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tDCS and Cognitive Training in Active Duty Service Members With Mild TBI: A Pilot Study

Primary Purpose

Brain Concussion, Brain Trauma, Attention Concentration Difficulty

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
active tDCS and cognitive training intervention
sham tDCS and cognitive training intervention
Sponsored by
United States Naval Medical Center, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Concussion focused on measuring military health, brain stimulation, cognitive training, cognitive rehabilitation

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • (1) Have a remote history mild traumatic brain injury as defined by the VA/DoD clinical practice guidelines(The Management of Concussion/mTBI Working Group, 2016) that is >/= 6 months, and report moderate severity neurocognitive symptoms related to attention, concentration, working memory, or memory based on NSI scores and self-report.
  • (2) Are between the ages of 18-55.
  • (3) Are stable on any medications for at least 2 weeks at the baseline visit (Visit #1).

Exclusion Criteria:

  • (1) Have a history of seizures or epilepsy.
  • (2) Have a history of ECT or cortical energy exposure within the past 12 months, including participation in any other neuromodulation studies.
  • (3) Have current stimulant dependence.
  • (4) Have a diagnosis of intellectual disability or pervasive developmental disorder (i.e. premorbid IQ less than or equal to 70).
  • (5) Have any medical condition or treatment other than mild TBI (e.g. stroke, tumor, HIV, moderate-severe TBI), with significant neurological disorder or insults that, based on the Principal Investigator's judgement, would impact risk.
  • (6) Diagnosed with current active psychosis or mania.
  • (7) Have metallic cranial plates/screws or implanted device,
  • (8) Have eczema on scalp or other scalp lesions or skin disorders that may become irritated by stimulation.
  • (9) Pregnant individuals and individuals with ferromagnetic metal in their body that would prohibit them from being safe in the MRI will not be excluded from the overall study, but will be excluded from the optional MRI.

Sites / Locations

  • Naval Medical Center San DiegoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

Based on previous studies targeting working memory, focality of current delivery, and comfort and tolerance levels, (Paulo S. Boggio et al., 2006; Hill et al., 2016; Hoy et al., 2013; Teo, Hoy, Daskalakis, & Fitzgerald, 2011), we will use a 2 mA current administered via two circular carbon rubber core electrodes in saline-soaked surface sponges (25 cm2), placed in a neoprene headcap with marked locations based on the 10-10 EEG system. The anodal stimulating electrode will be at location F3, over left dorsolateral prefrontal cortex (DLPFC) and the cathodal electrode at location F4, over right DLPFC. Two reference electrodes, CMS and DRL, will be attached to the EarClip and applied to the earlobe with conductive gel. Before each training session, the impedance of the electrodes will be checked and verified to be ≤15 KOhm. Additionally, the stimulation will be terminated if the impedance of the electrodes is > 20 KOhm. The current and impedance will be recorded for every session.

For sham stimulation, the electrodes will be placed at the same positions as for active stimulation (F3 and F4). After an initial ramp-up period of 30 seconds, stimulation fades out over a period of 30 seconds. Additionally, at the end of the sham stimulation period, stimulation will fade in over a period of 30 seconds and then end with a final 30 second ramp-down period. Participants will feel the initial itching sensation associated with tDCS and experience the ramp-down period at the end of the sham stimulation period but will receive no active current during the rest of the sham stimulation period. This method of sham stimulation has been shown to be reliable (Gandiga et al., 2006). Before each training session, the impedance of the electrodes will be checked and verified to be ≤15 KOhm. Additionally, the stimulation will be terminated if the impedance of the electrodes is > 20 KOhm. The current and impedance will be recorded for every session.

Outcomes

Primary Outcome Measures

Symbol Digit Modalities Test (SDMT)
Standardized neuropsychological assessment measure of visual attention and working memory
Symbol Digit Modalities Test (SDMT)
Standardized neuropsychological assessment measure of visual attention and working memory
Symbol Digit Modalities Test (SDMT)
Standardized neuropsychological assessment measure of visual attention and working memory
Neuropsychological Assessment Battery (NAB) Attention Module
Standardized neuropsychological assessment consisting of 4 subtests to assess visual and auditory attention, working memory, and scanning.
Neuropsychological Assessment Battery (NAB) Attention Module
Standardized neuropsychological assessment consisting of 4 subtests to assess visual and auditory attention, working memory, and scanning.
Neuropsychological Assessment Battery (NAB) Attention Module
Standardized neuropsychological assessment consisting of 4 subtests to assess visual and auditory attention, working memory, and scanning.
Electroencephalogram (EEG)
EEG will be collected to assess neural dynamics during rest and during performance of generalization tasks. The neural dynamics to be assessed include functional connectivity, mean ERP amplitude, and spectral power of delta, theta, alpha, beta, and gamma frequency bands.
Electroencephalogram (EEG)
EEG will be collected to assess neural dynamics during rest and during performance of generalization tasks. The neural dynamics to be assessed include functional connectivity, mean ERP amplitude, and spectral power of delta, theta, alpha, beta, and gamma frequency bands.
Electroencephalogram (EEG)
EEG will be collected to assess neural dynamics during rest and during performance of generalization tasks. The neural dynamics to be assessed include functional connectivity, mean ERP amplitude, and spectral power of delta, theta, alpha, beta, and gamma frequency bands.
Neurobehavioral Symptom Inventory (NSI)
A measure of common post-concussive symptoms rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of symptoms and high scores corresponding to more severe incidence of symptoms.
Neurobehavioral Symptom Inventory (NSI)
A measure of common post-concussive symptoms rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of symptoms and high scores corresponding to more severe incidence of symptoms.
Neurobehavioral Symptom Inventory (NSI)
A measure of common post-concussive symptoms rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of symptoms and high scores corresponding to more severe incidence of symptoms.
Magnetic Resonance Imaging (MRI) w/out contrast (optional)
Medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in your body. Mean white matter and CSF signals across time are calculated for each participant. Additionally, time courses for regions of interest are also extracted.

Secondary Outcome Measures

NIH Toolbox Quality of Life Assessment (NeuroQoL)
Questionnaire to assess quality of life with regard to cognitive, social, emotional, and behavioral abilities rated on a 5-point Likert scale (1-5); with low scores corresponding to mild to no impairment in these abilities and high scores corresponding to more severe impairment in these abilities.
NIH Toolbox Quality of Life Assessment (NeuroQoL)
Questionnaire to assess quality of life with regard to cognitive, social, emotional, and behavioral abilities rated on a 5-point Likert scale (1-5); with low scores corresponding to mild to no impairment in these abilities and high scores corresponding to more severe impairment in these abilities.
NIH Toolbox Quality of Life Assessment (NeuroQoL)
Questionnaire to assess quality of life with regard to cognitive, social, emotional, and behavioral abilities rated on a 5-point Likert scale (1-5); with low scores corresponding to mild to no impairment in these abilities and high scores corresponding to more severe impairment in these abilities.
Insomnia Severity Index (ISI)
Measure of insomnia severity rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of insomnia and high scores corresponding to more severe incidences of insomnia.
Insomnia Severity Index (ISI)
Measure of insomnia severity rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of insomnia and high scores corresponding to more severe incidences of insomnia.
Insomnia Severity Index (ISI)
Measure of insomnia severity rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of insomnia and high scores corresponding to more severe incidences of insomnia.
Fusion Task
Multi-modal assessment of brain function including EEG and eye tracking. The EEG measures to be assessed include functional connectivity, mean ERP amplitude, and spectral power of delta, theta, alpha, beta, and gamma frequency bands. Other outcome measures to be assessed include saccadic response time latency, saccadic response time consistency, manual response time latency, manual response time consistency, and 1-back total score.
Fusion Task
Multi-modal assessment of brain function including EEG and eye tracking. The EEG measures to be assessed include functional connectivity, mean ERP amplitude, and spectral power of delta, theta, alpha, beta, and gamma frequency bands. Other outcome measures to be assessed include saccadic response time latency, saccadic response time consistency, manual response time latency, manual response time consistency, and 1-back total score.
Fusion Task
Multi-modal assessment of brain function including EEG and eye tracking. The EEG measures to be assessed include functional connectivity, mean ERP amplitude, and spectral power of delta, theta, alpha, beta, and gamma frequency bands. Other outcome measures to be assessed include saccadic response time latency, saccadic response time consistency, manual response time latency, manual response time consistency, and 1-back total score.
tDCS Symptom Rating Questionnaire (SRQ)
Questionnaire to assess pre-post tDCS symptom rating, rated on a 4-point Likert scale (0-3); with low scores corresponding to mild or no incidence of symptoms and high scores corresponding to severe incidence of symptoms.
BrainHQ Task Load Index (TLX)
Subjective workload assessment of level of effort, mental demand, frustration, and performance during cognitive training, rated on a 10-point Likert scale (1-10); with low scores corresponding to less effort or mental demand and high scores corresponding to more effort or mental demand.

Full Information

First Posted
September 8, 2020
Last Updated
September 26, 2022
Sponsor
United States Naval Medical Center, San Diego
Collaborators
The Defense and Veterans Brain Injury Center
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1. Study Identification

Unique Protocol Identification Number
NCT04925453
Brief Title
tDCS and Cognitive Training in Active Duty Service Members With Mild TBI: A Pilot Study
Official Title
Transcranial Direct Current Stimulation (tDCS) and Cognitive Training to Improve Concentration and Working Memory in Active Duty Service Members Following Mild Traumatic Brain Injury (mTBI): A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Naval Medical Center, San Diego
Collaborators
The Defense and Veterans Brain Injury Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The proposed study will evaluate a new approach to cognitive rehabilitation of mild traumatic brain injury (mTBI) using a brain stimulation technique called transcranial direct current stimulation (tDCS). Specifically, we will investigate how tDCS combined with cognitive training improves deficits to attention and working memory in Active Duty Service Members with a history of mild traumatic brain injury (TBI). Measures of attention-related brain activity, neurocognitive assessments, and self-reported clinical outcomes will be used to determine effects of tDCS vs. sham tDCS when paired with a cognitive training intervention. By doing this study, we hope to find a reliable, noninvasive, and efficient method of treating mild TBI cognitive symptoms.
Detailed Description
Objectives: The proposed study will evaluate a new approach to cognitive rehabilitation of mild traumatic brain injury (mTBI) using a brain stimulation technique called transcranial direct current stimulation (tDCS). Specifically, we will investigate how tDCS combined with cognitive training improves deficits to attention and working memory in Active Duty Service Members with a history of mTBI. Measures of attention-related brain activity, neurocognitive assessments, and self-reported clinical outcomes will be used to determine effects of tDCS vs. sham tDCS when paired with a cognitive training intervention. By doing this study, we hope to find a reliable, noninvasive, and efficient method of treating mild TBI cognitive symptoms. Research Plan and Methods: This is a double-blind, randomized, placebo (sham) controlled pilot study. We will recruit 60 Active Duty Service Members who are receiving outpatient services at Naval Medical Center San Diego, with a history of mTBI and reported neurocognitive symptoms related to attention, working memory, and related cognitive processes. Intake will involve a full pre-assessment of symptoms, neurocognitive performance, and an optional MRI scan. Participants will be randomized to either active or sham tDCS. Training/tDCS sessions will occur daily over five consecutive days. Random permuted blocks will be used to ensure exactly equal treatment numbers at certain equally spaced points in the sequence of patient assignment. Post-intervention assessment will include another assessment of symptoms, neurocognitive performance, and an optional MRI scan. Participants will complete assessments of symptoms and neurocognitive performance six-weeks following the post-intervention assessment. Clinical Relevance to TBICoE/Navy Medicine: Aspects of this study will provide insight into a major research gap highlighted in the mission of the Defense and Veterans Brain Injury Center, specifically in identifying/ developing innovative treatments/interventions which promote patient recovery and/or mitigate symptoms after mTBI. Novel, well-tolerated, neuroplasticity-based interventions that can improve attention, concentration, and working memory by targeting the underlying neural dysfunction are needed to improve outcomes and quality of life for Active Duty Service Members affected by neurocognitive weakness and dysfunction following mTBI. If tDCS proves successful in reducing TBI-related symptoms, improving cognition, or enhancing functional recovery, this non-invasive intervention could be implemented within various DoD and VA settings, enhancing recovery, improving quality of life, and bolstering occupational performance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Concussion, Brain Trauma, Attention Concentration Difficulty, Brain Injuries, Brain Injuries, Traumatic, Neurocognitive Dysfunction, Attention Impaired, Memory Impairment, Mild Traumatic Brain Injury, Mild Cognitive Impairment
Keywords
military health, brain stimulation, cognitive training, cognitive rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a double-blind, randomized, placebo (sham) controlled pilot study.
Masking
ParticipantCare ProviderInvestigator
Masking Description
The tDCS unit software has a double-blind selection, blinding all study members, care providers, and participants until blinds are broken.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Experimental
Arm Description
Based on previous studies targeting working memory, focality of current delivery, and comfort and tolerance levels, (Paulo S. Boggio et al., 2006; Hill et al., 2016; Hoy et al., 2013; Teo, Hoy, Daskalakis, & Fitzgerald, 2011), we will use a 2 mA current administered via two circular carbon rubber core electrodes in saline-soaked surface sponges (25 cm2), placed in a neoprene headcap with marked locations based on the 10-10 EEG system. The anodal stimulating electrode will be at location F3, over left dorsolateral prefrontal cortex (DLPFC) and the cathodal electrode at location F4, over right DLPFC. Two reference electrodes, CMS and DRL, will be attached to the EarClip and applied to the earlobe with conductive gel. Before each training session, the impedance of the electrodes will be checked and verified to be ≤15 KOhm. Additionally, the stimulation will be terminated if the impedance of the electrodes is > 20 KOhm. The current and impedance will be recorded for every session.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
For sham stimulation, the electrodes will be placed at the same positions as for active stimulation (F3 and F4). After an initial ramp-up period of 30 seconds, stimulation fades out over a period of 30 seconds. Additionally, at the end of the sham stimulation period, stimulation will fade in over a period of 30 seconds and then end with a final 30 second ramp-down period. Participants will feel the initial itching sensation associated with tDCS and experience the ramp-down period at the end of the sham stimulation period but will receive no active current during the rest of the sham stimulation period. This method of sham stimulation has been shown to be reliable (Gandiga et al., 2006). Before each training session, the impedance of the electrodes will be checked and verified to be ≤15 KOhm. Additionally, the stimulation will be terminated if the impedance of the electrodes is > 20 KOhm. The current and impedance will be recorded for every session.
Intervention Type
Combination Product
Intervention Name(s)
active tDCS and cognitive training intervention
Other Intervention Name(s)
intervention group, active group
Intervention Description
Intervention sessions will occur during Visits 2-6. Cognitive training will occur concurrently with tDCS in both the active and sham tDCS groups. Over each 46-minute daily training period, 4 of 5 BrainHQ training tasks will be performed for approximately 11 minutes in a randomly selected order. Order of task presentation will be randomized each session. Stimulation sequences will occur in the first 13 minutes (shut off: Minute 13) of the session and the last 13 minutes of the session (turn on: Minute 33). The Symptom Rating Questionnaire (SRQ) will be asked before and after stimulation to assess for any side-effects. The BrainHQ Task Load Index (TLX) will be administered at the end of each intervention session. At the end of Intervention Session 3, subjects will be given a Blinding Questionnaire which asks whether they thought they received active or sham treatment.
Intervention Type
Combination Product
Intervention Name(s)
sham tDCS and cognitive training intervention
Other Intervention Name(s)
fake tDCS group, placebo group, sham group
Intervention Description
Intervention sessions will occur during Visits 2-6. Cognitive training will occur concurrently with tDCS in both the active and sham tDCS groups. Over each 46-minute daily training period, 4 of 5 BrainHQ training tasks will be performed for approximately 11 minutes in a randomly selected order. Order of task presentation will be randomized each session. Stimulation sequences will occur in the first and last 13 minutes of the session. For sham stimulation, the electrodes will be placed at the same positions as for active stimulation, but current will be ramped down immediately after the initial 30s ramp up period. The Symptom Rating Questionnaire (SRQ) will be asked before and after stimulation to assess for any side-effects. The BrainHQ Task Load Index (TLX) will be administered at the end of each intervention session. At the end of Intervention Session 3, subjects will be given a Blinding Questionnaire which asks whether they thought they received active or sham treatment.
Primary Outcome Measure Information:
Title
Symbol Digit Modalities Test (SDMT)
Description
Standardized neuropsychological assessment measure of visual attention and working memory
Time Frame
Change from Baseline SDMT at 1 week after the intervention.
Title
Symbol Digit Modalities Test (SDMT)
Description
Standardized neuropsychological assessment measure of visual attention and working memory
Time Frame
Change from Baseline SDMT at 6 weeks after the intervention.
Title
Symbol Digit Modalities Test (SDMT)
Description
Standardized neuropsychological assessment measure of visual attention and working memory
Time Frame
Change from 1 week post-intervention SDMT at 6 weeks after the intervention.
Title
Neuropsychological Assessment Battery (NAB) Attention Module
Description
Standardized neuropsychological assessment consisting of 4 subtests to assess visual and auditory attention, working memory, and scanning.
Time Frame
Change from Baseline NAB Attention Module at 1 week after the intervention.
Title
Neuropsychological Assessment Battery (NAB) Attention Module
Description
Standardized neuropsychological assessment consisting of 4 subtests to assess visual and auditory attention, working memory, and scanning.
Time Frame
Change from Baseline NAB Attention Module at 6 weeks after the intervention.
Title
Neuropsychological Assessment Battery (NAB) Attention Module
Description
Standardized neuropsychological assessment consisting of 4 subtests to assess visual and auditory attention, working memory, and scanning.
Time Frame
Change from 1 week post-intervention NAB Attention Module at 6 weeks after the intervention.
Title
Electroencephalogram (EEG)
Description
EEG will be collected to assess neural dynamics during rest and during performance of generalization tasks. The neural dynamics to be assessed include functional connectivity, mean ERP amplitude, and spectral power of delta, theta, alpha, beta, and gamma frequency bands.
Time Frame
Change from Baseline EEG at 1 week after the intervention.
Title
Electroencephalogram (EEG)
Description
EEG will be collected to assess neural dynamics during rest and during performance of generalization tasks. The neural dynamics to be assessed include functional connectivity, mean ERP amplitude, and spectral power of delta, theta, alpha, beta, and gamma frequency bands.
Time Frame
Change from Baseline EEG at 6 weeks after the intervention.
Title
Electroencephalogram (EEG)
Description
EEG will be collected to assess neural dynamics during rest and during performance of generalization tasks. The neural dynamics to be assessed include functional connectivity, mean ERP amplitude, and spectral power of delta, theta, alpha, beta, and gamma frequency bands.
Time Frame
Change from 1 week post-intervention EEG at 6 weeks after the intervention.
Title
Neurobehavioral Symptom Inventory (NSI)
Description
A measure of common post-concussive symptoms rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of symptoms and high scores corresponding to more severe incidence of symptoms.
Time Frame
Change from Baseline NSI at 1 week after the intervention.
Title
Neurobehavioral Symptom Inventory (NSI)
Description
A measure of common post-concussive symptoms rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of symptoms and high scores corresponding to more severe incidence of symptoms.
Time Frame
Change from Baseline NSI at 6 weeks after the intervention.
Title
Neurobehavioral Symptom Inventory (NSI)
Description
A measure of common post-concussive symptoms rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of symptoms and high scores corresponding to more severe incidence of symptoms.
Time Frame
Change from 1 week post-intervention NSI at 6 weeks after the intervention.
Title
Magnetic Resonance Imaging (MRI) w/out contrast (optional)
Description
Medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in your body. Mean white matter and CSF signals across time are calculated for each participant. Additionally, time courses for regions of interest are also extracted.
Time Frame
Change from Baseline MRI at 1 week after the intervention.
Secondary Outcome Measure Information:
Title
NIH Toolbox Quality of Life Assessment (NeuroQoL)
Description
Questionnaire to assess quality of life with regard to cognitive, social, emotional, and behavioral abilities rated on a 5-point Likert scale (1-5); with low scores corresponding to mild to no impairment in these abilities and high scores corresponding to more severe impairment in these abilities.
Time Frame
Change from Baseline NeuroQoL at 1 week after the intervention.
Title
NIH Toolbox Quality of Life Assessment (NeuroQoL)
Description
Questionnaire to assess quality of life with regard to cognitive, social, emotional, and behavioral abilities rated on a 5-point Likert scale (1-5); with low scores corresponding to mild to no impairment in these abilities and high scores corresponding to more severe impairment in these abilities.
Time Frame
Change from Baseline NeuroQoL at 6 weeks after the intervention.
Title
NIH Toolbox Quality of Life Assessment (NeuroQoL)
Description
Questionnaire to assess quality of life with regard to cognitive, social, emotional, and behavioral abilities rated on a 5-point Likert scale (1-5); with low scores corresponding to mild to no impairment in these abilities and high scores corresponding to more severe impairment in these abilities.
Time Frame
Change from 1 week post-intervention NeuroQoL at 6 weeks after the intervention.
Title
Insomnia Severity Index (ISI)
Description
Measure of insomnia severity rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of insomnia and high scores corresponding to more severe incidences of insomnia.
Time Frame
Change from Baseline ISI at 1 week after the intervention.
Title
Insomnia Severity Index (ISI)
Description
Measure of insomnia severity rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of insomnia and high scores corresponding to more severe incidences of insomnia.
Time Frame
Change from Baseline ISI at 6 weeks after the intervention.
Title
Insomnia Severity Index (ISI)
Description
Measure of insomnia severity rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of insomnia and high scores corresponding to more severe incidences of insomnia.
Time Frame
Change from 1 week post-intervention ISI at 6 weeks after the intervention.
Title
Fusion Task
Description
Multi-modal assessment of brain function including EEG and eye tracking. The EEG measures to be assessed include functional connectivity, mean ERP amplitude, and spectral power of delta, theta, alpha, beta, and gamma frequency bands. Other outcome measures to be assessed include saccadic response time latency, saccadic response time consistency, manual response time latency, manual response time consistency, and 1-back total score.
Time Frame
Change from Baseline Fusion task at 1 week after the intervention.
Title
Fusion Task
Description
Multi-modal assessment of brain function including EEG and eye tracking. The EEG measures to be assessed include functional connectivity, mean ERP amplitude, and spectral power of delta, theta, alpha, beta, and gamma frequency bands. Other outcome measures to be assessed include saccadic response time latency, saccadic response time consistency, manual response time latency, manual response time consistency, and 1-back total score.
Time Frame
Change from Baseline Fusion task at 6 weeks after the intervention.
Title
Fusion Task
Description
Multi-modal assessment of brain function including EEG and eye tracking. The EEG measures to be assessed include functional connectivity, mean ERP amplitude, and spectral power of delta, theta, alpha, beta, and gamma frequency bands. Other outcome measures to be assessed include saccadic response time latency, saccadic response time consistency, manual response time latency, manual response time consistency, and 1-back total score.
Time Frame
Change from 1 week post-intervention Fusion task at 6 weeks after the intervention.
Title
tDCS Symptom Rating Questionnaire (SRQ)
Description
Questionnaire to assess pre-post tDCS symptom rating, rated on a 4-point Likert scale (0-3); with low scores corresponding to mild or no incidence of symptoms and high scores corresponding to severe incidence of symptoms.
Time Frame
Change from pre-intervention SRQ at post-intervention.
Title
BrainHQ Task Load Index (TLX)
Description
Subjective workload assessment of level of effort, mental demand, frustration, and performance during cognitive training, rated on a 10-point Likert scale (1-10); with low scores corresponding to less effort or mental demand and high scores corresponding to more effort or mental demand.
Time Frame
Immediately after the intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (1) Have a remote history mild traumatic brain injury as defined by the VA/DoD clinical practice guidelines(The Management of Concussion/mTBI Working Group, 2016) that is >/= 6 months, and report moderate severity neurocognitive symptoms related to attention, concentration, working memory, or memory based on NSI scores and self-report. (2) Are between the ages of 18-55. (3) Are stable on any medications for at least 2 weeks at the baseline visit (Visit #1). Exclusion Criteria: (1) Have a history of seizures or epilepsy. (2) Have a history of ECT or cortical energy exposure within the past 12 months, including participation in any other neuromodulation studies. (3) Have current stimulant dependence. (4) Have a diagnosis of intellectual disability or pervasive developmental disorder (i.e. premorbid IQ less than or equal to 70). (5) Have any medical condition or treatment other than mild TBI (e.g. stroke, tumor, HIV, moderate-severe TBI), with significant neurological disorder or insults that, based on the Principal Investigator's judgement, would impact risk. (6) Diagnosed with current active psychosis or mania. (7) Have metallic cranial plates/screws or implanted device, (8) Have eczema on scalp or other scalp lesions or skin disorders that may become irritated by stimulation. (9) Pregnant individuals and individuals with ferromagnetic metal in their body that would prohibit them from being safe in the MRI will not be excluded from the overall study, but will be excluded from the optional MRI.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lars D Hungerford, PhD
Phone
619.532.5715
Email
lars.d.hungerford.ctr@mail.mil
First Name & Middle Initial & Last Name or Official Title & Degree
Angelica (Dilay) Aguirre, MPH
Phone
619-532-6132
Email
angelica.d.aguirre2.ctr@mail.mil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars D Hungerford, PhD
Organizational Affiliation
United States Naval Medical Center, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars D Hungerford, PhD
Phone
619-532-5715
Email
lars.d.hungerford.ctr@mail.mil
First Name & Middle Initial & Last Name & Degree
Angelica Aguirre, MPH
Phone
619-532-6132
Email
angelica.d.aguirre2.ctr@mail.mil
First Name & Middle Initial & Last Name & Degree
Lars D Hungerford, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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tDCS and Cognitive Training in Active Duty Service Members With Mild TBI: A Pilot Study

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