tDCS and Cognitive Training for Traumatic Brain Injury

Overseen By Kelvin O Lim, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Minneapolis Veterans Affairs Medical Center

Disqualifiers: Neurological disorder, Psychosis, Mania, others

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

Compensation: Varies

Number of Visits: 8

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment that combines cognitive exercises with a gentle brain stimulation technique called Transcranial Direct Current Stimulation (tDCS) to reduce impulsive behavior in individuals with traumatic brain injury (TBI). Impulsive behavior can lead to issues such as aggression or difficulty adhering to rehabilitation plans, complicating recovery. The trial includes two groups: one receiving active brain stimulation and another receiving a placebo version for comparison. Suitable candidates have a TBI and a history of impulsive behaviors, such as substance abuse or aggression, and are currently receiving care from the Minneapolis VA Health Care System. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance recovery outcomes for TBI patients.

Do I need to stop my current medications for the trial?

The trial requires that you are stable on your current medications for at least 1 week before starting. This means you can continue taking your current medications as long as they have been stable for that period.

What prior data suggests that this combination of tDCS and cognitive training is safe for individuals with traumatic brain injury?

Research has shown that transcranial direct current stimulation (tDCS) is a safe and gentle method. Studies have found that tDCS does not cause serious side effects or harm brain tissue. Even for individuals with traumatic brain injuries, a single session of tDCS proved safe.

When combined with cognitive training, research confirms its safety. This combination is believed to enhance treatment effectiveness. To date, no serious negative effects have been reported.

These findings suggest that both tDCS alone and with cognitive training are well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial involving transcranial direct current stimulation (tDCS) with cognitive training for traumatic brain injury (TBI) because it offers a non-invasive approach that targets brain activity directly. Unlike standard treatments for TBI, which often include medication and physical therapy, tDCS uses a mild electrical current to stimulate specific areas of the brain, potentially enhancing cognitive recovery. This method might offer a new way to improve brain function without the side effects often associated with drugs. Additionally, the combination with cognitive training could enhance the effectiveness of the therapy, offering hope for faster and more substantial improvements in cognitive abilities for those affected by TBI.

What evidence suggests that this trial's treatments could be effective for reducing impulsivity in TBI patients?

Research has shown that transcranial direct current stimulation (tDCS) can improve thinking skills. Studies have found that tDCS aids recovery in individuals with brain disorders, such as those caused by a stroke, by enhancing movement and cognitive abilities. For patients with traumatic brain injury (TBI), tDCS has lifted mood and reduced depression, while also enhancing thinking skills. In this trial, participants will receive either active tDCS or sham tDCS. Combining active tDCS with mental exercises could further amplify these positive effects, offering a hopeful way to improve life for those recovering from a TBI. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a traumatic brain injury (TBI) who are being treated at the Minneapolis VA Health Care System. They should be stable on medications and have a history of impulsive behavior, like substance abuse or aggression. People can't join if they're pregnant, have scalp skin issues, metal in their head, active psychosis/mania, or other major neurological disorders.

Inclusion Criteria

Age 18 or older

Receiving services from the Minneapolis VA Health Care System

Stable on any medications for at least 1 week at the baseline visit

Exclusion Criteria

You are currently experiencing severe mental health issues such as psychosis or mania.

You have a skin condition on your scalp that may be irritated during the study.

You are currently pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or sham tDCS paired with cognitive training tasks once a day for five days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits at 1, 2, and 3 months

3 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Active Transcranial Direct Current Stimulation (tDCS)
• Combined tDCS and Cognitive Training
• Sham Transcranial Direct Current Stimulation (tDCS)

Trial Overview The study tests whether combining cognitive training with an electric current treatment to the brain called tDCS can help reduce impulsivity in TBI patients. One group receives real tDCS while another gets a sham (fake) version to compare outcomes.

How Is the Trial Designed?

Group I: Active tDCS Experimental Treatment 1 Intervention

Participants will receive 5 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over left frontal cortex, cathode over right frontal cortex; 2 mAmps for 20 minutes).

Group II: Sham tDCS Placebo Group 1 Intervention

Participants will receive 5 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session.

Active Transcranial Direct Current Stimulation (tDCS) is already approved in United States, European Union for the following indications:

Approved in United States as Transcranial Direct Current Stimulation for:

• Treatment-resistant depression
• Chronic pain
• Cognitive enhancement
• Research purposes including suicide prevention

Approved in European Union as Transcranial Direct Current Stimulation for:

• Treatment-resistant depression
• Chronic pain
• Cognitive enhancement
• Research purposes including neurological and psychiatric conditions

Who Is Running the Clinical Trial?

Minneapolis Veterans Affairs Medical Center

Lead Sponsor

Trials

77

Recruited

355,000+

The Defense and Veterans Brain Injury Center

Collaborator

Trials

21

Recruited

2,900+

Center for Veterans Research and Education

Collaborator

Trials

13

Recruited

1,700+

Minnesota Office of Higher Education

Collaborator

Trials

6

Recruited

280+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6601308/

Transcranial direct current stimulation (tDCS) effects on ... Multiple studies showed improved coma recovery scales in disorders of consciousness, and improved cognition on neuropsychological assessments.

2. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2025.1552387/full

Transcranial direct current stimulation in individuals with ... Research has demonstrated positive results from the application of tDCS after stroke, such as improved motor and cognitive function, when tDCS ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04540783

The Effects of Transcranial Direct Current Stimulation ... To evaluate the early and late effects of 10 days of 20 minutes applying transcranial direct-current stimulation (tDCS) in the dorsolateral prefrontal cortex ( ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0278584623001495

Effectiveness of rTMS and tDCS treatment for chronic TBI ... This study aims at providing a systematic review and meta-analysis on the effectiveness of repetitive transcranial magnetic stimulation (TMS) and transcranial ...

5. mdpi.com mdpi.com/2077-0383/14/6/2083

Effect of Transcranial Direct Current Stimulation on Memory ... Conclusions: tDCS effectively improved emotional states, reduced depression levels, and enhanced cognitive functions in AIS and TBI patients.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666459324000088

The safety and feasibility of transcranial direct current ... Our phase I safety study indicated that a single course of tDCS was safe in patients with severe traumatic brain injury.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5007190/

Safety of transcranial Direct Current Stimulation: Evidence ... In this review, tDCS safety indicates the absence of a Serious Adverse Effect including brain tissue injury related to tDCS application. It is necessary to ...