Active tDCS + Cognitive Training for Mild TBI in Active Duty Service Members

Overseen By Angelica (Dilay) Aguirre, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: United States Naval Medical Center, San Diego

Must not be taking: Stimulants

Disqualifiers: Seizures, Epilepsy, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat mild traumatic brain injury (mTBI) using transcranial direct current stimulation (tDCS) combined with cognitive training. The researchers aim to determine if this combination can improve attention and memory issues in active duty service members with a history of mild TBI. Participants will receive either real or sham (inactive) tDCS to compare effects. The trial seeks active duty members who experienced mild TBI more than six months ago and face moderate attention or memory problems. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be stable on any medications for at least 2 weeks before starting the trial.

What prior data suggests that this brain stimulation technique is safe for cognitive rehabilitation?

Studies have shown that transcranial direct current stimulation (tDCS) safely stimulates the brain. The FDA considers it low risk for individuals with neurological issues. Research on people with severe traumatic brain injury found that a single use of tDCS was safe. Although not yet approved for regular medical use, tDCS has been safely used in trials.

Cognitive training, another part of this trial, improves thinking and memory skills in people with mild traumatic brain injury (TBI). Reviews have found cognitive training to be safe and helpful, especially for those with mild to moderate TBI.

Overall, both tDCS and cognitive training are well-tolerated, with minimal risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they combine cognitive training with transcranial Direct Current Stimulation (tDCS) to target Mild Traumatic Brain Injury (TBI). Unlike traditional therapies that often focus on medication or physical therapy, tDCS uses a non-invasive electrical current to stimulate specific brain areas, potentially enhancing cognitive function and recovery. This method could offer a more direct way to improve working memory and cognitive performance, providing a novel approach to treating Mild TBI in active duty service members.

What evidence suggests that this trial's treatments could be effective for mild TBI?

Research shows that transcranial direct current stimulation (tDCS) may improve thinking and movement skills. Studies have found that tDCS can be particularly beneficial after a stroke by enhancing neuroplasticity, the brain's ability to change and heal itself. In individuals with consciousness disorders, tDCS has improved scores on cognitive tests. This trial will compare active tDCS with sham tDCS to evaluate its effectiveness in aiding recovery from mild traumatic brain injuries (mTBI). Although more research is needed, these findings suggest that tDCS might be useful for mTBI recovery. ^{6 7 8 9 10}

Who Is on the Research Team?

Lars D Hungerford, PhD

Principal Investigator

United States Naval Medical Center, San Diego

Are You a Good Fit for This Trial?

Active Duty Service Members aged 18-55 with a history of mild TBI at least 6 months prior and moderate neurocognitive symptoms. Participants must be stable on medications for two weeks before starting the trial. Exclusions include a history of seizures, recent neuromodulation studies, intellectual disability, significant neurological disorders other than mild TBI, current stimulant dependence or active psychosis/manic episodes.

Inclusion Criteria

You had a mild traumatic brain injury at least 6 months ago and still have problems with attention, memory, or thinking according to a specific test and your own report.

Are stable on any medications for at least 2 weeks at the baseline visit (Visit #1)

You had a mild brain injury more than 6 months ago and still have trouble with memory or paying attention.

Exclusion Criteria

You have had seizures or epilepsy in the past.

You had electroconvulsive therapy (ECT) or other brain stimulation treatments in the past year, or took part in similar research studies.

You have been diagnosed with a condition that affects how you learn and understand things, or how you develop.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial direct current stimulation (tDCS) combined with cognitive training over five consecutive days

1 week

5 visits (in-person)

Post-intervention Assessment

Participants undergo post-intervention assessment of symptoms, neurocognitive performance, and optional MRI scan

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of symptoms and neurocognitive performance

6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Training Intervention
• tDCS

Trial Overview The study tests whether brain stimulation (tDCS) combined with cognitive training can improve attention and memory in those with mild TBI. It compares the effects of actual tDCS versus sham (fake) treatment alongside cognitive exercises to assess improvements in brain function and self-reported outcomes.

How Is the Trial Designed?

Group I: Active tDCS Experimental Treatment 1 Intervention

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.

Group II: Sham tDCS Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

United States Naval Medical Center, San Diego

Lead Sponsor

Trials

110

Recruited

24,200+

The Defense and Veterans Brain Injury Center

Collaborator

Trials

21

Recruited

2,900+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) is a safe and non-invasive treatment that shows promise in improving cognitive recovery in patients with traumatic brain injury (TBI), as evidenced by multiple studies reporting enhanced coma recovery and cognitive performance.

While tDCS can be effective on its own, combining it with other therapies like cognitive rehabilitation and physical therapy may lead to even better outcomes, and neurophysiological measures like EEG and TMS can serve as useful biomarkers for tracking progress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) effects on traumatic brain injury (TBI) recovery: A systematic review. Zaninotto, AL., El-Hagrassy, MM., Green, JR., et al.[2022]

Transcranial direct current stimulation (tDCS) was found to be safe and well-tolerated in a study involving 20 patients with mild or major neurocognitive disorders, with an attrition rate of 0% and no serious adverse events reported.

However, the study did not find any statistically significant improvements in cognitive functioning when comparing the active tDCS group to the sham group, indicating that tDCS may not enhance cognitive performance in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of Transcranial Direct Current Stimulation for Cognitive Rehabilitation in Patients With Mild or Major Neurocognitive Disorders: A Randomized Sham-Controlled Pilot Study. Inagawa, T., Yokoi, Y., Narita, Z., et al.[2022]

A case study of a 29-year-old man with cognitive and emotional issues after a traumatic brain injury showed significant improvements in attention, working memory, and mood after 20 sessions of remotely supervised transcranial direct current stimulation (RS-tDCS) combined with cognitive training.

This study is the first to demonstrate the effectiveness of at-home telerehabilitation using RS-tDCS, suggesting it could be a promising, noninvasive treatment option for cognitive deficits in TBI survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Telerehabilitation with Transcranial Direct Current Stimulation Improves Cognitive and Emotional Functioning Following a Traumatic Brain Injury: A Case Study. Eilam-Stock, T., George, A., Charvet, LE.[2021]

In a study of 34 individuals with mild-moderate traumatic brain injury (mmTBI), active transcranial direct current stimulation (tDCS) combined with executive function training led to greater improvements in working memory reaction times compared to a control group.

The improvements in reaction time were linked to changes in brain connectivity between the right dorsolateral prefrontal cortex and the left anterior insula, suggesting a potential mechanism for recovery from persistent posttraumatic symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation modulates working memory and prefrontal-insula connectivity after mild-moderate traumatic brain injury. Quinn, DK., Story-Remer, J., Brandt, E., et al.[2023]

In a study involving 62 patients with mild cognitive impairment, combining transcranial direct current stimulation (tDCS) with cognitive training resulted in significantly greater improvements in global cognitive functioning and verbal fluency compared to either treatment alone.

While all groups showed improvements in cognitive abilities after 20 sessions, the combined tDCS and cognitive training intervention was particularly effective, suggesting that tDCS can enhance the benefits of cognitive training in patients with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in combination with cognitive training in individuals with mild cognitive impairment: a controlled 3-parallel-arm study. Pallanti, S., Grassi, E., Knotkova, H., et al.[2022]

In a study involving veterans with chronic traumatic brain injury (TBI), active high-definition transcranial direct current stimulation (HD-tDCS) significantly improved cognitive performance, as evidenced by increased theta activity in the brain during a Go-NoGo task, compared to a sham treatment.

The results suggest that HD-tDCS induces specific changes in brain oscillatory activity, which could help identify individuals who are more likely to benefit from this type of intervention in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-definition transcranial direct current stimulation modulates theta response during a Go-NoGo task in traumatic brain injury. Chiang, HS., Motes, M., Kraut, M., et al.[2023]

In a study involving 32 patients with severe traumatic brain injury (TBI), those who received 10 sessions of transcranial direct current stimulation (tDCS) combined with cognitive training showed significant improvements in divided attention performance, including faster reaction times and fewer omissions.

Functional MRI results indicated that the tDCS treatment led to a normalization of brain activity, with reduced hyperactivation in several areas associated with cognitive function, suggesting that this approach may effectively aid recovery in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concomitant Use of Transcranial Direct Current Stimulation and Computer-Assisted Training for the Rehabilitation of Attention in Traumatic Brain Injured Patients: Behavioral and Neuroimaging Results. Sacco, K., Galetto, V., Dimitri, D., et al.[2022]

The study aimed to evaluate the feasibility of using transcranial direct current stimulation (tDCS) to improve attention deficits in patients with traumatic brain injury (TBI), but only 6 out of 164 patients were enrolled, and none completed the treatment protocol as intended.

Despite the low completion rate, the study found no major side effects from the tDCS treatment, suggesting that this non-invasive neurostimulation approach could be safe for enhancing attention in TBI patients, although practical implementation challenges were noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain stimulation in attention deficits after traumatic brain injury: a literature review and feasibility study. Boissonnault, È., Higgins, J., LaGarde, G., et al.[2021]

In a study involving 23 patients with severe traumatic brain injury, cumulative anodal transcranial direct current stimulation (A-tDCS) was applied alongside cognitive rehabilitation over 15 days, but did not show significant improvements in memory and attention compared to a sham treatment group.

Although the experimental group showed larger effect sizes in cognitive outcomes immediately after treatment, these differences were not statistically significant, indicating that A-tDCS may not be an effective enhancement for cognitive rehabilitation in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of repeated anodal tDCS coupled with cognitive training for patients with severe traumatic brain injury: a pilot randomized controlled trial. Leśniak, M., Polanowska, K., Seniów, J., et al.[2022]

Optimized high-definition montages for transcranial direct current stimulation (tDCS) can increase stimulation intensity by an average of 0.3 V/m compared to unoptimized montages, which is crucial for targeting areas beneath skull defects.

Large skull defects with titanium or acrylic plates can reduce stimulation intensity by about 80%, while smaller defects filled with cerebrospinal fluid or scar tissue can increase stimulation intensity by about 200%, highlighting the importance of individual anatomical considerations in tDCS treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimized high-definition tDCS in patients with skull defects and skull plates. Guillen, A., Truong, DQ., Datta, A., et al.[2023]

This study will investigate the safety and efficacy of combining transcranial direct current stimulation (tDCS) with conventional rehabilitation in 80 patients with disorders of consciousness (DOC) after traumatic brain injury (TBI) over a 4-week period.

The trial aims to provide advanced evidence for tDCS as a non-invasive treatment option to promote early awakening in DOC patients, addressing a significant gap in large-sample clinical trials for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcranial direct current stimulation on patients with disorders of consciousness after traumatic brain injury: study protocol for a randomized, double-blind controlled trial. Li, S., Dong, X., Sun, W., et al.[2020]

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