Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Rehabilitation Center, Seoul, Korea | OTHER_GOV |
Not provided
Not provided
Not provided
Traumatic brain injury (TBI) is an important global health concern. Recently, advances in neurocritical care have led to an increase in the number of recovering TBI patients, and concomittantly in the incidence of complications of TBI. One of the most important sequalae of TBI is cognitive deficit, for which multimodal rehabilitation approach is indicated. Transcranial direct current stimulation (tDCS) is a promising treatment strategy for post-TBI cognitive deficits. However, a standardized tailored tDCS protocol is yet to be established for TBI patients. Therefore, this trial aims to 1) the efficacy of tDCS on post-TBI cognitive deficits, and 2) and optimized protocol of tDCS on post-TBI cognitive deficits via a three-arm double-blind, randomized controlled trial.
Traumatic brain injury (TBI) is an important global health concern. It is estimated that about 70 million individuals will suffer a traumatic brain injury (TBI) each year. Serious TBIs for hospitalization or death is at least 10 million annually. In 2006, Langlois et al reported that, 50,000 patients die directly from or complications related to TBI in the united states alone, and at least 5.3 million Americans suffer from long-term disabilities related to TBI.
Recently, advances in neurocritical care have led to an increase in the number of severe TBI patients recovering cognitive and physical function, eventually returning to independent life.
With the rising recovery rate of TBI patients, the number of complications of TBI is also rising. One of the most common sequalae of TBI is cognitive deficit. In 2004, Whiteneck et al reported that about 65% of patients who experienced moderate to severe TBI suffer from long-term cognitive deficit. Mild TBI patients show fewer and lighter symptoms of cognitive deficit. However, about 15% of patients suffer from persisting cognitive, emotional, behavioral, and physical disabilities after one year (Roe et al. Disabil Rehabil. 2009).
Common symptoms of post-TBI cognitive deficit are attention deficit, memory loss, and impaired cognitive proceessing (Salmond et al. Curr Opin Crit Care. 2005). Current treatment strategy of post-TBI cognitive rehabilitation constitute multimodal approach including "conventional" occupational therapy, computerized neurocognitive training (CNT), pharmacotherapy, and physical medicine.
Transcranial direct current stimulation (tDCS) is a treatment approach where direct current is applied transcranially, aiming to modulate local neuronal excitability. Previous researches have established that repeated tDCS is safe, cost-effective, and easily administered to various neurological disorders including TBI, stroke, Parkinsonism, Alzheimer's dementia, and multiple sclerosis.
Although cognitive improvements are reported, a standardized protocol of tDCS for TBI patients is yet to be established (Kang, J Korean Neurol Assoc. 2017). The repertoire of researches that studies the efficacy of tDCS on post-TBI cognitive deficits is limited, and further study is warranted to establish standardized protocol (Ulam et al. Clinical Neurophysiology 2015; Kang et al. Journal of Rehabilitation Medicine 2012; Sacco et al. Front. Behav. Neurosci. 2016; Lesiank et al. J Head Trauma Rehabil. 2014; Rushby et al. Neuropsych Rehabil 2020; Motes et al J. Neurotrauma 2020).
This trial aims to determine 1) the efficacy of tDCS on post-TBI cognitive deficits, and 2) and optimized protocol of tDCS on post-TBI cognitive deficits via a three-arm double-blind, randomized controlled trial. The hypotheses of this experiment are as follow:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham tDCS Group | Sham Comparator | Sham transcranial direct current stimulation using YMS-201B(YBrain, Daejeon, Korea); ramp-up 30sec to 1.5mA, 0mA stimulation for 19 min 30 sec. |
|
| Conventional tDCS Group | Active Comparator | Transcranial direct current stimulation using YMS-201B(YBrain, Daejeon, Korea); ramp-up 30sec to 1.5mA, continuous 1.5mA stimulation for 19 minutes, ramp-down 30sec to 0mA. |
|
| Tailored tDCS Group | Experimental | Transcranial direct current stimulation using YMS-201B(YBrain, Daejeon, Korea); ramp-up 30sec to 2.0mA, continuous 2.0mA stimulation for 19 minutes, ramp-down 30sec to 0mA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation | Device | Transcranial direct current stimulation using YMS-201B(YBrain, Daejeon, Korea) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Auditory Continuous Performance Test (aCPT) response time | The Auditory Continuous Performance Test (ACPT) screens for auditory attention deficits. In the test, patients are told that they will see or hear the numbers "1" or "2" and that they are to click the mouse when presented with a visual or auditory "1" and inhibit clicking when presented with a "2". The task is made more challenging by the shifting of modalities between the visual and auditory stimuli. Data are provided for over-all attentional functioning and response control, as well as separate visual and auditory attention and response control. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Auditory Continuous Performance Test (aCPT) omission error, commission error | The Auditory Continuous Performance Test (ACPT) screens for auditory attention deficits. In the test, patients are told that they will see or hear the numbers "1" or "2" and that they are to click the mouse when presented with a visual or auditory "1" and inhibit clicking when presented with a "2". The task is made more challenging by the shifting of modalities between the visual and auditory stimuli. Data are provided for over-all attentional functioning and response control, as well as separate visual and auditory attention and response control. |
Not provided
Inclusion Criteria:
A) K-MoCA score 25 or below, or B) Trail making test A > 50.25s or B > 142.53s
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Byung-Mo Oh, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16983222 | Background | Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8. doi: 10.1097/00001199-200609000-00001. | |
| 32859061 | Background | Kim HK, Leigh JH, Lee YS, Choi Y, Kim Y, Kim JE, Cho WS, Seo HG, Oh BM. Decreasing Incidence and Mortality in Traumatic Brain Injury in Korea, 2008-2017: A Population-Based Longitudinal Study. Int J Environ Res Public Health. 2020 Aug 26;17(17):6197. doi: 10.3390/ijerph17176197. |
Not provided
Not provided
Individual participant data can be shared on reasonable request
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
Not provided
Not provided
Not provided
Not provided
Not provided
Prospective, Double Blind, Randomized Controlled Clinical Trial ,
| 6 weeks |
| Computerized Neurocognitive Test (CNT) |
| 6 weeks |
| Cambridge Neuropsychological Test Automated Battery (CANTAB) | CANTAB tests changes in neuropsychological performance and include tests of working memory, learning and executive function; visual, verbal and episodic memory; attention, information processing and reaction time; social and emotion recognition, decision making and response control.
| 6 weeks |
| 15247842 | Background | Whiteneck GG, Gerhart KA, Cusick CP. Identifying environmental factors that influence the outcomes of people with traumatic brain injury. J Head Trauma Rehabil. 2004 May-Jun;19(3):191-204. doi: 10.1097/00001199-200405000-00001. |
| 19116810 | Background | Roe C, Sveen U, Alvsaker K, Bautz-Holter E. Post-concussion symptoms after mild traumatic brain injury: influence of demographic factors and injury severity in a 1-year cohort study. Disabil Rehabil. 2009;31(15):1235-43. doi: 10.1080/09638280802532720. |
| 15758589 | Background | Salmond CH, Sahakian BJ. Cognitive outcome in traumatic brain injury survivors. Curr Opin Crit Care. 2005 Apr;11(2):111-6. doi: 10.1097/01.ccx.0000155358.31983.37. |
| 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. |
| 30926291 | Background | Cicerone KD, Goldin Y, Ganci K, Rosenbaum A, Wethe JV, Langenbahn DM, Malec JF, Bergquist TF, Kingsley K, Nagele D, Trexler L, Fraas M, Bogdanova Y, Harley JP. Evidence-Based Cognitive Rehabilitation: Systematic Review of the Literature From 2009 Through 2014. Arch Phys Med Rehabil. 2019 Aug;100(8):1515-1533. doi: 10.1016/j.apmr.2019.02.011. Epub 2019 Mar 26. |
| 18977813 | Background | Boggio PS, Khoury LP, Martins DC, Martins OE, de Macedo EC, Fregni F. Temporal cortex direct current stimulation enhances performance on a visual recognition memory task in Alzheimer disease. J Neurol Neurosurg Psychiatry. 2009 Apr;80(4):444-7. doi: 10.1136/jnnp.2007.141853. Epub 2008 Oct 31. |
| 21840288 | Background | Boggio PS, Ferrucci R, Mameli F, Martins D, Martins O, Vergari M, Tadini L, Scarpini E, Fregni F, Priori A. Prolonged visual memory enhancement after direct current stimulation in Alzheimer's disease. Brain Stimul. 2012 Jul;5(3):223-230. doi: 10.1016/j.brs.2011.06.006. Epub 2011 Jul 27. |
| 16817194 | Background | Fregni F, Boggio PS, Santos MC, Lima M, Vieira AL, Rigonatti SP, Silva MT, Barbosa ER, Nitsche MA, Pascual-Leone A. Noninvasive cortical stimulation with transcranial direct current stimulation in Parkinson's disease. Mov Disord. 2006 Oct;21(10):1693-702. doi: 10.1002/mds.21012. |
| 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. |
| 20870863 | Background | Benninger DH, Lomarev M, Lopez G, Wassermann EM, Li X, Considine E, Hallett M. Transcranial direct current stimulation for the treatment of Parkinson's disease. J Neurol Neurosurg Psychiatry. 2010 Oct;81(10):1105-11. doi: 10.1136/jnnp.2009.202556. |
| 16499758 | Background | Fregni F, Thome-Souza S, Nitsche MA, Freedman SD, Valente KD, Pascual-Leone A. A controlled clinical trial of cathodal DC polarization in patients with refractory epilepsy. Epilepsia. 2006 Feb;47(2):335-42. doi: 10.1111/j.1528-1167.2006.00426.x. |
| 21885255 | Background | Varga ET, Terney D, Atkins MD, Nikanorova M, Jeppesen DS, Uldall P, Hjalgrim H, Beniczky S. Transcranial direct current stimulation in refractory continuous spikes and waves during slow sleep: a controlled study. Epilepsy Res. 2011 Nov;97(1-2):142-5. doi: 10.1016/j.eplepsyres.2011.07.016. Epub 2011 Aug 31. |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |