Brain Stimulation + Cognitive Training for Mild Traumatic Brain Injury

(COGNETRIC Trial)

Recruiting at 1 trial location

Overseen By Casey Gilmore, Ph.D

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: United States Naval Medical Center, San Diego

Disqualifiers: Brain tumor, Epilepsy, Schizophrenia, Bipolar, others

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

Compensation: Varies

Number of Visits: 14

Duration: 2 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new home-based method to improve attention in individuals with a history of mild traumatic brain injury (mTBI), focusing specifically on active-duty service members and veterans. The study employs a brain stimulation technique called RS-tDCS+ (Remotely Supervised Transcranial Direct Current Stimulation combined with Cognitive Training) to enhance learning and reorganize brain connections. Participants will receive either the real treatment or a sham (placebo) version to determine any differences in attention improvement. The trial seeks individuals who experienced mTBI at least three months ago and face attention or concentration difficulties in daily life. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that may enhance cognitive recovery methods.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have been newly prescribed a medication within the last 3 weeks, you may not be eligible to participate.

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

Research has shown that transcranial direct current stimulation (tDCS), including the remotely supervised version (RS-tDCS), is generally safe. Participants in studies have tolerated RS-tDCS well, with few negative effects reported. Specifically, a review of several trials found that side effects were rare and minor, with most people experiencing only mild sensations like tingling on the scalp.

One study used RS-tDCS at home and found it both safe and effective, particularly for improving symptoms in various conditions. This suggests that the treatment is suitable for use outside a medical setting, offering convenience without compromising safety.

Overall, while no treatment is completely risk-free, RS-tDCS has demonstrated a good safety record in various studies, making it a promising option for cognitive rehabilitation in mild traumatic brain injury. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this treatment because it combines cognitive training with transcranial direct current stimulation (tDCS), a unique approach for addressing mild traumatic brain injury (mTBI). Unlike traditional options, which often rely on medications or cognitive therapies alone, this method uses a non-invasive technique to stimulate specific brain areas, potentially enhancing recovery. The remotely supervised tDCS+ allows patients to receive treatment at home, making it more accessible and convenient. This novel combination could lead to faster and more effective improvements in cognitive function, a significant advantage over existing therapies.

What evidence suggests that RS-tDCS+ is effective for improving complex attention in mTBI?

Research shows that Remotely Supervised Transcranial Direct Current Stimulation with Cognitive Training (RS-tDCS+) may improve attention in people with mild traumatic brain injury (mTBI). In this trial, participants will join either an active tDCS group or a sham tDCS group. Studies have found that tDCS can boost learning and help the brain form new connections, potentially enhancing thinking skills. While evidence is still growing, some research suggests it could also benefit similar conditions, such as multiple sclerosis. Early results are promising, but more research is needed to confirm its effectiveness specifically for mTBI. ^{1 4 6 7 8}

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?

This trial is for Active Duty Service Members and Veterans who have experienced mild Traumatic Brain Injury (mTBI) and are struggling with complex attention issues. Participants should be interested in a home-based cognitive rehabilitation program using brain stimulation and cognitive training.

Inclusion Criteria

Active-Duty Service Members

My gender does not affect my eligibility.

All racial and ethnic groups

Exclusion Criteria

Psychosis or mania within 30 days of enrollment, as determined by the PI, based on a psychiatric history and examination and/or a review of available medical records

I haven't had ECT or neuromodulation treatments in the last year.

Diagnosis of intellectual disability or pervasive developmental disorder (i.e., premorbid IQ less than or equal to 70)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 sessions of cognitive training combined with transcranial direct current stimulation (RS-tDCS) over 2 weeks, conducted remotely at home.

2 weeks

10 sessions (remote)

Post-Treatment Assessment

Participants undergo post-intervention assessments including EEG and MRI to evaluate changes in brain connectivity and function.

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1 and 6 weeks post-treatment.

6 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Remotely Supervised tDCS+

Trial Overview

The study tests 'Remotely Supervised Transcranial Direct Current Stimulation combined with Cognitive Training' (RS-tDCS+), comparing active brain stimulation to sham (placebo). It aims to improve attention by enhancing learning and the brain's adaptability, measured through various tests over time.

How Is the Trial Designed?

Group I: Active tDCS Experimental Treatment 1 Intervention

Participants will receive 10 sessions of cognitive training concurrent with transcranial direct current stimulation. Stimulation will be applied for 20 minutes at the beginning of each session. Current will be ramped from 0 mA to 2 mA over 30 seconds, and then ramped down from 2 mA to 0 mA at the end of 20 minutes. Current will be applied via two electrodes consisting of a pre-inserted carbon rubber snap electrode that is pre-saturated with saline and connects directly to designated electrode sites located on the tDCS headband. The anodal stimulating electrode will be at location F3 (based on the 10-20 EEG location system) and the cathodal electrode at location F4.

Group II: Sham tDCS Placebo Group 1 Intervention

Electrodes will be placed at the same positions as for active stimulation (F3 and F4), but current will be ramped down immediately after the initial 30s ramp up period and then at 20 minutes ramped up and down as done at the beginning. Thus, participants feel the initial tingling sensation associated with tDCS, but will receive no active current for the rest of the stimulation period

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+

Minneapolis Veterans Affairs Medical Center

Collaborator

Trials

77

Recruited

355,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Center for Veterans Research and Education

Collaborator

Trials

13

Recruited

1,700+

General Dynamics Information Technology

Collaborator

Trials

1

Recruited

160+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

In a study involving 26 patients with traumatic brain injury (TBI), 10 sessions of anodal transcranial direct current stimulation (tDCS) significantly reduced theta, delta, and increased alpha EEG oscillations, indicating a positive modulation of brain activity.

Improvements in neuropsychological test performance were strongly correlated with the reduction of delta waves in the active tDCS group, suggesting that tDCS may enhance cognitive recovery in TBI patients during neurorehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cumulative effects of transcranial direct current stimulation on EEG oscillations and attention/working memory during subacute neurorehabilitation of traumatic brain injury. Ulam, F., Shelton, C., Richards, L., et al.[2022]

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]

The remotely supervised tDCS (RS-tDCS) protocol allows patients to self-administer treatment at home, significantly improving accessibility and adherence by eliminating the need for daily clinic visits, which can be challenging due to personal obligations.

In a study involving 46 patients, the RS-tDCS protocol demonstrated safety and feasibility, with a total of 748 completed sessions, suggesting it could be a scalable model for future clinical trials involving tDCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability. Shaw, MT., Kasschau, M., Dobbs, B., et al.[2018]

In a study of 26 chronic stroke patients with cognitive impairment, remotely supervised transcranial direct current stimulation (RS-tDCS) significantly improved cognitive function, particularly in those with moderate cognitive decline and lower baseline scores.

RS-tDCS was found to be safe and feasible for home-based rehabilitation, with a high adherence rate of 98.4% and no serious adverse effects reported, suggesting it could be a valuable tool for enhancing cognitive training after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Transcranial Direct Current Stimulation to Enhance Cognition in Stroke: Randomized Controlled Trial. Ko, MH., Yoon, JY., Jo, YJ., et al.[2022]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

A single session of anodal transcranial direct current stimulation (tDCS) to the left dorsolateral prefrontal cortex showed a tendency to improve reaction times in patients with traumatic brain injury, suggesting potential benefits for attention improvement.

While the immediate effects were promising, the improvements were not statistically significant after 3 or 24 hours, indicating that further research is needed to confirm the efficacy of tDCS in enhancing attention in this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation of the left prefrontal cortex improves attention in patients with traumatic brain injury: a pilot study. Kang, EK., Kim, DY., Paik, NJ.[2022]

Transcranial direct current stimulation (tDCS) showed promising early efficacy in improving working memory performance in youth with cognitive persistent post-concussion symptoms, particularly on a dual task working memory test.

The study found that participants tolerated tDCS well, with the active tDCS group reporting fewer strong symptoms compared to the sham group, suggesting it could be a feasible adjunct to behavioral therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of transcranial direct current stimulation on cognitive performance in youth with persistent cognitive symptoms following concussion: a controlled pilot study. Quinn de Launay, K., Cheung, ST., Riggs, L., et al.[2022]

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 feasibility study involving 45 participants with multiple sclerosis, those receiving remotely-supervised transcranial direct current stimulation (RS-tDCS) alongside cognitive training showed significant improvements in complex attention and response variability compared to those who only received cognitive training.

The study suggests that RS-tDCS may enhance cognitive outcomes in MS patients, particularly in areas of complex attention, indicating its potential as a beneficial telerehabilitation tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remotely Supervised Transcranial Direct Current Stimulation Increases the Benefit of At-Home Cognitive Training in Multiple Sclerosis. Charvet, L., Shaw, M., Dobbs, B., 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]

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