60 Participants Needed

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

LD
A(
Overseen ByAngelica (Dilay) Aguirre, MPH
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: United States Naval Medical Center, San Diego
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is transcranial direct current stimulation (tDCS) safe for humans?

Research indicates that transcranial direct current stimulation (tDCS) is generally safe for humans, as it is a noninvasive and cost-effective approach used in various neurological conditions, including traumatic brain injury and mild cognitive impairment.12345

How does the treatment of active tDCS combined with cognitive training for mild TBI differ from other treatments?

This treatment is unique because it combines transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, with cognitive training to improve cognitive function in individuals with mild traumatic brain injury (TBI). Unlike other treatments, this approach aims to enhance brain plasticity and cognitive recovery by directly stimulating specific brain areas while simultaneously engaging patients in cognitive tasks.36789

What data supports the effectiveness of this treatment for mild TBI in active duty service members?

Research shows that transcranial direct current stimulation (tDCS) combined with cognitive training can improve cognitive functions like working memory and attention in people with traumatic brain injuries. Studies found that participants receiving this treatment had better reaction times and fewer attention-related errors compared to those who did not receive the active treatment.3891011

Who Is on the Research Team?

LD

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.
See 1 more

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.
See 6 more

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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCSExperimental Treatment1 Intervention
Group II: Sham tDCSPlacebo Group1 Intervention

Find a Clinic Near You

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

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

Citations

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. [2022]
Cognitive Telerehabilitation with Transcranial Direct Current Stimulation Improves Cognitive and Emotional Functioning Following a Traumatic Brain Injury: A Case Study. [2021]
Brain stimulation in attention deficits after traumatic brain injury: a literature review and feasibility study. [2021]
Transcranial direct current stimulation modulates working memory and prefrontal-insula connectivity after mild-moderate traumatic brain injury. [2023]
Effects of repeated anodal tDCS coupled with cognitive training for patients with severe traumatic brain injury: a pilot randomized controlled trial. [2022]
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. [2022]
Optimized high-definition tDCS in patients with skull defects and skull plates. [2023]
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. [2020]
Transcranial direct current stimulation in combination with cognitive training in individuals with mild cognitive impairment: a controlled 3-parallel-arm study. [2022]
High-definition transcranial direct current stimulation modulates theta response during a Go-NoGo task in traumatic brain injury. [2023]
Transcranial direct current stimulation (tDCS) effects on traumatic brain injury (TBI) recovery: A systematic review. [2022]
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