal tDCS
sham tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Vegetative State focused on measuring vegetative state, minimally conscious state, disorders of consciousness, transcranial direct current stimulation
Eligibility Criteria
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)
Sites / Locations
- University Hospital of Liège
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Anodal tDCS
sham tDCS
Arm Description
Patients received anodal tDCS (on DLPF cortex) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Influence of Diagnosis on the Results
Influence of Etiology on the Results
Influence of Time Since Insult on the Results
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01673126
Brief Title
Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness
Acronym
tDCS in DOC
Official Title
Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness: a Sham-controlled Randomised Double Blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vegetative State, Minimally Conscious State, Disorders of Consciousness
Keywords
vegetative state, minimally conscious state, disorders of consciousness, transcranial direct current stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anodal tDCS
Arm Type
Active Comparator
Arm Description
Patients received anodal tDCS (on DLPF cortex) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
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
Intervention Name(s)
Anodal tDCS
Intervention Description
patients received anodal tDCS (on PFDL cortex) during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised)
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
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 Outcome Measure Information:
Title
Change in CRS-R Total Scores
Description
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.
Time Frame
Baseline and directly after the tDCS (20 minutes)
Secondary Outcome Measure Information:
Title
Influence of Diagnosis on the Results
Time Frame
participants will be followed for the duration of 1 year
Title
Influence of Etiology on the Results
Time Frame
participants will be followed for the duration of 1 year
Title
Influence of Time Since Insult on the Results
Time Frame
participants will be followed for the duration of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Laureys, MD, PhD
Organizational Affiliation
Coma Science Group, Cyclotron Research Centre, University and University Hospital of Liège
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital of Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
7818633
Citation
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.
Results Reference
background
PubMed Identifier
11839831
Citation
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.
Results Reference
background
PubMed Identifier
12949224
Citation
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.
Results Reference
background
PubMed Identifier
14580622
Citation
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.
Results Reference
background
PubMed Identifier
15999258
Citation
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.
Results Reference
background
PubMed Identifier
22434324
Citation
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.
Results Reference
background
PubMed Identifier
16843494
Citation
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.
Results Reference
background
PubMed Identifier
18525028
Citation
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.
Results Reference
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Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness
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