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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anodal tDCS | Device | patients received anodal tDCS (on PFDL cortex) during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Laureys, MD, PhD | Coma Science Group, Cyclotron Research Centre, University and University Hospital of Liège | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Liège | Liège | Liège | 4000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7818633 | Background | 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. | |
| 11839831 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anodal tDCS | Anodal tDCS (on DLPF cortex) first, hen 2 days of washout, then sham tDCS. |
| FG001 | Sham tDCS | Sham tDCS during first, then 2 days of washout, then anodal tDCS. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
36 patients received first the anodal stimulation and 26 received first the sham stimulation.
Each patient received both stimulation exept for 7 patients. They were excluded due to diagnosis change between the 2 stimulations.
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| ID | Title | Description |
|---|---|---|
| BG000 | Anodal tDCS First | Patients received anodal tDCS during 20 minutes. Then, washout of 2days. Then sham tDCS. |
| BG001 | Sham tDCS First | Patients received sham tDCS during 20 minutes. Then, washout of 2days. Then andoal tDCS. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and directly after the tDCS (20 minutes) |
|
From the first stimulation to one month after the end of the 2 stimulations.
We use the GOSE (Glasgow outcome scale extended) to assess a possible decrease (or inscrease) in patient status.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anodal tDCS | Patients received anodal tDCS (on DLPF cortex) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised) Anodal tDCS: patients received anodal tDCS (on PFDL cortex) during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aurore Thibaut and Pr Steven Laureys | Coma Science Group, University of Liège | 003243662362 | athibaut@ulg.ac.be |
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| ID | Term |
|---|---|
| D018458 | Persistent Vegetative State |
| D003244 | Consciousness Disorders |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| 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. |
|
| Influence of Time Since Insult on the Results |
| participants will be followed for the duration of 1 year |
| 12949224 | 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. |
| 14580622 | 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. |
| 15999258 | 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. |
| 22434324 | 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. |
| 16843494 | 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. |
| 18525028 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Sham tDCS First | Patients received sham tDCS first during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised). Then, a washout period (2days). Then anodal tDCS during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised). |
|
|
| Secondary | Influence of Diagnosis on the Results | Not Posted | participants will be followed for the duration of 1 year |
| Secondary | Influence of Etiology on the Results | Not Posted | participants will be followed for the duration of 1 year |
| Secondary | Influence of Time Since Insult on the Results | Not Posted | participants will be followed for the duration of 1 year |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | 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. 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. | 0 | 55 | 0 | 55 |
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| D014474 | Unconsciousness |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |