An interventional study of Active tDCS on the DLPFC + Cognitive Intervention(s) and Sham tDCS on the DLPFC + Cognitive Intervention(s) in Traumatic Brain Injury, sponsored by Johns Hopkins University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
Traumatic Brain Injury (TBI) often results in a wide array of cognitive impairments, which can significantly diminish quality of life for affected individuals. While traditional rehabilitation methods typically adopt a standardized approach, it's crucial to acknowledge the significant heterogeneity within the TBI patient population. Neglecting these variations reduces the likelihood of otherwise effective treatments being considered for widespread adoption. Emerging evidence highlights the potential of transcranial direct current stimulation (tDCS) as a promising adjunctive therapy. tDCS, a noninvasive and safe neuro-rehabilitative procedure, has shown efficacy when integrated with cognitive training across various neurological disorders, such as depression, post-stroke aphasia, and neurodegenerative conditions.
This study aims to investigate the effectiveness of tDCS paired with behavioral therapy, particularly cognitive training, in improving cognition and executive function in chronic TBI patients. Additionally, tDCs targets in the current study will be tailored to each individual patient, recognizing the patient's unique needs and circumstances
Objective: This pilot study (targeting a sample of 10 TBI patients) aims to investigate whether combining cognitive training with anodal tDCS can enhance cognitive function more effectively compared to cognitive training alone in individuals with chronic TBI. The target for tDCS application will be the left dorsolateral prefrontal cortex (DLPFC), thought to be the area associated with executive impairment in TBI patients.
Study Design: Each participant will undergo an initial neuropsychological evaluation and Functional magnetic resonance imaging (fMRI). Following the preliminary evaluation, participants will undergo either tDCS or sham stimulation for 3 weeks, with follow-up assessments immediately after and 2 months later, to measure cognitive training progress. After the 2-month follow-up, participants will undergo another 3 weeks of cognitive training with either sham or tDCS, based on the participant's condition in phase 1. Post-training, there will be additional follow-ups immediately after and 2 months later.
1,722 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 20 is below the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 314 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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Exclusion Criteria:
MRI Exclusion Criteria:
Participants will receive left DLPFC active tDCS for 3 weeks, followed by a follow-up immediately after and 2 months later. Active tDCS will be administered for 20 minutes. Cognitive training exercises will be administered concurrently with the tDCS and will take approximately 40 minutes to complete.
Combination Product: Active tDCS on the DLPFC + Cognitive Intervention(s) · Combination Product: Sham tDCS on the DLPFC + Cognitive Intervention(s)
Participants will receive left DLPFC active tDCS for 3 weeks, followed by a follow-up immediately after and 2 months later. Cognitive training exercises will be administered concurrently with the sham tDCS and will take approximately 40 minutes to complete
Combination Product: Active tDCS on the DLPFC + Cognitive Intervention(s) · Combination Product: Sham tDCS on the DLPFC + Cognitive Intervention(s)
Combination Product: Active tDCS and cognitive training intervention. Participants will receive cognitive training paired with active tDCS for 3 weeks, followed by follow-up sessions immediately after and 2 months later, during which the patient's performance on the cognitive training exercises and executive functions will be assessed. Cognitive training exercises have been drawn from a computer-aided cognitive training program (BrainHQ). For the active tDCS, stimulation will be delivered by a battery-driven constant current stimulator. The electrical current will be administered to the left DLPFC at an intensity of 2 milliamperes (mA) (estimated current density 0.04 mA/cm2; estimated total charge 0.048 Coulombs/cm2) in a ramp-like fashion for a maximum of 20 minutes.
Combination Product: Sham tDCS and cognitive training intervention Participants will receive cognitive training paired with sham tDCS for 3 weeks, followed follow-up sessions immediately after and 2 months later, during which the patient's performance on the cognitive training exercises and executive functions will be assessed. Cognitive training exercises have been drawn from a computer-aided cognitive training program (BrainHQ). For the sham tDCS, electrodes will be placed in the same area as in the active tDCS condition, but current will be administered in a ramp-like fashion but after the ramping the intensity will drop to 0 mA. Current under the Sham condition will last for a maximum of 30 seconds.
Change in Selective attention and cognitive flexibility as assessed by the Attention Network Task (ANT)
This will be measured using the Attention Network Task (ANT). An efficiency score for executive attention is derived by comparing scores on trials with congruent flankers to trials with incongruent flankers. Subjects will tend to be slower and less accurate for incongruent trials, the size of the difference indicates the extent to which an individual can supress conflicting response tendencies. A larger difference between congruent and incongruent trials score indicates a lower executive efficiency (score range: 0-96)..
Time frame: Before intervention, immediately after intervention
Change in attention and task switching as assessed by the N-Back score
The N-back task is a well-established task that assesses working memory and working memory capacity. Participants are presented with words in sequence and instructed to reply whether the current word matches the one presented 2 words ago (2-back). Scoring will be based on the total number of correct responses (hit rate) minus the number of incorrect responses (false alarm rate), where a greater score is better (score range: 0-80).
Time frame: Before intervention, immediately after intervention
Change in Self-Ordered Pointing Task (SOPT)
The SOPT is a test used to assess executive functioning. In this task, participants are shown a series of pages, each displaying the same set of abstract images arranged in a random order. On each page, the participant must point to one image, ensuring not to select the same image more than once across the entire series. A correct response involves selecting a previously un-chosen image, while an error is recorded when a participant selects an image already chosen on a previous page. Performance will be measured by total number of errors measured out of the total number of possible responses, with a higher error count indicating greater impairment.
Time frame: Before intervention, immediately after intervention
Change in attention and task switching as assessed by the Trail Making Task
This will be measured using Trail Making Task and N-Back scores. The Trail Making Test is scored by time. Participants are allowed 0 - 300 seconds to complete the task. Less time needed to complete the task is indicative of better task-switching.
Time frame: Before intervention, immediately after intervention
Change in Digit Span Forward
Digit span forward involves the recall of a series of single digits (sets of 1-8 digits) in the same order the digits were presented. Scoring is based on the number of digits or blocks shown in a trial (i.e. 1,7 is 2 digits). There are two trials for each span, if both trials are correct the score is a whole number (i.e. 2). If one trial is incorrect in a span, subtract 0.5 from that tier (i.e. 1.5). A higher number is considered better. (Score range for forward tasks: 0-9)
Time frame: Before intervention, immediately after intervention
Change in Digit Span Backward
This will be measured using Digit Span Backward for verbal working memory and spatial span Backward for spatial working memory. The digit span backward is a well-established task that assesses rote immediate verbal memory and working memory. Participants are presented with a series of digits and are instructed to repeat the digits in the reverse order. Scoring is based on the number of digits shown in a trial (i.e. 1,7 is 2 digits). There are two trials for each span, if both trials are correct the score is a whole number (i.e. 2). If one trial is incorrect in a span, subtract 0.5 from that tier (i.e. 1.5). A higher number is considered better. (Score range for backwards tasks: 0-8)
Time frame: Before intervention, immediately after intervention
Change in attention and inhibition as assessed by the Simon Task
This will be measured using Simon test scores. The Simon task assesses an individual's ability to flexibly shift the perceptual focus in response to changing demands, particularly the participant's capacity to inhibit a habitual response in favor of an unconventional one. Performance on the Simon task is typically scored based on measures such as reaction time and accuracy. Increased reaction times and higher error rates on incongruent trials are indicative of greater difficulty in inhibiting the interference caused by the word's meaning, reflecting decreased cognitive flexibility and inhibition abilities (accuracy score range: 0-120).
Time frame: Before intervention, immediately after intervention
Change in Spatial Span Forward
Spatial span forward involves the recall of a series of of positions on a board (sets of 1-9) in the same order the digits were presented. Scoring is based on the number of blocks shown in a trial (i.e. 1,7 is 2 blocks). There are two trials for each span, if both trials are correct the score is a whole number (i.e. 2). If one trial is incorrect in a span, subtract 0.5 from that tier (i.e. 1.5). A higher number is considered better. (Score range for forward tasks: 0-9)
Time frame: Before intervention, immediately after intervention
Change in Spatial Span Backward
This will be measured using Spatial Span Backward. Participants are presented with a series of block positions and are instructed to repeat the positions in the reverse order. Scoring is based on the number of blocks shown in a trial (i.e. 1,7 is 2 blocks). There are two trials for each span, if both trials are correct the score is a whole number (i.e. 2). If one trial is incorrect in a span, subtract 0.5 from that tier (i.e. 1.5). A higher number is considered better. (Score range for backwards tasks: 0-8)
Time frame: Before intervention, immediately after intervention
Change in Global Cognitive Scores as assessed by the Montreal Cognitive Assessment (MoCA)
This will be measured using the Montreal Cognitive Assessment (MoCA). Scored from 0-30 points, higher is better.
Time frame: Before intervention, immediately after intervention
Change in verbal fluency task score
Verbal fluency tasks (semantic and letter fluency) involve generating as many words as possible in one minute. Scoring will be based on number of words generated per minute. The investigators will compute the raw score of items correct and compute change in outcome between baseline and each time point. Increase in score is considered benefit.
Time frame: Before intervention, immediately after intervention
Change in semantic content of connected speech
Using the Cookie Theft image from the Boston Diagnostic Aphasia Examination (BDAE) investigators will obtain representative language samples as participants describe the images. The investigators will compute the raw score of items (semantics) correct and transform to percent correct (range: 0-100%), computing change in outcome in percent difference between before intervention and each time point after. Increase in score is considered a benefit.
Time frame: Before intervention, immediately after intervention
Change in spelling as assessed by the Johns Hopkins Dysgraphia battery
Accuracy in spelling using the Johns Hopkins Dysgraphia battery will be compared for tDCS and sham conditions. The investigators will compute the raw score of items correct using a spelling scoring system accounting for additions, substitutions, and deletions. Each word will get a score from 0-1 and the average of pseudowords and real words will be computed and transformed to percent correct (range: 0-100%), computing change in outcome in percent difference before intervention and each time point after. Increase in score is considered a benefit.
Time frame: Before intervention, immediately after intervention
Change in Oral Naming as assessed by Boston Naming Test score
Accuracy in oral picture naming (30-item Boston Naming Test) will be compared for tDCS and sham conditions. The Boston Naming Test is a widely used picture naming test that detects lexical retrieval deficits in the oral modality. The investigators will compute the raw score of items correct (range 0-30 items) and transform to percent correct (range: 0-100%), computing change in outcome in percent difference between before intervention and each time point after. Increase in score is considered a benefit.
Time frame: Before intervention, immediately after intervention
No study locations are listed for this record.
Start is estimated for Jan 2027; primary completion for Oct 2029, 33 months later.
Of 442 non-industry interventional studies with no phase under Brain Injuries, Traumatic, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 64. This study's planned 33 months is below that.
Counting every sponsor, half of 464 studies reached it within 40 months; a quarter within 22 and three quarters within 64.
Start moved once since we started tracking on Sep 25, 2026: Nov 2026 → Jan 2027, on Nov 12, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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