Clinical trial NCT05302362: Effect of Fixed vs. Tailored Intensity tDCS for Attention Deficit After TBI
Official title: Effect of Fixed vs. Tailored Intensity Transcranial Direct Current Stimulation for Attention Deficit After Traumatic Brain Injury: a Single Center, Prospective, Double Blind, Randomized-Controlled Clinical Trial, Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Attention Deficit
Cognitive Impairment
Keywords: traumatic brain injury
attention deficit
transcranial direct current stimulation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Rehabilitation Center, Seoul, Korea
First posted: 2022-03-31
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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:

1. Sham group and actual stimulation group will show significantly different aCPT response time after 10 tDCS sessions.
2. Within the actual stimulation group, tailored tDCS subgroup will show significantly better aCPT response time than conventional tDCS subgroup after 10 tDCS sessions.
3. Patients with EEG biomarker change will show significantly better aCPT response time than those without.

Eligibility criteria: Inclusion Criteria:

* 19 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Auditory Continuous Performance Test (aCPT) response time
timeFrame: 6 weeks
Secondary outcomes:
measure: Auditory Continuous Performance Test (aCPT) omission error, commission error
timeFrame: 6 weeks
measure: Computerized Neurocognitive Test (CNT)
timeFrame: 6 weeks
measure: Cambridge Neuropsychological Test Automated Battery (CANTAB)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Byung-Mo Oh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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