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

Primary Purpose

Traumatic Brain Injury, Attention Deficit, Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring traumatic brain injury, attention deficit, transcranial direct current stimulation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Experimental

Arm Label

Sham tDCS Group

Conventional tDCS Group

Tailored tDCS Group

Arm Description

Sham transcranial direct current stimulation using YMS-201B(YBrain, Daejeon, Korea); ramp-up 30sec to 1.5mA, 0mA stimulation for 19 min 30 sec.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Computerized Neurocognitive Test (CNT)
Digit span test: Digit span forward test follows the number played through the computer speaker as it is and a digit span backward test speaks in reverse. Verbal learning test: 15 target words are heard through the computer speaker, recalled in any order and the same target word is repeated five times. After listening to the target word five times, 15 new words are heard and then recalled for blocking and then the 15 target words are recalled again. Stroop test: 24 letters of "green," "blue," "yellow," and "red" and the corresponding colors are read as quickly as possible. Several tests consist of (A) reading black letters, (B) the test to read the color by presenting each color square, (C) the test to read letters that match the color of the letter, and (D) the test to read the color of the letter whose color that composes the letter does not match the letter. The response time is scored.
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. Reaction Time (RTI) Reaction Time provides assessments of motor and mental response speeds, as well as measures of movement time, reaction time, response accuracy and impulsivity. Rapid Visual Information Processing (RVP) A white box is shown in the center of the screen, inside which digits appear in a pseudo-random order, at the rate of 100 digits per minute. Participants are requested to detect target sequences of digits When the participant sees the target sequence they must respond by selecting the button in the center of the screen as quickly as possible. The level of difficulty varies with either one- or three-target sequences that the participant must watch for at the same time.

Full Information

First Posted
March 21, 2022
Last Updated
March 21, 2022
Sponsor
Seoul National University Hospital
Collaborators
National Rehabilitation Center, Seoul, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT05302362
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
National Rehabilitation Center, Seoul, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Attention Deficit, Cognitive Impairment
Keywords
traumatic brain injury, attention deficit, transcranial direct current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Prospective, Double Blind, Randomized Controlled Clinical Trial ,
Allocation
Randomized
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham tDCS Group
Arm Type
Sham Comparator
Arm Description
Sham transcranial direct current stimulation using YMS-201B(YBrain, Daejeon, Korea); ramp-up 30sec to 1.5mA, 0mA stimulation for 19 min 30 sec.
Arm Title
Conventional tDCS Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Tailored tDCS Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Intervention Description
Transcranial direct current stimulation using YMS-201B(YBrain, Daejeon, Korea)
Primary Outcome Measure Information:
Title
Auditory Continuous Performance Test (aCPT) response time
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Auditory Continuous Performance Test (aCPT) omission error, commission error
Description
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.
Time Frame
6 weeks
Title
Computerized Neurocognitive Test (CNT)
Description
Digit span test: Digit span forward test follows the number played through the computer speaker as it is and a digit span backward test speaks in reverse. Verbal learning test: 15 target words are heard through the computer speaker, recalled in any order and the same target word is repeated five times. After listening to the target word five times, 15 new words are heard and then recalled for blocking and then the 15 target words are recalled again. Stroop test: 24 letters of "green," "blue," "yellow," and "red" and the corresponding colors are read as quickly as possible. Several tests consist of (A) reading black letters, (B) the test to read the color by presenting each color square, (C) the test to read letters that match the color of the letter, and (D) the test to read the color of the letter whose color that composes the letter does not match the letter. The response time is scored.
Time Frame
6 weeks
Title
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Description
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. Reaction Time (RTI) Reaction Time provides assessments of motor and mental response speeds, as well as measures of movement time, reaction time, response accuracy and impulsivity. Rapid Visual Information Processing (RVP) A white box is shown in the center of the screen, inside which digits appear in a pseudo-random order, at the rate of 100 digits per minute. Participants are requested to detect target sequences of digits When the participant sees the target sequence they must respond by selecting the button in the center of the screen as quickly as possible. The level of difficulty varies with either one- or three-target sequences that the participant must watch for at the same time.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Youho Myong, MD
Phone
821046437618
Email
myong.youho@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byung-Mo Oh, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byung-Mo Oh, MD, PhD
Phone
82-2-2072-1358
Email
keepwiz@gmail.com
First Name & Middle Initial & Last Name & Degree
Byung-Mo Oh, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data can be shared on reasonable request
Citations:
PubMed Identifier
16983222
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.
Results Reference
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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.
Results Reference
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PubMed Identifier
15247842
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.
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19116810
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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PubMed Identifier
15758589
Citation
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Effect of Fixed vs. Tailored Intensity tDCS for Attention Deficit After TBI

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