HD-tDCS for Traumatic Brain Injury

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: Unknown

5 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., pre-supplementary motor area) thought to aid in memory will improve verbal retrieval in civilian (non-military, non-veteran) participants with histories of traumatic brain injuries. The primary outcome measures are neuropsychological assessments of verbal retrieval, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures. Additionally, the study will examine the degree to which baseline assessments of cognition, concussion history, structural brain imaging, and EEG predict responses to treatment over time, both on assessments administered within the intervention period and at follow-up.

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 data supports the idea that HD-tDCS for Traumatic Brain Injury is an effective treatment?

The available research shows that HD-tDCS can improve cognitive performance in people with chronic traumatic brain injury. One study found that it helps with tasks that require attention and decision-making. Another study on rats showed that tDCS improved memory and behavior after a brain injury. These findings suggest that HD-tDCS could be a promising treatment for traumatic brain injury. ^{1 2 3 4 5}

What safety data exists for HD-tDCS treatment?

The safety of transcranial direct current stimulation (tDCS), including high-definition tDCS (HD-tDCS), is generally regarded as safe and well-tolerated, especially at intensities of 4 mA or less. A review of over 33,200 sessions in human trials has not reported any serious adverse effects or irreversible injuries. However, there are warnings about potential risks, and limited data exists for certain populations, such as children and older adults. Animal studies suggest that the current used in tDCS is significantly below levels that could cause brain injury. ^{6 7 8 9 10}

Is Transcranial direct current stimulation (tDCS) a promising treatment for Traumatic Brain Injury?

Yes, Transcranial direct current stimulation (tDCS) is a promising treatment for Traumatic Brain Injury. It has been shown to improve cognitive performance in individuals with chronic TBI and benefits patients with brain lesions. The treatment is non-invasive and can be optimized for patients with skull defects. ^{1 2 4 5 11}

Research Team

John Hart, MD

Principal Investigator

University of Texas at Dallas

Eligibility Criteria

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 am between 18 and 85 years old.

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.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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) 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

High-definition transcranial direct current stimulation modulates theta response during a Go-NoGo task in traumatic brain injury. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Optimized high-definition tDCS in patients with skull defects and skull plates. [2023]

3. Netherlands 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. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility of using high-definition transcranial direct current stimulation (HD-tDCS) to enhance treatment outcomes in persons with aphasia. [2023]

5. United States 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Systematic Review on the Safety and Tolerability of Transcranial Direct Current Stimulation in Children and Adolescents. [2021]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

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

11. Switzerland pubmed.ncbi.nlm.nih.gov

Reduced discomfort during high-definition transcutaneous stimulation using 6% benzocaine. [2021]