Brain ConcussionNCT04925453
tDCS and Cognitive Training in Active Duty Service Members With Mild TBI: A Pilot Study
A study testing active tDCS and cognitive training intervention in people with Brain Concussion and Brain Trauma, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Brain Concussion, Brain Trauma, Attention Concentration Difficulty
- What is being tested?
- active tDCS and cognitive training intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2021to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- (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).
Who cannot join
- (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.
Show all 9Show fewer
- (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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center San Diego
San Diego, California, 92134
About this 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
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.
Read the 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.
- Conditions
- Brain Concussion, Brain Trauma, Attention Concentration Difficulty, Brain Injuries, Brain Injuries, Traumatic, Neurocognitive Dysfunction
- Being tested
- active tDCS and cognitive training intervention, sham tDCS and cognitive training intervention
- Keywords
- military health, brain stimulation, cognitive training, cognitive rehabilitation
- Medical subject headings
- Brain Concussion, Brain Injuries, Traumatic, Brain Injuries, Cognition Disorders, Memory Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active tDCS and cognitive training interventionCombination product
Also called intervention group, active group
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.
sham tDCS and cognitive training interventionCombination product
Also called fake tDCS group, placebo group, sham group
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.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | 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. Receives: Combination Product: active tDCS and cognitive training intervention |
| Sham tDCS | Sham comparator | 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. Receives: Combination Product: sham tDCS and cognitive training intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symbol Digit Modalities Test (SDMT)
Standardized neuropsychological assessment measure of visual attention and working memory
Measured: Change from Baseline SDMT at 1 week after the intervention.
Symbol Digit Modalities Test (SDMT)
Standardized neuropsychological assessment measure of visual attention and working memory
Measured: Change from Baseline SDMT at 6 weeks after the intervention.
Symbol Digit Modalities Test (SDMT)
Standardized neuropsychological assessment measure of visual attention and working memory
Measured: Change from 1 week post-intervention SDMT at 6 weeks after the intervention.
Neuropsychological Assessment Battery (NAB) Attention Module
Standardized neuropsychological assessment consisting of 4 subtests to assess visual and auditory attention, working memory, and scanning.
Measured: Change from Baseline NAB Attention Module at 1 week after the intervention.
Neuropsychological Assessment Battery (NAB) Attention Module
Standardized neuropsychological assessment consisting of 4 subtests to assess visual and auditory attention, working memory, and scanning.
Measured: Change from Baseline NAB Attention Module at 6 weeks after the intervention.
Neuropsychological Assessment Battery (NAB) Attention Module
Standardized neuropsychological assessment consisting of 4 subtests to assess visual and auditory attention, working memory, and scanning.
Measured: Change from 1 week post-intervention NAB Attention Module at 6 weeks after the intervention.
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.
Measured: Change from Baseline EEG at 1 week after the intervention.
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.
Measured: Change from Baseline EEG at 6 weeks after the intervention.
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.
Measured: Change from 1 week post-intervention EEG at 6 weeks after the intervention.
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.
Measured: Change from Baseline NSI at 1 week after the intervention.
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.
Measured: Change from Baseline NSI at 6 weeks after the intervention.
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.
Measured: Change from 1 week post-intervention NSI at 6 weeks after the intervention.
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.
Measured: Change from Baseline MRI at 1 week after the intervention.
Secondary outcomes (11)
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.
Measured: Change from Baseline NeuroQoL at 1 week after the intervention.
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.
Measured: Change from Baseline NeuroQoL at 6 weeks after the intervention.
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.
Measured: Change from 1 week post-intervention NeuroQoL at 6 weeks after the intervention.
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.
Measured: Change from Baseline ISI at 1 week after the intervention.
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.
Measured: Change from Baseline ISI at 6 weeks after the intervention.
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.
Measured: Change from 1 week post-intervention ISI at 6 weeks after the intervention.
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.
Measured: Change from Baseline Fusion task at 1 week after the intervention.
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.
Measured: Change from Baseline Fusion task at 6 weeks after the intervention.
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.
Measured: Change from 1 week post-intervention Fusion task at 6 weeks after the intervention.
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.
Measured: Change from pre-intervention SRQ at post-intervention.
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.
Measured: Immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start19 Jan 2021
- Primary completion30 Jun 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blind, randomized, placebo (sham) controlled pilot study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Collaborators
- The Defense and Veterans Brain Injury Center
- Responsible party
- Principal investigator, Lars Hungerford, United States Naval Medical Center, San Diego
- Investigators
- Lars D Hungerford, PhD, Principal investigator, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925453
- Sponsor's protocol ID
- NMCSD.2020.0016
- Status last verified
- Nov 2025
- First submitted
- 8 Sep 2020
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04925453
- Acronym / sponsor ID
- NMCSD.2020.0016
- Conditions
- Brain Concussion, Brain Trauma, Attention Concentration Difficulty, Brain Injuries, Brain Injuries, Traumatic, Neurocognitive Dysfunction
- Keywords
- military health, brain stimulation, cognitive training, cognitive rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Collaborators
- The Defense and Veterans Brain Injury Center
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a double-blind, randomized, placebo (sham) controlled pilot study.
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Combination Product: active tDCS and cognitive training interventionBased 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. |
| Sham tDCS | Sham comparator | Combination Product: sham tDCS and cognitive training interventionFor 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- (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).
Key exclusion criteria (9 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active tDCS and cognitive training interventionAlso: intervention group, active groupIntervention 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. | Combination product | Active tDCS |
| sham tDCS and cognitive training interventionAlso: fake tDCS group, placebo group, sham groupIntervention 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. | Combination product | Sham tDCS |
Primary outcome
Symbol Digit Modalities Test (SDMT)
Time frame: Change from Baseline SDMT at 1 week after the intervention.
Standardized neuropsychological assessment measure of visual attention and working memory
Symbol Digit Modalities Test (SDMT)
Time frame: Change from Baseline SDMT at 6 weeks after the intervention.
Standardized neuropsychological assessment measure of visual attention and working memory
Symbol Digit Modalities Test (SDMT)
Time frame: Change from 1 week post-intervention SDMT at 6 weeks after the intervention.
Standardized neuropsychological assessment measure of visual attention and working memory
Neuropsychological Assessment Battery (NAB) Attention Module
Time frame: Change from Baseline NAB Attention Module at 1 week after the intervention.
Standardized neuropsychological assessment consisting of 4 subtests to assess visual and auditory attention, working memory, and scanning.
Neuropsychological Assessment Battery (NAB) Attention Module
Time frame: Change from Baseline NAB Attention Module at 6 weeks after the intervention.
Standardized neuropsychological assessment consisting of 4 subtests to assess visual and auditory attention, working memory, and scanning.
Neuropsychological Assessment Battery (NAB) Attention Module
Time frame: Change from 1 week post-intervention NAB Attention Module at 6 weeks after the intervention.
Standardized neuropsychological assessment consisting of 4 subtests to assess visual and auditory attention, working memory, and scanning.
Electroencephalogram (EEG)
Time frame: Change from Baseline EEG at 1 week after the intervention.
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)
Time frame: Change from Baseline EEG at 6 weeks after the intervention.
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)
Time frame: Change from 1 week post-intervention EEG at 6 weeks after the intervention.
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)
Time frame: Change from Baseline NSI at 1 week after the intervention.
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)
Time frame: Change from Baseline NSI at 6 weeks after the intervention.
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)
Time frame: Change from 1 week post-intervention NSI at 6 weeks after the intervention.
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)
Time frame: Change from Baseline MRI at 1 week after the intervention.
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.
11 secondary outcomes
NIH Toolbox Quality of Life Assessment (NeuroQoL)
Time frame: Change from Baseline NeuroQoL at 1 week after the intervention.
NIH Toolbox Quality of Life Assessment (NeuroQoL)
Time frame: Change from Baseline NeuroQoL at 6 weeks after the intervention.
NIH Toolbox Quality of Life Assessment (NeuroQoL)
Time frame: Change from 1 week post-intervention NeuroQoL at 6 weeks after the intervention.
Insomnia Severity Index (ISI)
Time frame: Change from Baseline ISI at 1 week after the intervention.
Insomnia Severity Index (ISI)
Time frame: Change from Baseline ISI at 6 weeks after the intervention.
Insomnia Severity Index (ISI)
Time frame: Change from 1 week post-intervention ISI at 6 weeks after the intervention.
Fusion Task
Time frame: Change from Baseline Fusion task at 1 week after the intervention.
Fusion Task
Time frame: Change from Baseline Fusion task at 6 weeks after the intervention.
Fusion Task
Time frame: Change from 1 week post-intervention Fusion task at 6 weeks after the intervention.
tDCS Symptom Rating Questionnaire (SRQ)
Time frame: Change from pre-intervention SRQ at post-intervention.
BrainHQ Task Load Index (TLX)
Time frame: Immediately after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars D Hungerford, PhD principal investigator
United States Naval Medical Center, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active tDCS and cognitive training intervention in people with Brain Concussion and Brain Trauma, run by United States Naval Medical Center, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symbol Digit Modalities Test (SDMT) (time frame: Change from Baseline SDMT at 1 week after the intervention.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.