Effect of Fixed vs. Tailored Intensity tDCS for Attention Deficit After TBI

NCT05302362 | Completed DMC

• 1 other identifier: TBI_tDCS
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury; Attention Deficit; Cognitive Impairment

Keywords

traumatic brain injury; attention deficit; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Auditory Continuous Performance Test (aCPT) omission error, commission error

  6 weeks

• Computerized Neurocognitive Test (CNT)

  6 weeks

• Cambridge Neuropsychological Test Automated Battery (CANTAB)

  6 weeks

Study Arms (3)

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.

Device: transcranial direct current stimulation

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.

Device: transcranial direct current stimulation

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.

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation DEVICE

Transcranial direct current stimulation using YMS-201B(YBrain, Daejeon, Korea)

Conventional tDCS Group; Sham tDCS Group; Tailored tDCS Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• At least 6 months since traumatic brain injury
• Cognitive disability measured by:
• A) K-MoCA score 25 or below, or B) Trail making test A \> 50.25s or B \> 142.53s

You may not qualify if:

• Infection, open wound, bleeding, skull defect, or metal plates at or near tDCS site
• history of seizure
• Language disorder
• Serious cognitive deficit with K-MoCA score below 10
• Pregnancy or possibility of pregnancy
• MRI contraindications
• Previous medical history that may affect the patient's cognitive abilities (i.e. previous stroke, hypoxic ischemic encephalopathy, schizophrenia)
• Change in dosage of the following medications within the previous 2 weeks
• rivastigmine
• donepezil
• memantine
• antiepiletic medications

Sponsors & Collaborators

• Seoul National University Hospital: lead
• National Rehabilitation Center, Seoul, Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (14)

• 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.

  PMID: 16983222 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.

  PMID: 32859061 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.

  PMID: 15247842 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.

  PMID: 19116810 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.

  PMID: 15758589 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

• 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.

  PMID: 30926291 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.

  PMID: 18977813 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.

  PMID: 21840288 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.

  PMID: 16817194 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

• 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.

  PMID: 20870863 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.

  PMID: 16499758 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.

  PMID: 21885255 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Attention Deficit Disorder with Hyperactivity; Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Byung-Mo Oh, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Prospective, Double Blind, Randomized Controlled Clinical Trial ,
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: March 14, 2022
• Primary Completion: July 20, 2023
• Study Completion: August 18, 2023
• Last Updated: April 17, 2024

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)