Transcranial Direct Current Stimulation for Traumatic Brain Injury

Overseen by John Hart, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The University of Texas at Dallas

Disqualifiers: Dementia, Epilepsy, Stroke, others

No Placebo Group

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment High Definition Transcranial Direct Current Stimulation for Traumatic Brain Injury?

Research shows that High Definition Transcranial Direct Current Stimulation (HD-tDCS) can improve cognitive performance in people with chronic traumatic brain injury. Additionally, a study found that stimulating a specific brain area improved attention in TBI patients. ^{1 2 3 4 5}

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

Transcranial direct current stimulation (tDCS) is generally considered safe for humans, with no reports of serious adverse effects or irreversible injury in over 33,200 sessions across various populations, including potentially vulnerable groups like children and the elderly. ^{1 6 7 8 9}

How is High Definition Transcranial Direct Current Stimulation (HD-tDCS) different from other treatments for traumatic brain injury?

High Definition Transcranial Direct Current Stimulation (HD-tDCS) is unique because it uses targeted electrical currents to improve cognitive function in traumatic brain injury patients, even those with skull defects. Unlike traditional treatments, it is non-invasive and focuses on enhancing brain activity rather than using medication. ^{1 2 3 10 11}

Research Team

John Hart, MD

Principal Investigator

The University of Texas at Dallas

Eligibility Criteria

This trial is for civilian adults with a history of traumatic brain injury who struggle to find words (anomia). They should not be military or veterans. Participants must be able to undergo neuropsychological assessments and EEG measures, and have no other conditions that could interfere with the study.

Inclusion Criteria

Participants have had a traumatic brain injury more than a year ago prior to study participation

I have trouble finding words due to a brain injury, confirmed by tests.

I am between 18 and 85 years old.

Exclusion Criteria

I have a defect in my skull.

Presence of an implanted/electronic device such as a pacemaker, metallic cranial or intracranial implant (e.g., ventriculoperitoneal shunt), or a neurostimulator (e.g., vagus nerve stimulator, spinal stimulator, deep brain stimulator, etc.)

Currently pregnant

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or sham transcranial direct current stimulation (tDCS) for 20 minutes over 10 sessions

2-4 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 2-months post-treatment

8 weeks

1 visit (in-person)

Second Treatment

Participants are re-assigned to the opposite treatment condition (active or sham) for another 20 minutes over 10 sessions

2-4 weeks

10 visits (in-person)

Second Follow-up

Participants are monitored again for safety and effectiveness after the second treatment, with assessments at 2-months post-treatment

8 weeks

1 visit (in-person)

Treatment Details

Interventions

• High Definition Transcranial Direct Current Stimulation (Other)

Trial Overview The study tests if low-level electric stimulation (active tDCS) on a specific brain area improves word finding abilities compared to sham (fake) stimulation. It includes verbal retrieval tests as primary outcome measures, other cognitive ability tests, and EEG monitoring before and after treatment.

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.

Who Is Running the Clinical Trial?

The University of Texas at Dallas

Lead Sponsor

Trials

71

Recruited

108,000+

Dr. Richard Benson

The University of Texas at Dallas

Chief Executive Officer since 2016

PhD in Molecular and Cell Biology from the University of Texas at Dallas

Dr. Patrizia Cavazzoni

The University of Texas at Dallas

Chief Medical Officer

MD from Harvard Medical School

University of Texas Southwestern Medical Center

Collaborator

Trials

1,102

Recruited

1,077,000+

Daniel K. Podolsky

University of Texas Southwestern Medical Center

Chief Executive Officer since 2008

MD from Harvard Medical School

Robert L. Bass

University of Texas Southwestern Medical Center

Chief Medical Officer since 2019

MD from University of Texas Southwestern Medical School

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]

Transcranial direct current stimulation (tDCS) did not show significant improvements in motor performance for all stroke patients immediately after treatment, but it did demonstrate effectiveness in enhancing motor function for patients with chronic stroke and mild-to-moderate impairments, based on a review of 15 studies with 315 subjects.

The results suggest that while tDCS has potential as a therapeutic tool in stroke recovery, its efficacy varies based on stroke characteristics, indicating that more research is needed to optimize its use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS): does it have merit in stroke rehabilitation? A systematic review. Marquez, J., van Vliet, P., McElduff, P., et al.[2022]

Transcranial direct current stimulation (tDCS) may enhance cognitive and motor training effects in patients with traumatic brain injuries or those who have undergone decompressive craniectomy, but the presence of skull defects can alter the effectiveness of the treatment.

Modeling with MRI-derived finite element head models showed that the impact of skull defects on electric current flow depends on various factors, such as electrode position and defect size, indicating that careful consideration is needed to ensure safety and efficacy in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in patients with skull defects and skull plates: high-resolution computational FEM study of factors altering cortical current flow. Datta, A., Bikson, M., Fregni, F.[2021]

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) 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) 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]

In a study involving 20 patients with posttraumatic encephalopathy, high-definition transcranial direct current stimulation (HD-tDCS) significantly improved cerebral blood flow (CBF) and cerebral blood volume (CBV), indicating enhanced oxygen delivery to brain tissue.

The treatment also reduced areas of hypoperfusion and ischemia, suggesting that HD-tDCS may be an effective non-pharmacologic intervention for improving cerebral perfusion after traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebral Hemodynamics After Transcranial Direct Current Stimulation (tDCS) in Patients with Consequences of Traumatic Brain Injury. Trofimov, AO., Kalentiev, G., Karelsky, M., et al.[2020]

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. Sweden pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation of the left prefrontal cortex improves attention in patients with traumatic brain injury: a pilot study. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Transcranial direct current stimulation (tDCS): does it have merit in stroke rehabilitation? A systematic review. [2022]

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

Transcranial direct current stimulation in patients with skull defects and skull plates: high-resolution computational FEM study of factors altering cortical current flow. [2021]

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

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

7. England pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]

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

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

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. 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]

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

Cerebral Hemodynamics After Transcranial Direct Current Stimulation (tDCS) in Patients with Consequences of Traumatic Brain Injury. [2020]