HD-tDCS for Traumatic Brain Injury

No longer recruiting at 1 trial location

Overseen By Ashna Adhikari, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas at Dallas

Disqualifiers: Dementia, Epilepsy, Stroke, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 23

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a gentle electric stimulation technique, transcranial Direct Current Stimulation (tDCS), can improve memory in individuals with a traumatic brain injury. Specifically, it examines whether this treatment can ease word-finding during speech. Participants will receive either the real stimulation followed by a placebo (fake) one, or vice versa. This trial suits non-military adults who experienced a mild to moderate brain injury over a year ago and struggle with word recall. As an unphased trial, participants contribute to groundbreaking research that may lead to new methods for enhancing memory after brain injury.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a history of drug abuse, you may be excluded from participating.

What prior data suggests that transcranial direct current stimulation is safe for improving verbal retrieval in individuals with traumatic brain injuries?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe. In one study with patients who had severe brain injuries, a single session of tDCS caused no major side effects. Additionally, a thorough review of tDCS safety found no serious issues, such as brain tissue damage, linked to its use. Although tDCS isn't officially approved for medical treatment, the FDA considers it low risk for individuals with brain-related conditions. This suggests that tDCS is usually well-tolerated and rarely leads to serious problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial direct current stimulation (tDCS) for traumatic brain injury because it offers a non-invasive way to potentially enhance brain function and recovery. Unlike traditional treatments that might focus on medication or physical therapy, tDCS uses low electrical currents to stimulate specific brain areas. This method could lead to quicker recovery times and improved cognitive outcomes. Additionally, the flexibility of switching between sham and active stimulation in trials helps researchers understand its true impact, offering hope for more personalized treatment strategies in the future.

What evidence suggests that transcranial direct current stimulation is effective for improving verbal retrieval in traumatic brain injury?

Research has shown that transcranial direct current stimulation (tDCS) can enhance thinking skills, particularly after brain injuries. A more advanced version, HD-tDCS, demonstrated improved cognitive clarity in individuals with long-term brain injuries. In this trial, participants will receive either active or sham stimulation to assess HD-tDCS's effects on traumatic brain injury (TBI). Although only a few studies have specifically examined tDCS for TBI, early results suggest promise for enhancing cognitive abilities. ^{1 3 6 7 8}

Who Is on the Research Team?

John Hart, MD

Principal Investigator

University of Texas at Dallas

Are You a Good Fit for This Trial?

This trial is for civilian adults aged 18-85 who have had a mild to moderate traumatic brain injury over a year ago and are experiencing word finding difficulties. They must be fluent in English, without implanted devices, major psychological or neurological disorders, current drug abuse, pregnancy, or skull defects.

Inclusion Criteria

My brain injury is considered mild to moderate.

Participants must be fluent in speaking and reading English

I've had a brain injury over a year ago and struggle with finding words.

Exclusion Criteria

Current pregnancy

I am unable to understand and agree to the study's details.

I have a history of a serious brain-related health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessments of cognition, concussion history, structural brain imaging, and EEG are conducted

1 week

1 visit (in-person)

Treatment

Participants receive either active or sham tDCS treatment for 20 minutes over 10 sessions

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with neuropsychological and EEG assessments

2 months

1 visit (in-person)

Second Round of Treatment

Participants are re-assigned to the opposite treatment condition and receive 20 minutes of tDCS over 10 sessions

2 weeks

10 visits (in-person)

Second Follow-up

Participants are monitored again for safety and effectiveness after the second round of treatment

2 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial direct current stimulation

Trial Overview The study tests if low-level electric brain stimulation (tDCS) on the pre-supplementary motor area improves verbal retrieval in people with traumatic brain injuries. It involves comparing active tDCS with sham (placebo) treatment using neuropsychological assessments and EEG measures.

How Is the Trial Designed?

Group I: Sham to Active transcranial direct current stimulation Experimental Treatment 2 Interventions

Subjects in this arm will first be randomly assigned to receive sham stimulation. After completion of sham stimulation, subjects will be assigned to active stimulation.

Group II: Active to Sham Transcranial direct current stimulation Experimental Treatment 2 Interventions

Subjects in this arm will first be randomly assigned to receive active stimulation. After completion of active stimulation, subjects will be assigned to sham stimulation.

Transcranial direct current stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as tDCS for:

• Depression
• Chronic pain
• Stroke rehabilitation
• Traumatic brain injury rehabilitation

Approved in European Union as tDCS for:

• Major depressive disorder
• Chronic pain
• Stroke rehabilitation
• Traumatic brain injury rehabilitation

Approved in Canada as tDCS for:

• Depression
• Chronic pain
• Stroke rehabilitation
• Traumatic brain injury rehabilitation

Who Is Running the Clinical Trial?

The University of Texas at Dallas

Lead Sponsor

Trials

71

Recruited

108,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

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]

High-Definition transcranial Direct Current Stimulation (HD-tDCS) at amplitudes up to 4 mA was well tolerated by 292 older adults, with no safety-related adverse events reported and mostly mild sensations experienced during sessions.

The study demonstrated effective blinding for both participants and researchers, indicating that the sham stimulation was convincing, which supports the use of higher amplitudes for potentially greater therapeutic effects in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of high-definition transcranial direct current stimulation among older adults at intensities of up to 4 mA per electrode. El Jamal, C., Harrie, A., Rahman-Filipiak, A., et al.[2023]

Anodal transcranial direct current stimulation (tDCS) applied two weeks after traumatic brain injury (TBI) significantly improved behavioral and spatial memory in a rat model, as evidenced by better performance in the Barnes maze and Rotarod tests.

The study found that tDCS did not worsen brain injury or edema, indicating it is a safe intervention; however, the positive effects on memory did not last beyond the stimulation period, suggesting the need for ongoing treatment for sustained benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of anodal transcranial direct current stimulation (tDCS) on behavioral and spatial memory during the early stage of traumatic brain injury in the rats. Yoon, KJ., Lee, YT., Chae, SW., et al.[2022]

High Definition transcranial direct current stimulation (HD-tDCS) is safe and well-tolerated in older adults, with no serious adverse events reported during a study involving 101 participants at stimulation intensities of 2 mA and 3 mA.

The study demonstrated effective blinding, as participants could not accurately distinguish between active and sham stimulation, indicating that HD-tDCS can be reliably used in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. Reckow, J., Rahman-Filipiak, A., Garcia, S., et al.[2020]

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]

Transcranial direct current stimulation (tDCS) has been found to be safe for use in humans, with no severe complications reported in studies involving both adults and children when applied at intensities of 4 mA or less for up to 60 minutes.

Animal studies indicate that the electrical current used in tDCS is significantly lower than the threshold that could cause permanent changes to brain tissue, suggesting a strong safety profile for this neurorehabilitation method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. Ko, MH.[2023]

High-Definition transcranial Direct Current Stimulation (HD-tDCS) is a safe and well-tolerated method for non-invasive brain stimulation, even when using a 2 mA current for 22 minutes.

Using a 6% benzocaine topical numbing agent significantly reduces discomfort during HD-tDCS sessions, which can improve the quality of sham-controlled studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced discomfort during high-definition transcutaneous stimulation using 6% benzocaine. Guleyupoglu, B., Febles, N., Minhas, P., et al.[2021]

Transcranial direct current stimulation (tDCS) appears to be safe and well-tolerated in youth, based on a synthesis of studies involving 156 children and a total of 864 active sessions.

The reviewed literature supports the acceptability of tDCS in pediatric populations, with only a small percentage of sessions (4.4%) conducted on neurotypical controls, indicating a focus on clinical subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review on the Safety and Tolerability of Transcranial Direct Current Stimulation in Children and Adolescents. Buchanan, DM., Bogdanowicz, T., Khanna, N., et al.[2021]

High-definition transcranial direct current stimulation (HD-tDCS) is feasible and acceptable for patients with chronic post-stroke aphasia, showing that it can be implemented effectively in a clinical setting with similar protocols to conventional sponge-based tDCS.

Preliminary results indicate that HD-tDCS may improve naming accuracy and response time in patients, with some evidence suggesting it could be more effective than conventional tDCS, although the differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of using high-definition transcranial direct current stimulation (HD-tDCS) to enhance treatment outcomes in persons with aphasia. Richardson, J., Datta, A., Dmochowski, J., et al.[2023]

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]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1388245722008690

High-definition transcranial direct current stimulation ... High Definition transcranial Direct Current Stimulation (HD-tDCS) has been shown to improve cognitive performance in individuals with chronic traumatic brain ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36108520/

High-definition transcranial direct current stimulation ... High Definition transcranial Direct Current Stimulation (HD-tDCS) has been shown to improve cognitive performance in individuals with chronic traumatic brain ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06228872

"Cognitive Rehabilitation With Direct Current Transcranial ... Transcranial Direct Current Stimulation (tDCS) has shown effectiveness in enhancing neuroplasticity in various neurological and psychiatric conditions 63.

4. 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.

5. frontiersin.org frontiersin.org/journals/neuroergonomics/articles/10.3389/fnrgo.2023.1170473/full

A map of evidence using transcranial direct current ... Only two small TBI trials have been conducted based on the most recent systematic review of tDCS effectiveness for cognition following neurological impairment.

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 ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04540783

The Effects of Transcranial Direct Current Stimulation ... We designed a proof of concept study, randomized, double-blind, placebo-controlled to evaluate 36 adult TBI patients. To evaluate the early and late effects of ...