tDCS + Cognitive Training for Brain Injury and PTSD

Overseen By Kelly L Sloane, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: VA Office of Research and Development

Disqualifiers: Seizure disorder, Stroke, Bipolar, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 13

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if transcranial direct current stimulation (tDCS) can improve thinking and memory in Veterans with both traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD). The trial will compare real tDCS treatment to a sham version to assess its effectiveness. This study may suit Veterans who experienced a mild TBI over five years ago, have had PTSD symptoms in the last month, and notice memory or focus issues. Participants must have internet access for an hour a day. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

What prior data suggests that transcranial direct current stimulation (tDCS) is safe for improving cognitive function in Veterans with TBI and PTSD?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe and well-tolerated. Studies often find that tDCS does not cause serious issues like brain injury. Some individuals might experience minor side effects, such as tingling, itching, or mild redness on the skin where the device is applied. Others have reported feeling tired or having a mild headache. These effects are usually temporary and not harmful.

In past studies, researchers successfully tested tDCS as a non-invasive method to assist with various brain conditions. It is often combined with other therapies to aid recovery and rehabilitation. The treatment is already recognized for its safety and effectiveness in similar contexts, suggesting that trial participants can expect a comparable level of safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for TBI and PTSD?

Researchers are excited about transcranial direct current stimulation (tDCS) for brain injury and PTSD because it offers a non-invasive way to modulate brain activity. Unlike traditional treatments like medication or talk therapy, tDCS uses mild electrical currents to stimulate specific brain areas, which could enhance the brain's ability to heal and improve cognitive function. This method is particularly appealing because it has the potential to be used alongside other therapies, possibly making them more effective. Moreover, tDCS is generally well-tolerated, with fewer side effects compared to medications, which is a significant advantage for patients seeking alternative treatment options.

What evidence suggests that transcranial direct current stimulation (tDCS) might be an effective treatment for cognitive impairment due to TBI and PTSD?

Studies have shown that transcranial direct current stimulation (tDCS) can enhance cognitive abilities in individuals with traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD). Research indicates that tDCS effectively boosts memory, attention, and problem-solving skills in TBI patients. Additionally, individuals with PTSD have experienced significant symptom relief following tDCS treatment. This trial will compare active tDCS with sham tDCS to assess its effectiveness. The technique gently stimulates specific brain areas to aid recovery and rehabilitation. Overall, tDCS shows promise in assisting those with cognitive difficulties related to TBI and PTSD. ^{2 3 4 6 7}

Who Is on the Research Team?

Kelly L Sloane, PhD

Principal Investigator

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Are You a Good Fit for This Trial?

Inclusion Criteria

History of PTSD with symptoms within the last month as confirmed PTSD Checklist (past month) score greater than or equal to 33

History of chronic mTBI as measured by Ohio State University Traumatic Brain Injury Identification Method

My mild traumatic brain injury happened more than 5 years ago.

Exclusion Criteria

Skin lesions at the stimulation site that may increase conductance

Metallic objects in the face or head (e.g. braces, fillings, implants)

Pregnancy/lactation or planning to become pregnant during study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 10 weekdays of tDCS stimulation paired with cognitive training using the BrainHQ mobile application, conducted remotely.

2 weeks

10 visits (remote)

Follow-up

Participants are monitored for cognitive function improvements and safety, with cognitive testing conducted at 3 timepoints: prior to initiation, after the last stimulation, and 2 months post-treatment.

2 months

3 visits (remote)

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Direct Current Stimulation (tDCS)

How Is the Trial Designed?

Group I: tDCS Active Control 2 Interventions

Active transcranial direct current stimulation (tDCS)

Group II: Sham tDCS Placebo Group 2 Interventions

Sham transcranial direct current stimulation (tDCS)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

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

Transcranial direct current stimulation (tDCS) effects on ... - PMC

Less than a quarter of moderate and severe TBI patients improved in their cognition within 5 years. Non-invasive brain stimulation, including transcranial ...

2.

jamanetwork.com

jamanetwork.com/journals/jamapsychiatry/fullarticle/2815835

Virtual Reality and Transcranial Direct Current Stimulation ...

Participants in the active tDCS group reported a superior reduction in self-reported PTSD symptom severity at 1 month (t = −2.27, P = .02; Cohen ...

3.

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 was combined with ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02849223

Transcranial Direct Current Stimulation (TDCS) as an ...

This study will provide preliminary evidence of the efficacy of providing tDCS as an intervention to enhance cognitive and functional outcomes for individuals ...

5.

mdpi.com

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

Effect of Transcranial Direct Current Stimulation on Memory ...

Results: Significant improvements in emotional states were observed post-tDCS. Hedonic tone increased (AIS: 2.5 to 5 stens; TBI: 1.5 to 4 stens) ...

6.

pmc.ncbi.nlm.nih.gov

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

Safety of transcranial Direct Current Stimulation - PMC - NIH

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 ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1935861X16301401

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 ...