Traumatic Brain InjuryNCT06989970
Treating Traumatic Brain Injury With Transcranial Direct Current Stimulation
A study testing Active tDCS on the DLPFC + Cognitive Intervention(s) in people with Traumatic Brain Injury, run by Johns Hopkins University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Active tDCS on the DLPFC + Cognitive Intervention(s)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 15 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of traumatic brain injury (TBI) at least 2 years prior to participation
- Right-handed
- English - speaking
Who cannot join
- Uncorrected visual impairment
- Uncorrected hearing impairment
- Stroke or other premorbid neurological disorders affecting the brain
- Premorbid learning disorders
- MRI Exclusion Criteria:
- severe claustrophobia
- Cardiac pacemakers, ferromagnetic implants, cochlear implants
- pregnant woman
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mary Kosmidis, PhD. contact
About this study
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
Read the detailed description
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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Active tDCS on the DLPFC + Cognitive Intervention(s), Sham tDCS on the DLPFC + Cognitive Intervention(s)
- Keywords
- TBI, Traumatic Brain Injury, Chronic Traumatic Brain Injury, transcranial direct current stimulation, tDCS, Computerized Cognitive Therapy
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCS on the DLPFC + Cognitive Intervention(s)Combination product
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.
Sham tDCS on the DLPFC + Cognitive Intervention(s)Combination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS on the DLPFC + Cognitive Intervention(s) then Sham tDCS | Active comparator | 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. Receives: Combination Product: Active tDCS on the DLPFC + Cognitive Intervention(s); Combination Product: Sham tDCS on the DLPFC + Cognitive Intervention(s) |
| Sham tDCS on the DLPFC + Cognitive Intervention(s) then Active tDCS | Sham comparator | 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 Receives: Combination Product: Active tDCS on the DLPFC + Cognitive Intervention(s); Combination Product: Sham tDCS on the DLPFC + Cognitive Intervention(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)..
Measured: 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).
Measured: 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.
Measured: Before intervention, immediately after intervention
Secondary outcomes (6)
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.
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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)
Measured: Before intervention, immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start15 Nov 2026 (estimated)
- Primary completion15 Oct 2029 (estimated)
- Study completion15 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- This is a repeated measures crossover trial, where all participants will receive dorsolateral prefrontal cortex (DLCPFC) stimulation followed by sham stimulation or vice versa. Each condition will be separated by 2 months.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Ybrain Inc.
- Responsible party
- Sponsor
- Investigators
- Kyrana Tsapkini, PhD., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989970
- Sponsor's protocol ID
- IRB00353047
- Status last verified
- Sep 2026
- First submitted
- 30 Apr 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Traumatic Brain Injury With Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT06989970
- Acronym / sponsor ID
- IRB00353047
- Conditions
- Traumatic Brain Injury
- Keywords
- TBI, Traumatic Brain Injury, Chronic Traumatic Brain Injury, transcranial direct current stimulation, tDCS, Computerized Cognitive Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Ybrain Inc.
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Oct 2029 (estimated)
- Study completion
- 15 Oct 2029 (estimated)
- First posted
- 25 May 2025 (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.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a repeated measures crossover trial, where all participants will receive dorsolateral prefrontal cortex (DLCPFC) stimulation followed by sham stimulation or vice versa. Each condition will be separated by 2 months.
| Arm | Type | Receives |
|---|---|---|
| Active tDCS on the DLPFC + Cognitive Intervention(s) then Sham tDCS | Active comparator | 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. 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. |
| Sham tDCS on the DLPFC + Cognitive Intervention(s) then Active tDCS | Sham comparator | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of traumatic brain injury (TBI) at least 2 years prior to participation
- Right-handed
- English - speaking
Key exclusion criteria (8 listed)
- Uncorrected visual impairment
- Uncorrected hearing impairment
- Stroke or other premorbid neurological disorders affecting the brain
- Premorbid learning disorders
- severe claustrophobia
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 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 | Active tDCS on the DLPFC + Cognitive Intervention(s) then Sham tDCS, Sham tDCS on the DLPFC + Cognitive Intervention(s) then Active tDCS |
| Sham tDCS on the DLPFC + Cognitive Intervention(s)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. | Combination product | Active tDCS on the DLPFC + Cognitive Intervention(s) then Sham tDCS, Sham tDCS on the DLPFC + Cognitive Intervention(s) then Active tDCS |
Primary outcome
Change in Selective attention and cognitive flexibility as assessed by the Attention Network Task (ANT)
Time frame: Before intervention, immediately after intervention
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)..
Change in attention and task switching as assessed by the N-Back score
Time frame: Before intervention, immediately after intervention
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).
Change in Self-Ordered Pointing Task (SOPT)
Time frame: Before intervention, immediately after intervention
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.
6 secondary outcomes
Change in attention and task switching as assessed by the Trail Making Task
Time frame: Before intervention, immediately after intervention
Change in Digit Span Forward
Time frame: Before intervention, immediately after intervention
Change in Digit Span Backward
Time frame: Before intervention, immediately after intervention
Change in attention and inhibition as assessed by the Simon Task
Time frame: Before intervention, immediately after intervention
Change in Spatial Span Forward
Time frame: Before intervention, immediately after intervention
Change in Spatial Span Backward
Time frame: Before intervention, immediately after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
Related trials for Traumatic Brain Injury
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
Enrolling by invitationObservational study
Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials
Traumatic Brain Injury
RecruitingObservational study
Cortical Spreading Depolarization After Severe Traumatic Brain Injury
Traumatic Brain Injury
RecruitingObservational study
Predict Severe Traumatic Brain Injury
Traumatic Brain Injury
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.
Mary Kosmidis, PhD. contact
Kyrana Tsapkini, PhD. principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS on the DLPFC + Cognitive Intervention(s) in people with Traumatic Brain Injury, run by Johns Hopkins University.
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 8 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: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyrana Tsapkini, PhD. (4107362940, tsapkini@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Selective attention and cognitive flexibility as assessed by the Attention Network Task (ANT) (time frame: Before intervention, immediately after intervention). The study lists 3 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 24 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.